This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.

Start Date20 Apr 2027

Sponsor / Collaborator

National Cancer Institute

NCT07582172

/ RecruitingPhase 2IIT

Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS

This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and/or effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.

Start Date05 Apr 2027

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT05903937

/ Not yet recruitingPhase 1IIT

Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes Preconditioned With Percutaneous Hepatic Perfusion With Melphalan in Patients With Melanoma and Liver Metastases

Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma

Start Date31 Jan 2027

Sponsor / Collaborator

Region Västra Götaland

100 Clinical Results associated with Melphalan

100 Translational Medicine associated with Melphalan

100 Patents (Medical) associated with Melphalan

9,790

Literatures (Medical) associated with Melphalan

01 Sep 2026·American journal of ophthalmology case reports

Acral lentiginous melanoma metastases to the vitreous masquerading as uveitis: A case report

Article

Author: Arain, Zoya ; Al-Zangana, Rozhna ; Chaudhry, Amina Lateef ; Larkin, Kelly L ; Chahal, Rohini ; De la Garza Bravo, Maria ; Al-Zubidi, Nagham ; Chévez-Barrios, Patricia ; Gombos, Dan S ; Ahuja, Pranati

Purpose:

Cutaneous melanoma is the most common malignancy to present with vitreous metastasis. This report describes a case of vitreous metastasis from acral lentiginous melanoma masquerading as intermediate uveitis in a patient undergoing checkpoint inhibitor (CPI) therapy.

Observations:

This is an 86-year-old Caucasian female with Stage III Acral Lentiginous Melanoma of the left heel who was initiated on nivolumab and relatlimab along with intralesional talimogene laherparepvec (TVEC). Eight months later she developed blurry vision and floaters. She was diagnosed elsewhere with unilateral acute intermediate uveitis, leading to discontinuation of immunotherapy and initiation of topical difluprednate. Extensive infectious and autoimmune work-up including MRI of the brain and orbits was negative. Failing to improve, she presented to our hospital. Exam of the right eye showed best corrected visual acuity 20/50, intraocular pressure of 16 mmHg, keratic precipitates, 1+ anterior cells, and 2+ large amelanotic vitreous cells arranged in veils. The left eye was quiet. Vitreous biopsy revealed malignant melanoma cells, confirming metastatic melanoma. The patient underwent a therapeutic pars plana vitrectomy, intravitreal melphalan injection, and ocular radiotherapy, with resolution of vitreous metastasis.

Conclusions and Importance:

Several atypical, red flags in this patient may serve as clinical indicators; history of malignancy with locoregional progression, timing of immune CPI therapy to symptom onset, failure to treatment response, and large white, amelanotic vitreous cells arranged in veils. This case emphasizes the importance of maintaining a broad differential diagnosis in patients with atypical, or treatment resistant uveitis, especially in individuals with known underlying malignancy.

01 Sep 2026·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A computational study of perylene diimide as a potential nanocarrier for multiple drugs: adsorption, stability and release mechanisms

Article

Author: Nabat, Karim Youssef ; Ayub, Ali Raza ; Iqbal, Javed ; Salba ; Zubair, Sadia ; Bensahbane, Imane ; Sabir, Muhammad Zohaib ; Li, Hui

Our investigation involves the analysis of perylene diimide (PDI) through DFT estimation, evaluating its potential as a drug carrier framework for Hesperetin, Melphalan, Mercaptopurine, Resveratrol, and Zidovudine. Analysis of the bond lengths between the interacting atoms indicates that PDI demonstrates exceptional carrier capabilities for the delivery of Hesperetin, Melphalan, Mercaptopurine, Resveratrol, and Zidovudine, with measurements of 2.10, 1.82, 2.24, 2.01, and 2.46 Å, respectively. The presence of hydrogen bonding interactions can be analyzed through Noncovalent Interaction (NCI) and Quantum Theory of Atoms in Molecules (QTAIM) methodologies. The dipole moments and chemical descriptors indicate the significant reactivity of the PDI nanocarriers with Hesperetin, Melphalan, Mercaptopurine, Resveratrol, and Zidovudine drugs. According to the analysis of optoelectronic properties, PDI@Mercaptopurine demonstrates a significant adsorption affinity for the perylene diimide (PDI) complex in comparison to other complexes. Moreover, the release of Mercaptopurine from the nanocarrier is enhanced by the stability of adsorption during protonation in an acidic environment, in conjunction with the brief recovery time anticipated for the PDI nanocarrier surface. After considering all the factors mentioned before, it is clear that PDI nanocarriers have a lot of promise as anticancer drug delivery methods.

01 Aug 2026·PEDIATRIC BLOOD & CANCER

Simple Interventions Can Improve Access to Autologous Stem Cell Transplant in Low‐ and Lower‐Middle‐Income Countries by Reducing Complexity, Lowering Costs, and Minimizing Infectious Risks

Article

Author: Hans, Rekha ; Lamba, Divjot Singh ; Chandel, Swati ; Sharma, Ratti Ram ; Peters, Nitin J. ; Menon, Prema ; Kapoor, Rakesh ; Srinivasan, Radhika ; Jain, Richa ; Madan, Renu ; Das, Reena ; Bhattacharya, Anish ; Palla, Swetha ; Bansal, Deepak ; Trehan, Amita ; Peyam, Srinivasan ; Kakkar, Nandita ; Kumar, Rajender

ABSTRACT:

Background:

The aim was to enhance access to autologous stem cell transplant (ASCT) for high‐risk neuroblastoma in a public hospital in a lower‐middle‐income country, while ensuring safety.

Methods:

Data from a single center were analyzed in this ambispective, observational study spanning 12 years (2012–2023). The adaptations included performing ASCT in isolation rooms within the general ward, storing stem cells at 2°C–6°C without cryopreservation for 7 days, utilizing plerixafor for stem cell mobilization, no central lines, minimizing venipunctures for sampling, no antibacterial/antifungal/antiviral prophylaxis, administering pegylated‐G‐CSF on Day +4, avoiding platelet transfusion for asymptomatic thrombocytopenia, prednisolone for preventing engraftment syndrome, and early discharge upon rising white cell count and monocytosis.

Results:

Seventy‐three patients were treated on the backbone of the high‐risk neuroblastoma study‐1 of SIOP‐Europe (SIOPEN). The median age was 38 months. Sixty‐six (90.4%) patients had Stage 4 disease. A regimen of busulfan+melphalan was administered to 62 (84.9%) patients. Median CD34 cell count and stem cell viability were 5.2 × 10 6 /kg and 91.5%. The median hospital stay was 20 days. At discharge, the median absolute neutrophil and platelet counts were 0.60 × 10 9 /L and 19 × 10 9 /L. After 2017, there was a reduction in the number of aphereses ( p < 0.001), blood transfusions ( p = 0.003), amphotericin ( p = 0.012), and venipunctures ( p = 0.045). Forty (54.8%) patients died; relapse: 33 (82.5%); progressive disease: five (12.5%); and treatment‐related mortality: two (5%). There was no case of engraftment failure. The median follow‐up for surviving patients was 55.3 months. Five‐year overall survival (OS) and event‐free survival (EFS) were 34.6% ± 6.6% and 27% ± 5.8%. Survival was comparable to our historical cohort of 28 patients treated without ASCT (4‐year EFS: 29.3%; 4‐year OS: 29.3%).

Conclusion:

In our cohort, the incorporation of ASCT into multimodality therapy was feasible with resource‐adapted strategies; however, this did not translate into a meaningful improvement in survival outcomes when compared with our historical non‐transplant cohort.

265

News (Medical) associated with Melphalan

21 Aug 2026

·www.biospace.com

European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care

Approval is based on unprecedented Phase 3 data showing statistically significant improvements in progression-free and overall survival versus standard of care regimens 1 This immunotherapy doublet regimen demonstrated durable disease control as early as second line, with more than 90% of patients who were progression-free at six months remaining progression-free at three years 1 BEERSE, BELGIUM, Aug. 21, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced that the European Commission (EC) has approved an indication extension for TECVAYLI ® (teclistamab) in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM. Complementary mechanisms of action underpin this immunotherapy doublet Teclistamab and daratumumab work in a complementary manner, with daratumumab modulating the immune system to enhance T-cell fitness and activation, thereby amplifying teclistamab-mediated killing of myeloma cells. 1 ,2 Expert and company perspectives on advancing the standard of care in RRMM “Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making earlier access to the most effective treatments increasingly important,” said María-Victoria Mateos, M.D., Director of the Myeloma Unit at the University Hospital of Salamanca, Spain. “Today’s approval of teclistamab in combination with daratumumab marks an important advance by providing physicians with an off-the-shelf, steroid-sparing, immunotherapy option that has demonstrated meaningful improvements in progression-free and overall survival, with the potential to redefine treatment expectations as early as second line.” "This new indication for teclistamab plus daratumumab brings forward a new standard of care for patients in Europe living with relapsed or refractory multiple myeloma," said Ester in 't Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "By combining the complementary mechanisms of teclistamab, a BCMAxCD3 bispecific antibody, with daratumumab, a well-established standard of care that helps modulate the immune system, we can deliver meaningful long-term outcomes earlier in the treatment journey, where they have the greatest opportunity to influence the disease trajectory and redefine expectations for patients.” “Today’s approval reflects our ongoing commitment to addressing the diverse needs of patients with multiple myeloma, giving them more options at every stage of their disease,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “By continuing to invest in scientific innovation and practice-changing research, we aim to redefine what is possible for patients today, while moving closer to a future where long-term disease control, and ultimately cure, becomes an achievable goal." Unprecedented Phase 3 study data demonstrate significant survival benefits versus standard of care, representing a potential new benchmark in RRMM The EC approval is supported by data from the Phase 3 MajesTEC-3 study ( NCT05083169 ), which evaluated the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with RRMM who have received 1–3 prior lines of therapy. 3 Source: Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine 2025; Full article and supplementary material. Available at: . Last accessed: August 2026. The study demonstrated clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS). 1 At nearly three years of follow-up, teclistamab plus daratumumab SC reduced the risk of disease progression or death by 83.4% compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p <0.001). 1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, highlighting the durability of response observed with this regimen. 1 OS favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p <0.0001), with treatment benefit observed across all prespecified subgroups. 1, 2 At three years, OS rates were 83.3% for the combination compared with 65.0% for standard of care. 1 Teclistamab combination demonstrated manageable safety profile The safety pro teclistamab plus daratumumab SC was consistent with the well-known profiles of the individual therapies and no new safety signals were identified. 1, 4 , 5 All cases of cytokine release syndrome were Grade 1/2 and did not lead to treatment discontinuation. 1 Cytopenia and infection were the most commonly observed Grade 3/4 treatment-emergent adverse events (TEAEs). 1 Treatment discontinuations due to TEAEs were low and occurred at similar rates between study arms (4.6% [teclistamab] vs. 5.5% [DPd/DVd]). 1 About the MajesTEC-3 Study MajesTEC-3 ( NCT05083169 ) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy. 1, 3 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. 3 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 3 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 7 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 4,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. 1,5 Teclistamab is currently being evaluated in several combination studies. 4 ,9,10,11 To date, more than 30,700 patients have been treated worldwide with teclistamab. 12 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: . ▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 4 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide. 13 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 5,14 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training. 5,15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 5 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 5,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 5 Daratumumab may also have an effect on normal cells. 5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 17,18,19,20,21,22,23,24,25,26 For further information on daratumumab, please see the Summary of Product Characteristics at: . About Multiple Myeloma Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 27,28 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 29,30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died. 31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 32,33,34 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 35 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MajesTEC-3 Phase 3 clinical trial TECVAYLI Teclistamab DARZALEX Daratumumab Teclistamab and daratumumab combination TECVAYLI and DARZALEX combination Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy CD38-targeted therapy BCMA-targeted bispecific therapy Combination immunotherapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment *Maria-Victoria Mateos, M.D., Ph.D., Consultant Physician in Hematology, University Hospital of Salamanca, has provided consulting, advisory, and speaking services to Johnson & Johnson; she has not been paid for any media work. END References: 1 Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine. 2025; Full article and supplementary material. Available at: . Last accessed: August 2026. 2 Mateos M-V, et al. Phase 3 Randomized Study of Teclistamab plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone with either Pomalidomide or Bortezomib (DPd/DVd) in patients (pts) with Relapsed Refractory Multiple Myeloma (RRMM): Results of the MajesTEC-3 Study. Oral Presentation #06. American Society of Hematology (ASH) Annual Meeting; 06-09 December, 2025. 3 ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: August 2026. 4 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: August 2026. 5 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: August 2026. 6 Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: August 2026. 7 Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: August 2026. 8 Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505. 9 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: August 2026. 10 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: August 2026. 1 1 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: August 2026. 1 2 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of June 2026. 1 3 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of August 2026. 1 4 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: August 2026. 1 5 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 16 Fedele G, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNy cytokines and proliferation. Mediators Inflamm. 2013;564687. 1 7 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. 1 8 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115. 1 9 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. 20 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. 2 1 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. 2 2 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 2 3 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. 2 4 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. 2 5 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 2 6 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. 2 7 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 2 8 Myeloma UK. What is myeloma? Available at: . Last accessed: August 2026. 29 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 30 Mayo Clinic. Multiple Myeloma. Available at: 20353378 . Last accessed: August 2026. 31 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2024, by Country. Multiple Myeloma. Available at: . Last accessed: August 2026. 32 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 33 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 34 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. 35 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: August 2026. CP-595345 August 2026 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com

Phase 3Clinical ResultDrug ApprovalImmunotherapyLicense out/in

26 Jun 2026

·www.biospace.com

CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma

Recommendation supported by unprecedented Phase 3 data, demonstrating that TECVAYLI ® in combination with daratumumab achieved statistically significant improvements in progression-free and overall survival versus standard of care 1 Pending approval, this novel complementary immunotherapy combination is positioned to delay disease progression for patients treated as early as second line, with 83% of patients alive at three years 1 BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI ® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. Advancing complementary immunotherapies to improve patient outcomes Teclistamab and daratumumab work in a mechanistically complementary manner by engaging multiple tumour and immune directed pathways. 1,2 When combined, daratumumab modulates the immune system to create a more favourable immune microenvironment and enhances T-cell fitness and activation, amplifying teclistamab-mediated killing of myeloma cells. 1,2 This combination improves patient outcomes by using immunotherapies earlier in the treatment journey when patients’ immune systems are more robust. 1, 2 Expert and company perspectives support the earlier use of teclistamab combination in multiple myeloma care “Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months. More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years, highlighting the potential for durable long-term disease control.” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “This CHMP opinion marks an important step towards establishing the off-the-shelf immunotherapy combination of teclistamab plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma.” “At Johnson & Johnson our ambition is to leverage the full potential of our comprehensive multiple myeloma portfolio, to strengthen patient outcomes at every stage of the treatment continuum,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By advancing innovative immunotherapies such as teclistamab and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care.” Teclistamab plus daratumumab SC achieves meaningful and sustained improvements in patient outcomes The CHMP recommendation is supported by data from the Phase 3 MajesTEC-3 study ( NCT05083169 ), evaluating the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients who have received 1–3 prior lines of therapy. 3 At nearly three years of follow-up, results show an 83.4% reduction in the risk of disease progression or death in patients treated with teclistamab plus daratumumab SC, compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p <0.0001). 1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, demonstrating sustained disease control over time. 1 Overall survival (OS) favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p <0.0001), with treatment benefit observed across all prespecified subgroups. 1 ,2 At three years, OS rates were 83.3% for the combination and 65.0% for standard of care. 1 Both progression-free survival and OS benefits were clinically meaningful and statistically significant. 1 Manageable safety pro with teclistamab combination Teclistamab plus daratumumab SC demonstrated a safety pro with the well-known profiles of the individual therapies. 1 , 3 , 4 All cases of cytokine release syndrome were Grade 1/2, did not lead to treatment discontinuation, and were manageable and resolved. 1 Rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable to standard of care regimens (95.1% vs. 96.6%) with cytopenia and infection most commonly observed. 1 Grade ≥3 infections decreased over time with the use of immunoglobulin supplementation and infection prophylaxis, along with a switch to monthly dosing. 2 Discontinuations due to TEAEs were low and similar between study arms (4.6% vs. 5.5%). 1 About the MajesTEC-3 Study MajesTEC-3 ( NCT05083169 ) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed or refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy. 5 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. 5 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 5 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 7 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 3 , 8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. 1,3 Teclistamab is currently being evaluated in several combination studies. 5 , 9,10 ,11 To date, more than 26,000 patients have been treated worldwide with teclistamab. 1 2 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: . ▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 3 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide. 1 3 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 5, 1 4 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training. 5, 15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 5 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 5 ,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 5 Daratumumab may also have an effect on normal cells. 5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 17,18,19,20,21,22,23,24,25,26 For further information on daratumumab, please see the Summary of Product Characteristics at: . About Multiple Myeloma Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 2 7 ,2 8 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 2 9 , 30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died. 31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 32 , 33 ,3 4 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 3 5 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MajesTEC-3 Phase 3 clinical trial TECVAYLI Teclistamab DARZALEX Daratumumab Teclistamab and daratumumab combination TECVAYLI and DARZALEX combination Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy CD38-targeted therapy BCMA-targeted bispecific therapy Combination immunotherapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment END References: 1 Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026;394(8):739-752. 2 Mateos MV, et al. Phase 3 Randomized Study of Teclistamab plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone with either Pomalidomide or Bortezomib (DPd/DVd) in patients (pts) with Relapsed Refractory Multiple Myeloma (RRMM): Results of the MajesTEC-3 Study. Oral Presentation #06. American Society of Hematology (ASH) Annual Meeting; 06-09 December, 2025. 3 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: June 2026. 4 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: June 2026. 5 ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: June 2026. 6 Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: June 2026. 7 Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: June 2026. 8 Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;287(6):494-505. 9 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: June 2026. 10 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: June 2026. 11 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: June 2026. 12 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of March 2026. 13 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of December 2025. 14 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: June 2026. 15 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 16 Fedele G, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNy cytokines and proliferation. Mediators Inflamm. 2013;564687. 17 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. 18 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019;380(22):2104-2115. 19 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. 20 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. 21 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. 22 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 23 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. 24 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. 25 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 26 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024; 390(4):301-313. 27 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 28 Myeloma UK. What is myeloma? Available at: . Last accessed: June 2026. 29 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 30 Mayo Clinic. Multiple Myeloma. Available at: . Last accessed: June 2026. 31 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: . Last accessed: June 2026. 32 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 33 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 34 McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111. 35 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: June 2026. CP-583164 June 2026 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com

