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 Research & Development LLCJanssen-Cilag International NV

+ [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), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Conditional marketing approval (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

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 Mar 2027

Sponsor / Collaborator

University of Arkansas Fort Smith

[+1]

KCT0012388

/ Not yet recruitingPhase 2IIT

A Multicenter, Phase 2 Study of Talquetamab Added to Lenalidomide Maintenance for MRD-Positive Multiple Myeloma (TAL-MRD, Talquetamab Added to Lenalidomide for MRD-positive MM)

Start Date01 Sep 2026

Sponsor / Collaborator

Chonnam National University Hwasun Hospital

100 Clinical Results associated with Talquetamab

100 Translational Medicine associated with Talquetamab

100 Patents (Medical) associated with Talquetamab

151

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 ; Yang, Chelsey ; Patel, Neel ; Jiao, Tianze ; Liu, Yi-Hsuan ; Wang, Jiamin ; Grajales-Cruz, Ariel F. ; Lee, Hans C. ; Zhang, Xinke ; 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 Oct 2026·EUROPEAN JOURNAL OF HAEMATOLOGY

Condensed vs. Standard Step‐Up Dosing Schedule of Talquetamab in Relapsed/Refractory Multiple Myeloma

Article

Author: Khouri, Jack ; Kissam, Jonathan ; Hansen, Doris K. ; Gonzalez, Rebecca ; Rudoni, Joslyn ; Dominick, Anthony ; Mahmoudjafari, Zahra ; Davis, James A. ; Sborov, Douglas W. ; Rice, Mikhaila ; Granger, Katelynn ; Warrick, Matthew ; Grajales‐Cruz, Ariel ; Julian, Kelley ; Elsey, Grace ; Atrash, Shebli ; Snyder, Jordan ; McElwee, Jessica ; Vince, Megan ; Nachar, Victoria R. ; Ahmed, Iman ; Moore, Donald C. ; Bryan, Baylee ; Cahoon, Christopher ; Pianko, Matthew

ABSTRACT:

Objective:

To compare the incidence and severity of cytokine release syndrome (CRS) and immune effector cell‐associated neurotoxicity syndrome (ICANS) between two different step‐up dosing (SUD) schedules with talquetamab, the standard SUD schedule of Days 1, 4, 7, and 10 and a condensed SUD schedule of Days 1, 3, 5, and 7.

Methods:

We conducted a multicenter retrospective study across seven academic medical centers in the United States and included patients who received talquetamab for the treatment of relapsed/refractory multiple myeloma. The incidence and grade of severity of CRS and ICANS were compared between patients receiving the standard SUD schedule and the condensed SUD schedule.

Results:

A total of 144 patients were included in our analysis; 33 received the standard SUD schedule and 111 received the condensed SUD schedule. The incidence of CRS (76% vs. 56%; p = 0.101) and ICANS (9% vs. 16%; p = 0.41) was similar between the standard and condensed SUD cohorts. There was no significant difference in the severity of CRS and ICANS between both cohorts.

Conclusion:

Shortening the interval between talquetamab SUDs appears feasible and well‐tolerated in routine clinical practice.

08 Sep 2026·Blood Advances

Real-world outcomes with BCMA- and GPRC5D-targeting bispecific antibodies in plasma cell leukemia

Article

Author: Shune, Leyla ; Khouri, Jack ; Banerjee, Rahul ; Gaballa, Mahmoud R. ; Rossi, Adriana ; Abid, Muhammad Bilal ; De Menezes Silva Corraes, Andre ; Janakiram, Murali ; Patel, Krina K. ; Grajales-Cruz, Ariel ; Pasvolsky, Oren ; Bal, Susan ; Fogel, Lindsay ; Harada, Ken ; Atrash, Shebli ; Kaur, Gurbakhash ; Anderson, Larry D. ; Richards, Tiffany ; Shain, Kenneth ; Sborov, Douglas W. ; Richard, Shambavi ; Sannareddy, Aishwarya ; Davis, James ; Green, Kimberly ; Biran, Noa ; Herr, Megan ; Hosoya, Hitomi ; De Avila, Gabriel ; Zanwar, Saurabh S. ; Ali, Hossam M. ; Rana, Masooma ; Castaneda-Puglianini, Omar ; Lin, Yi ; Mikkilineni, Lekha ; Ouchveridze, Evguenia ; Lee, Hans C. ; Portuguese, Andrew J. ; Ferreri, Christopher ; Goel, Utkarsh ; Ye, Jing Christine ; Dima, Danai ; Borogovac, Azra ; Sidana, Surbhi ; Zolotov, Eli ; Julian, Kelley ; Afrough, Aimaz ; Raza, Shahzad ; DeJarnette, Shaun ; Hansen, Doris K. ; Hassan, Hamza ; Voorhees, Peter M.

Abstract:

Patients with plasma cell leukemia (PCL) are generally excluded from pivotal T-cell–redirecting bispecific antibody (BsAb) trials. We evaluated real-world outcomes in a multicenter retrospective study of 122 patients with primary or secondary PCL across 15 academic centers, categorized as active (≥5% circulating plasma cells within 30 days before BsAb initiation) or historical. Patients received teclistamab (37%), elranatamab (11%), talquetamab as a line of therapy (Tal LOT, 42%), or talquetamab as bridging to CAR T-cell therapy (Tal Bridge, 11%). Cytokine release syndrome was grade 1 to 2 in 56% and grade 3 to 4 in 4% of patients, whereas neurotoxicity was grade 1 to 2 in 16% and grade 3 to 4 in 5% of patients. The overall response rate was 55%, including 61% with Tal LOT, 58% with Tal Bridge, 46% with elranatamab, and 33% with teclistamab. With a median follow-up of 8.3 months, talquetamab demonstrated superior survival. Tal LOT showed a median progression-free survival (mPFS) of 5.5 months and a median overall survival (mOS) of 11.5 months, and both were unreached in the Tal Bridge cohort. In contrast, teclistamab and elranatamab showed a mPFS values of 1.2 and 1.6 months and mOS values of 8.1 and 3.6 months, respectively (P = .007, P = .023). In active PCL, Tal LOT achieved mPFS/mOS of 6.9/12.2 months vs 0.7/1.4 months with teclistamab and 1.0/3.1 months with elranatamab, respectively (P< .001, P = .002). Multivariable analysis associated active PCL with worse survival and Tal LOT with improved outcomes. BsAbs were well tolerated in PCL, with talquetamab showing superior outcomes compared with B-cell maturation antigen–directed BsAbs.

178

News (Medical) associated with Talquetamab

23 Sep 2026

·www.biospace.com

New model-based analysis further supports the potential of TECVAYLI®▼ (teclistamab) plus daratumumab to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma

