CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Refractory Multiple MyelomaRelapse multiple myelomaMultiple Myeloma+ [6]

Inactive Indication-

Originator Organization

Janssen Pharmaceuticals, Inc.

Active Organization

Johnson & Johnson (China) Investment Ltd.Janssen-Cilag Pty Ltd.Janssen Research & Development LLC

+ [9]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Aug 2023),

Multiple Myeloma

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Sequence Code 10086313H

Source: *****

Sequence Code 10086327L

Source: *****

Sequence Code 453116282H

Source: *****

Sequence Code 525754800L

Source: *****

Clinical Trials associated with Talquetamab

NCT07474961

/ Not yet recruitingPhase 4IIT

A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol

BLOOD-dose is a multicentre, adaptive, randomized, multidomain platform trial designed to optimize treatment dosing strategies in adult patients with haematological diseases.
The BLOOD-dose core protocol outlines the overall clinical trial design that applies to all included interventions, while domain-specific appendices (DSA) detail the unique characteristics of each domain and specify domain-specific interventions.
New domains will be incorporated over time to address distinct dose-optimization research questions across different haematological conditions and interventions.

Start Date01 Mar 2027

Sponsor / Collaborator

Rigshospitalet

NCT07657312

/ Not yet recruitingPhase 2IIT

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect the lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible paralysis and/or coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.

Start Date01 Aug 2026

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+2]

NCT07029776

/ Not yet recruitingPhase 2

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

Start Date01 Jul 2026

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Talquetamab

100 Translational Medicine associated with Talquetamab

100 Patents (Medical) associated with Talquetamab

133

Literatures (Medical) associated with Talquetamab

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Costs per responder for patients with relapsed or refractory multiple myeloma treated with Talquetamab compared with usual care

Article

Author: Mu, Fan ; Patel, Neel ; Yang, Chelsey ; Jiao, Tianze ; Liu, Yi-Hsuan ; Grajales-Cruz, Ariel F. ; Lee, Hans C. ; Zhang, Xinke ; Wang, Jiamin ; Goble, Joseph

AIMS:

To evaluate costs per responder for patients with triple-class exposed (TCE) relapsed or refractory multiple myeloma (RRMM) receiving talquetamab (Tal) on weekly (QW) and biweekly (Q2W) dosing schedules, compared with usual care from a United States commercial payer's perspective.

METHODS:

A cost per responder model was developed over a 6-month time horizon, incorporating pre-progression and post-progression costs. For Tal QW and Tal Q2W, pre-progression costs included costs of drug acquisition, inpatient step-up doses (hospitalization, pre-medication, and tocilizumab), outpatient visits, and monitoring. Pre-progression costs for usual care were estimated based on a weighted average of the 10 most used regimens in a real-world LocoMMotion/MoMMent study, including costs of acquisition, administration, co-medication, and monitoring. Post-progression costs included subsequent treatment for a subset of patients and terminal care costs prior to death. All costs were reported in 2025 United States Dollars. Clinical data of overall response rate (ORR), progression-free survival, and overall survival were obtained from an indirect treatment comparison using MonumenTAL-1 (September 2024 data cut) and LocoMMotion/MoMMent (October 2022 and August 2023 data cuts) as data sources. Deterministic sensitivity analyses and scenario analyses were conducted to assess the robustness of model results.

RESULTS:

Over the 6-month period, the total cost of care was $179,556 for usual care, $295,993 for Tal QW, and $315,135 for Tal Q2W. Despite higher costs, Tal demonstrated superior ORR, resulting in lower cost per responder: $575,962 for usual care, $405,470 for Tal QW, and $443,165 for Tal Q2W, representing a 23-30% reduction in cost per responder with Tal. Sensitivity and scenario analyses showed consistent findings.

CONCLUSION:

Although Tal QW and Q2W are associated with higher total per-patient costs compared with usual care, they offer improved clinical effectiveness, resulting in lower cost per responder. These findings suggest greater economic value for Tal in the treatment of TCE RRMM.

01 Jun 2026·EUROPEAN JOURNAL OF HAEMATOLOGY

Salvage Therapy in Multiple Myeloma With Prior T‐Cell Engager Exposure: Talquetamab, Elranatamab or Teclistamab in Combination With Pomalidomide

Article

Author: Phull, Pooja ; Siegel, David ; Biran, Noa ; Parmar, Harsh ; Di Palma‐Grisi, James ; Vesole, David

ABSTRACT:

Multiple myeloma (MM) is a hematologic malignancy manifested by proliferation of clonal plasma cells leading to end‐organ damage. Despite significant advancements in therapeutics, it remains incurable. Cellular therapies such as chimeric antigen receptor (CAR‐T) therapy and T‐cell engager (TCE) therapies have delivered high overall response rates, but almost all patients relapse and subsequent options are limited particularly in view of the increasing prevalence of prior exposure to anti‐BCMA agents and immunomodulator (IMiD) therapies. Our retrospective review of 12 patients between January 2024 and December 2025 who received a combination of talquetamab, elranatamab, or teclistamab with pomalidomide found that 11 of 12 had an overall response, of whom 6 had very good partial response or better at median follow‐up of 9.9 months. All 12 patients were prior exposed to pomalidomide, of whom 10 had been exposed to prior CAR‐T with a median of 7 prior lines of therapy. Safety profiles were favorable: 6 patients experienced Grade 1 CRS, 7 experienced Grade III neutropenia, and 7 of 8 patients receiving talquetamab experienced on‐target, off‐tumor side effects like dysgeusia and skin dryness.

01 Jun 2026·JCO Oncology Practice

Defining the Rates of Cytokine Release Syndrome Associated With Talquetamab Step-up Doses

Article

Author: Giralt, Sergio ; Mailankody, Sham ; Shah, Gunjan L. ; Modelevsky, Lisa ; Mitchell, Aaron ; Landau, Heather J. ; Tan, Carlyn R. ; Patel, Dhwani ; Korde, Neha ; Firestone, Ross S. ; Hashmi, Hamza ; Hultcrantz, Malin L. ; Chan, Amelia ; Hamadeh, Issam S. ; Scordo, Michael ; Rajeeve, Sridevi ; Wang, Alice X. ; Shekarkhand, Tala ; Hassoun, Hani ; Lesokhin, Alexander M. ; Shah, Urvi A. ; Usmani, Saad Z. ; Maclachlan, Kylee

PURPOSE:

Talquetamab is a G protein–coupled receptor class C group 5 member D T-cell–engaging antibody, approved for relapsed/refractory multiple myeloma (RRMM). In the MonumenTAL-1 clinical trial, cytokine release syndrome (CRS) occurred at a frequency of 77%; however, there was no assessment of CRS rates by step-up dose. The primary objective of this study was to characterize CRS rates after each talquetamab step-up dose in a real-world setting.

METHODS:

Patients with RRMM who completed the talquetamab once a week or once every 2 weeks step-up dosing schedule between September 2023 and November 2024 were identified via the institutional database. CRS rate after each talquetamab step-up dose was compared using the chi-square/Fisher’s exact test. The Kruskal-Wallis test was used to compare difference in median time to the CRS onset. Multivariate logistic regression analysis was performed to identify predictors of CRS.

RESULTS:

Fifty patients completed the talquetamab step-up dosing phase during the study period; CRS occurred at a rate of 80%. Pairwise comparisons revealed significant differences in CRS rates between the fourth dose (4%) and each of step-up dose 1 (28%, P = .014) and 2 (34%, P = .003). The only CRS event with fourth dose was grade 1. The median time to onset of first CRS did not differ significantly between step-up doses ( P = .441). Previous exposure to T-cell–redirecting therapy had no impact on CRS incidence (odds ratio: 0.20 [95% CI, 0.03 to 1.10]).

CONCLUSION:

Our findings suggested that the fourth talquetamab dose could be administered in outpatient settings given its high tolerability. The reduced hospitalization period for talquetamab step-up dosing could reduce health care expenses.