Clinical ResultPhase 3Drug ApprovalLicense out/inImmunotherapy

14 Jun 2026

·www.biospace.com

New TALVEY®▼(talquetamab) plus daratumumab data demonstrate the potential strength of a novel bispecific combination in earlier-line relapsed or refractory multiple myeloma

TALVEY ® plus daratumumab with or without pomalidomide showed progression-free survival of up to 81.3% and overall survival of up to 89.2% at 24 months 1 MonumenTAL-3 is the third positive study in recent months from Johnson & Johnson’s bispecific portfolio and is the first Phase 3 study of a GPRC5D bispecific investigational combination 1 ,2,3 Results reinforce Johnson & Johnson’s leadership in multiple myeloma, advancing bispecific combinations earlier in the treatment journey, and expanding options to match the right treatment to the right patient and stage of disease 1 BEERSE, BELGIUM, June 13, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced results from the investigational Phase 3 MonumenTAL-3 study. 1 The results showed that TALVEY ® (talquetamab), a GPRC5D bispecific antibody, in combination with daratumumab with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72.0%, and clinically meaningful reduction of up to 53.0% in the risk of death, compared to the standard regimen of daratumumab, pomalidomide, and dexamethasone (DPd) in patients with relapsed or refractory multiple myeloma (RRMM). 1 Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months. 1 This is the first Phase 3 study to demonstrate superior PFS with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma, underscoring the potential of this regimen to advance bispecific combinations earlier in the treatment paradigm. 1 Results were presented at the 2026 European Hematology Association (EHA) Annual Meeting ( Abstract #S100 ), with simultaneous publication in The New England Journal of Medicine . 1 ,4 Expert and company perspectives support bispecific combinations in earlier lines “The impressive results from this study point to the promise of talquetamab plus daratumumab as a potential new bispecific combination for patients with relapsed or refractory multiple myeloma,” said Peter Voorhees, M.D., Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine.* “Talquetamab works with daratumumab in earlier lines—a critical time for treating patients with the most effective regimens.” “Daratumumab-based regimens have transformed the treatment of multiple myeloma and remain a foundational therapy across all stages of disease. The MonumenTAL-3 study builds on this legacy, combining daratumumab with talquetamab, the first GPRC5D bispecific antibody, to further expand the effective options available to patients in the relapsed/refractory setting,” said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “These findings reflect Johnson & Johnson’s commitment to leveraging the power of our portfolio to advance novel combination regimens that address the evolving and highly heterogeneous needs of patients living with multiple myeloma.” “The MonumenTAL-3 findings underscore our commitment to bringing bispecific combinations into earlier lines of therapy, building on the strength and breadth of Johnson & Johnson’s multiple myeloma portfolio,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson. “These results add to our growing body of evidence across bispecific antibodies and reinforce our strategy of advancing differentiated immunotherapies to better match the right therapy to the right patient at each stage of disease.” Novel mechanism spares healthy immune cells Talquetamab targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body). 1 GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-Cells . 1 Talquetamab works by targeting myeloma cells while largely sparing healthy B-cells. 1 With daratumumab priming the immune system for enhanced talquetamab activity, the combination benefits from complementary mechanisms of action, supporting the potential effectiveness of this approach in multiple myeloma. 1 ,5,6 Phase 3 MonumenTAL-3 study results The MonumenTAL-3 study evaluated talquetamab with daratumumab subcutaneous (SC) or talquetamab with daratumumab SC (Tal-D) and pomalidomide (Tal-DP) compared to DPd in patients with RRMM who have received at least one prior line of therapy. 1 At a median follow-up of two years (24.6 months), results showed significant improvement in PFS for Tal-DP (hazard ratio [HR], 0.28; 95% confidence interval [CI], 0.20-0.40; p <0.0001) and Tal-D (HR, 0.33; 95% CI, 0.24-0.46; p <0.0001). 1 At 24 months, Tal-DP showed a PFS rate of 81.3% and Tal-D showed a PFS rate of 77.6%. 1 All participants (N=864) were previously exposed to lenalidomide and a proteasome inhibitor and received at least one prior line of therapy. 1 Most patients enrolled were refractory to lenalidomide (85.1%) and their last line of therapy (93.4%), and some were exposed to an anti-CD38 antibody (11.8%). 4 Statistically significant improvements compared to DPd were observed across key secondary endpoints of overall response rate (ORR), complete response or better (≥CR), and minimal residual disease (MRD)-negative ≥CR (10 -5 , next-generation sequencing [NGS]) for Tal-DP and Tal-D. 1 ORRs (88.2%, 88.5%, 77.6%), ≥CR rates (71.1%, 68.9%, 34.5%) and MRD-negative ≥CR rates (52.3%, 46.3%, 15.9%) were significantly higher for Tal-DP and Tal-D vs DPd, respectively, after two years median follow-up. 1 Clinically meaningful improvement in OS was shown with Tal-DP (HR, 0.47; 95% CI, 0.30-0.73, p =0.0006) and Tal-D (HR, 0.51; 95% CI, 0.33-0.78, p =0.0015) vs DPd. 1 At 24 months, Tal-DP delivered an OS rate of 89.2% and Tal-D delivered an OS rate of 87.9%. 1 The overall safety profiles for the talquetamab plus daratumumab SC treatment arms were consistent with the known safety profiles of each monotherapy, and a reduced risk of severe infections were observed in the Tal-D arm compared to the standard of care. 1 Overall, rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable across treatment arms (94.9% with Tal‑DP, 74.8% with Tal‑D, and 91.5% with DPd). 4 Infections occurred at rates of 87.3% (Tal‑DP), 84.3% (Tal‑D), and 83.0% (DPd). 1 When analysing severe infections, Tal-D had the lowest rate of Grade 3/4 infections (29.2%), followed by Tal-DP (37.7%), and DPd (42.2%). 1 There were some instances of Grade 5 adverse events (AEs) across the entire population of the study; the Tal-DP arm saw the fewest (1.8%), followed by Tal-D (4.0%) and DPd (4.6%), with approximately 0.7% (Tal-DP), 1.5% (Tal-D), and 1.8% (DPd) due to infections. 4 Treatment discontinuations due to AEs occurred in 10.5% of Tal‑DP, 8.0% of Tal‑D, and 6.7% of DPd patients. 1 At data cutoff, 70.3% (Tal-DP), 69.7% (Tal-D), and 47.3% (DPd) of patients remained on study treatment. 1 Cytokine release syndrome occurred in 67.8% (Tal‑DP) and 58.4% (Tal‑D) of patients and was predominantly Grade 1–2, while immune effector cell‑associated neurotoxicity syndrome was infrequent (2.9% and 1.8% respectively), with no Grade ≥4 events reported. 1 Across Tal-DP, Tal-D and DPd, respectively, taste change (72.8%, 74.8%, 3.9%) and weight loss (45.7%, 38.3%, 7.4%) AEs along with ataxia/balance disorders (Grade 1-2: 11.6%, 10.2%, 0.4%; Grade 3: 2.9%, 2.2%, 0.0%) were primarily low grade and rarely led to talquetamab discontinuation, supporting the manageable safety profile. 1 , 4 Based on these results, Johnson & Johnson is working with regulatory bodies globally to bring the benefits of talquetamab plus daratumumab SC with or without pomalidomide to eligible patients as quickly as possible. On 31 March 2026, the Company submitted a type II variation to the European Medicines Agency (EMA) for the use of talquetamab in combination with daratumumab, or in combination with daratumumab and pomalidomide, for the treatment of adult patients with RRMM who have received at least one prior therapy. About the MonumentTAL-3 study The MonumenTAL-3 ( NCT05455320 ) study is an ongoing Phase 3 study of talquetamab in combination with daratumumab subcutaneous (SC) with or without pomalidomide compared to daratumumab SC combined with pomalidomide and dexamethasone in patients with relapsed of refractory multiple myeloma (RRMM) who have received at least one prior line of therapy. 7 The primary endpoint is progression-free survival (PFS) and secondary endpoints include overall response rate (ORR), complete response or better (≥CR), minimal residual disease (MRD)-negative ≥CR (10 -5 by next-generation sequencing), overall survival (OS) and safety. 7 The MonumenTAL-3 study is a part of the MonumenTAL clinical program, which includes exploring the potential of talquetamab as a combination regimen. 7 About Talquetamab Talquetamab received conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. 8 The U.S. FDA also granted talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. 9 Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors. 8 To date, more than 11,000 patients have been treated with talquetamab worldwide. 10 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the Summary of Product Characteristics . In line with the European Medicine Agency’s regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. ▼ In line with EMA regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. 