156

News (Medical) associated with Talquetamab

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

16 Jun 2026

·firstwordpharma.com

Biopharma bites: Germany rethinks rebate reform, Talvey's melanoma win and more from Takeda, Pelago

Germany might soften stance on variable drug discountsTalvey combo slashes progression risk in earlier-line myelomaTakeda touts more benefits for orexin sleep drugPelago snaps up fellow Swedish CRO in drug discovery push Germany might soften stance on variable drug discountsGermany's government is set to abandon plans for a controversial variable drug rebate system and replace it with fixed discounts, according to a government source cited in a Reuters report Monday.The original proposal, part of a broader healthcare reform package announced earlier this year, would have required drugmakers to offer rebates that fluctuated based on overall expenditures for drugs and on revenues of the healthcare system. Officials are now expected to introduce a fixed discount structure instead so that companies can plan ahead, the source said.The move follows intense pushback from industry. Eli Lilly recently cut in half a planned €2.3-billion ($2.7 billion) investment in a German manufacturing facility, while Boehringer Ingelheim reportedly scrapped more than €900 million ($1 billion) in planned domestic investments. Pfizer CEO Albert Bourla also raised concerns directly with Chancellor Friedrich Merz.The rebate debate is part of a wider effort by Health Minister Nina Warken to close a projected €20-billion ($23.2 billion) funding gap in Germany's public health insurance system and head off a hike in mandatory health insurance premiums. Last week, she insisted that pharma companies must contribute to cost-containment measures and argued that Germany was nevertheless still an attractive location for drugmakers.-Anna BratulicTalvey combo slashes progression risk in earlier-line myelomaJohnson & Johnson reported Phase III results showing that its GPRC5D-targeting bispecific antibody Talvey (talquetamab) can significantly improve outcomes when combined with Darzalex Faspro (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.In the MonumenTAL-3 study, Talvey plus Darzalex Faspro with pomalidomide reduced the risk of disease progression or death by up to 72% at a median follow-up of two years, compared to the standard regimen of Darzalex Faspro, pomalidomide and dexamethasone. Without pomalidomide, Talvey plus Darzalex Faspro cut the risk by 67%.Progression-free survival rates over the two-year follow-up reached 81.3% for the Talvey-Darzalex-pomalidomide regimen and 77.6% for the Talvey-Darzalex doublet, compared to 51.2% for the control arm. Overall survival rates at 24 months were 89.2% and 87.9%, respectively, versus 79.1% for standard therapy. Findings were reported at the European Hematology Association (EHA) conference and published in the NEJM.Talvey won US and EU approval in 2023 for heavily pretreated multiple myeloma. J&J said it has filed a supplemental BLA with the FDA, and a similar application with the EMA, seeking approval for Talvey plus Darzalex Faspro, with or without pomalidomide, for multiple myeloma patients following at least one prior therapy. -Anna BratulicTakeda touts more benefits for orexin sleep drugWith regulatory reviews already underway in the US, China and Japan, Takeda unveiled new Phase III data showing that its investigational orexin receptor 2 agonist oveporexton improved daily functioning, cognition and nighttime sleep in people with narcolepsy type 1 (NT1). The findings on secondary and exploratory measures, presented at the SLEEP 2026 conference, build on previously reported results from the FirstLight and RadiantLight studies that met all primary and secondary endpoints (see – KOL Views Q&A: Takeda's oveporexton is raising the bar for narcolepsy drugs, rival orexin agonists).Across all tested doses, Takeda said oveporexton significantly improved scores on the Functional Impacts of Narcolepsy Instrument (FINI), a measure spanning tiredness, cognition, cataplexy and social activities, as well as everyday activities and responsibilities. Most treated patients reached or exceeded published normative thresholds across the six FINI domains after 12 weeks of treatment.The company also highlighted improvements in cognitive symptoms. About 70% of patients on oveporexton reported no significant cognitive difficulties on the FINI cognitive function domain, compared to about 15% of placebo recipients. On exploratory nighttime symptoms, oveporexton improved sleep quality, with most patients reporting no hallucinations or sleep paralysis. Patients also experienced meaningful reductions in disturbed nighttime sleep from baseline.-Anna BratulicPelago snaps up fellow Swedish CRO in drug discovery pushPelago Bioscience, a contract research organisation (CRO) specialising in cell-based target engagement assays, has acquired fellow Swedish firm RG Discovery — founded by ex-AstraZeneca scientists — with the aim of creating a unified platform to accelerate drug discovery programmes across the full design-make-test-analyse cycle.The acquisition — financial terms of which were undisclosed — adds RG's medicinal chemistry, custom synthesis and integrated drug discovery expertise to Pelago's proprietary Cellular Thermal Shift Assay (CETSA)-based platform. The combined offering aims to eliminate inter-vendor handoffs that typically slow progression of molecules from hit identification through lead optimisation."We can offer customers a single scientific partner capable of designing and synthesising compounds, evaluating target engagement in living cells, and rapidly feeding those insights back into the next design cycle," said Michael Dabrowski, chief executive of Pelago.-Pavan Kamat