8 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide. 11 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 12 ,13 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training. 13 ,14 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 13 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 13 ,15 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 13 Daratumumab may also have an effect on normal cells. 13 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 16 ,17,18,19,20,21,22,23,24,25 For further information on daratumumab, please see the Summary of Product Characteristics at: . About Multiple Myeloma Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 26 ,27 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 28 ,29 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died. 30 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 31 ,32,33 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 34 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of talquetamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent *Peter Voorhees, M.D., Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. END 1 Voorhees P, et al. Phase 3 randomized study of talquetamab (TAL) plus daratumumab (DARA) ± pomalidomide (POM) vs DARA plus DOM ad dexamethasone (DPD) in relapsed/refractory multiple myeloma (RRMM): MonumenTAL-3. Presented at: 2026 European Hematology Association Congress; June 13, 2026; Stockholm. 2 Touzeau C, et al. Teclistamab monotherapy in multiple myeloma with 1–3 prior lines of therapy. Presented at: 2026 American Society of Clinical Oncology (ASCO); May 29, 2026; Chicago. 3 Mateos MV, et al. Phase 3 Randomized Study of Teclistamab plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone with either Pomalidomide or Bortezomib (DPd/DVd) in patients (pts) with Relapsed Refractory Multiple Myeloma (RRMM): Results of the MajesTEC-3 Study. Oral Presentation #06. American Society of Hematology (ASH) Annual Meeting; 06-09 December, 2025. 4 Mina R, et al. Talquetamab–daratumumab in relapsed or refractory myeloma. N Engl J Med. 13 June 2026. 5 Chari A, et al. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025;146(24). 6 Verkleij C, et al. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. Blood. 2021;5(8):2195-2215. 7 ClinicalTrials.gov. MonumenTAL‑3: Study of talquetamab in combination with daratumumab ± pomalidomide versus daratumumab + pomalidomide + dexamethasone in relapsed or refractory multiple myeloma (NCT05455320). Available at: . Last accessed: June 2026 8 European Medicines Agency. TALVEY Summary of Product Characteristics. Available at: . Last accessed: June 2026. 9 FDA. FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma. Available at: . Last accessed: June 2026 10 J&J Data on File. Number of Patients Treated with TALVEY ® worldwide as of March 2026. 11 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of December 2025. 12 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: June 2026. 13 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: June 2026. 14 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 15 Fedele G, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNy cytokines and proliferation. Mediators Inflamm. 2013;564687. 16 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. 17 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115. 18 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. 19 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. 20 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. 21 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 22 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. 23 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. 24 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 25 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. 26 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 27 Myeloma UK. What is myeloma? Available at: . Last accessed: June 2026. 28 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 29 Mayo Clinic. Multiple Myeloma. Available at: . Last accessed: June 2026. 30 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: $0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27 . Last accessed: June 2026. 31 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 32 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 33 McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111. 34 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: June 2026. CP-585393 June 2026 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com

Clinical ResultPhase 3ImmunotherapyDrug ApprovalLicense out/in

100 Deals associated with Melphalan

External Link

KEGG	Wiki	ATC	Drug Bank
D00369	Melphalan	L01AA03	DB01042

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Leukemia	Japan	Sandoz KK	04 Apr 2001
Lymphoma	Japan	Sandoz KK	04 Apr 2001
Solid tumor	Japan	Sandoz KK	04 Apr 2001
Ovarian adenocarcinoma	China	Aspen Pharmacare Australia Pty Ltd.	01 Jan 1998
Polycythemia Vera	China	Aspen Pharmacare Australia Pty Ltd.	01 Jan 1998
Multiple Myeloma	United States	Apotex, Inc.	17 Jan 1964
Breast Cancer	Canada	Apotex, Inc.	01 Jan 1963
Ovarian Cancer	Canada	Apotex, Inc.	01 Jan 1963

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 2	United States	Celgene Corp.	22 Jun 2016
Smoldering Multiple Myeloma	Phase 2	Spain	Celgene Corp.	01 May 2015
Smoldering Multiple Myeloma	Phase 2	Spain	Amgen, Inc.	01 May 2015
Unresectable Melanoma	Phase 2	United States	Bristol Myers Squibb Co.	01 Feb 2011
Relapse multiple myeloma	Phase 2	United States	Celgene Corp.	01 Aug 2010
Anemia, Refractory, With Excess of Blasts	Phase 2	Canada	Celgene Corp.	01 Jan 2008
Chronic Myelomonocytic Leukemia	Phase 2	Canada	Celgene Corp.	01 Jan 2008
Secondary Myelodysplastic Syndrome	Phase 2	Canada	Celgene Corp.	01 Jan 2008
Plasma Cell Leukemia	Phase 2	United States	GSK Plc	19 Nov 2001
Recurrent Multiple Myeloma	Phase 1	United States	Novartis Pharmaceuticals Corp.	10 Jul 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04937634 (Pubmed \| Eur J Drug Metab Pharmacokinet)	Phase 1	Multiple Myeloma \| Lymphoma	20	Melphalan	vgzozssooo(ulinwomxgd) = znyvvhyakz yvovojfjgq (uojxzibcji ) View more	Positive	01 Jul 2026
NCT04994977 (CTgov)	Phase 1	Choroid Plexus Papilloma \| Choroid Plexus Carcinoma	1	Carboplatin+Melphalan+Topotecan	pdlrzlksjr = ggoyvlrheu chcaffspit (igtdvwdpkj, zfwjlwjxsh - pgndabqnqr) View more	-	08 Jun 2026
ASCO2026	Not Applicable	Relapse multiple myeloma	242	Melphalan-based therapy with stem cell rescue	iuspakezep(mqvooptwqz) = xqvonyhadz gtduhistxa (minzuyxalw ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Relapse multiple myeloma	242	Talquetamab	iuspakezep(mqvooptwqz) = sjmcwpkqkz gtduhistxa (minzuyxalw ) View more	Positive	29 May 2026
EHA2026	Not Applicable	Relapse multiple myeloma	430	Melphalan flufenamide+dexamethasone	venzajcspn(hsozacmzjz) = zncofhgqhn fgieuqmjmb (ixrwpkpvid ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Relapse multiple myeloma	430	Melphalan flufenamide+dexamethasone (from the OCEAN trial)	mmwmkgrhmm(fxtcqjygnb) = ombvmjcgkg phgskxexlu (lwodhlwsow ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Multiple Myeloma	202	melphalan (Single-day HDM)	yjgamyjksh(eefcjcpfgn) = uewzitvxzy kiaynugsob (gffrnbeoik ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Multiple Myeloma	202	melphalan (Split-dose HDM)	yjgamyjksh(eefcjcpfgn) = zcqohrboir kiaynugsob (gffrnbeoik ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Refractory Acute Leukemia	37	High-dose melphalan	rsaqwgodql(qbjuiuhaiv) = wynbpdfuxv hgpcgvjwiz (fkndjxmetu ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Multiple Myeloma	99	Melphalan-prednisone	mhtftvyndz(rtbcvzljse) = onrnbgtiec vbzjsjmtgo (wlljcbrwnj ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Multiple Myeloma	53	Bortezomib-Melphalan-Prednisone (VMP) regimen	phyasyroey(cijmlqcwfs) = mttngfdbmi kxqlfliohd (fgazfbmbse ) View more	Positive	12 May 2026
NCT04897139 (EHA2026)	Phase 2	Lymphoma	203	FludarabineMelphalanEtoposideBusulfanine + FludarabineMelphalanEtoposideBusulfan + FludarabineMelphalanEtoposideBusulfane + FludarabineMelphalanEtoposideBusulfann	rpoespwlvm(veegcwfize) = nexekwuftb dgdvfczolb (npmfnphedw, 8.3 - 18.8) View more	Positive	12 May 2026
EHA2026	Not Applicable	Acute lymphoblastic leukemia recurrent	258	Intensified myeloablative conditioning (iMAC) regimen (MAC combined with melphalan or thiotepa)	ghegqlprwf(zvsthqqqzu) = qvjgfnictw bhttsqnlaa (uqelrtrjiy ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Acute lymphoblastic leukemia recurrent	258	Conventional myeloablative conditioning (cMAC)	ghegqlprwf(zvsthqqqzu) = ebuqbbdrtn bhttsqnlaa (uqelrtrjiy ) View more	Positive	12 May 2026

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