Clinical ResultPhase 3AcquisitionDrug Approval

15 Jun 2026

·www.biopharmadive.com

J&J multiple myeloma drug gains edge in earlier stage disease

Dive Brief:A combination of Johnson and Johnsons multiple myeloma drug Darzalex Faspro and immunotherapy Talvey significantly reduced the risk of disease progression or death in people with the blood cancer, opening the door to a potential label expansion for the latter.Data show that after two years, Talvey plus Darzalex Faspro, with or without the cancer medication Pomalyst, reduced the risk of death by as much as 53% when compared to the standard regimen in people with relapsed or refractory multiple myeloma. Additionally, the drug regimen reduced the risk of disease progression or death by up to 72%. The results were unveiled Saturday and presented at the European Hematology Association annual meeting, as well as published in The New England Journal of Medicine.J&J has been aiming to expand its blood cancer portfolio, and the latest results push forth Talveys prospects. While the drug is relatively new to its portfolio,J&J sees promise in its future.The company plans to expand its approval labeling in the U.S. and Europe.Dive Insight:Darzalex has long been a mainstay of multiple myeloma care, and quickly became a top-selling cancer drug for J&J with multiple label expansions.However, the company is seeking to expand its cancer offerings as it sees plummeting numbers for its autoimmune drug Stelara, which now faces biosimilar competition.Talvey has become a central player in that goal. The drug is a bispecific antibody approved in 2023 for the treatment of multiple myelomain adults who have received at least four prior lines of treatment. The drug is one of a growing class of medications called bispecific antibodies, binding to the CD3 protein on immune cells and also targeting a protein found on malignant blood plasma cells known as GPRC5D.While Talvey is a relatively younger product, the drug produced revenue of $463 million in 2025, a 61% increase from its first full year on market at $287 million. Meanwhile, J&Js oncology business increased overall by 22% from $20.8 billion in 2024 to $25.4 billion in 2025.J&J said the Phase 3 results are the first to demonstrate superior progression-free survival with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma.The company says it is now working with global regulatory authorities to expand Talveys use. '

Clinical ResultDrug ApprovalPhase 3ImmunotherapyADC

100 Deals associated with Talquetamab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Refractory Multiple Myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Relapse multiple myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Multiple Myeloma	United States	Janssen Biotech, Inc.	09 Aug 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Multiple Myeloma	Phase 2	United States	Janssen Research & Development LLC	01 Aug 2026
Recurrent Multiple Myeloma	Phase 2	United States	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Aug 2026
Residual Neoplasm	Phase 2	United States	Johnson & Johnson	21 Aug 2025
Peripheral Stem Cell Transplantation	Phase 2	United States	Janssen Scientific Affairs LLC	05 Jun 2025
Smoldering Multiple Myeloma	Phase 2	United States	Janssen Scientific Affairs LLC	04 Dec 2023
Extramedullary Disease in Multiple Myeloma	Phase 2	Spain	Janssen Pharmaceutica NV	21 Sep 2023
Hematologic Neoplasms	Phase 1	United States	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Belgium	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Netherlands	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Spain	Janssen Research & Development LLC	16 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05455320 (MonumenTAL-3, Pubmed \| N Engl J Med)	Phase 3	-	864	Talquetamab-Daratumumab-Pomalidomide	whjajsxemf(mnwnflidhs) = ucogmvvozj nksooysaja (haahrnyjju ) View more	Positive	13 Jun 2026
				Talquetamab-Daratumumab	whjajsxemf(mnwnflidhs) = abhwmdemak nksooysaja (haahrnyjju ) View more
ASCO2026	Not Applicable	Relapse multiple myeloma	402	Talquetamab	jktxwcraak(hpskfvsrnq) = nobmiafrhk qydankwiyb (cinxgybcrk ) View more	Positive	29 May 2026
				Teclistamab	jktxwcraak(hpskfvsrnq) = aykwaabhyf qydankwiyb (cinxgybcrk ) View more
ASCO2026	Not Applicable	Multiple Myeloma	542	Talquetamab+IVIG	psphzjwlcy(ycvwypsfzh) = bezdfuwikg fwqdoityfu (gjbmnplhaw ) View more	Positive	29 May 2026
				Talquetamab	psphzjwlcy(ycvwypsfzh) = bkdzhifxly fwqdoityfu (gjbmnplhaw ) View more
ASCO2026	Not Applicable	Relapse multiple myeloma	590	Talquetamab	jrrvngonzq(hfufspxcwy) = ER visits (HR = 0.716), anemia (HR = 0.915), sepsis (HR = 0.803), and pneumonia (HR = 0.641) were numerically lower in the talquetamab group but were not statistically significant (p > 0.05). Neutropenia (HR = 1.082), thrombocytopenia (HR = 1.301), and CRS (HR = 1.617) did not differ significantly (p > 0.05). Hospitalization, MM relapse, and neurotoxicity were not analyzable due to low events. gxegpmcnmw (osctpoudmh ) View more	Positive	29 May 2026
				Sequential BDT
ASCO2026	Not Applicable	Refractory Multiple Myeloma	1,941	Talquetamab	njiyvjctex(dpikgcdwpt) = TQ group had higher risk for developing CRS (RR 1.91 (1.34, 2.72), p<0.0001) szfwsfvruq (lefwzdlxze ) View more	Positive	29 May 2026
				Teclistamab
ASCO2026	Not Applicable	Refractory Multiple Myeloma	78	Talquetamab	vzjxxvsoth(aneonjxhni) = plldqpqofq sleaeqftrf (cbktqyeule, 0.27 - 0.4) View more	Positive	29 May 2026
				Elranatamab	vzjxxvsoth(aneonjxhni) = ynbtluphwr sleaeqftrf (cbktqyeule, 0.19 - 0.49) View more
NCT05972135 (ASCO2026)	Phase 2	Relapse multiple myeloma	50	TocilizumabTeclistamab + TocilizumabTeclistamab	qajvuaqonn(dtvggovqil) = cgwcidjggs noisvatgdn (giweqdbfvm ) View more	Positive	29 May 2026
				TocilizumabTalquetamab + TocilizumabTalquetamab	qajvuaqonn(dtvggovqil) = uokuxicqxu noisvatgdn (giweqdbfvm ) View more
NCT04586426 (RedirecTT-1, ASCO2026)	Phase 1/2	Relapse multiple myeloma	114	Talquetamab 0.8 mg/kg + Teclistamab 1.5 mg/kg Q2W	xqsndpxcwm(slwdfqbihg) = tdtlilpclh ircwbjtjdu (rxxsnbwqdp ) View more	Positive	29 May 2026
				Talquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kg	xqsndpxcwm(slwdfqbihg) = bhxltymyed ircwbjtjdu (rxxsnbwqdp ) View more
ASCO2026	Not Applicable	Multiple Myeloma BCMA	7,280	Ide-cel	klkoshfses(mrqmpjqowd) = jyzfhqwsau bgmopdntnm (exwbuopztu ) View more	Negative	29 May 2026
				Cilta-cel	klkoshfses(mrqmpjqowd) = ljfaajnvbd bgmopdntnm (exwbuopztu ) View more
NCT05455320 (MonumenTAL-3, EHA2026)	Phase 3	Relapse multiple myeloma Second line	864	Talquetamab+DARATUMUMAB+Pomalidomide	xrcwvlztac(iyqfbcohoe) = lqhjmowlrw xjggvalnrz (jnrsvigorm, 75.8 - 85.7) View more	Positive	12 May 2026
				Talquetamab+DARATUMUMAB	xrcwvlztac(iyqfbcohoe) = llacgsndbp xjggvalnrz (jnrsvigorm, 71.7 - 82.5) View more

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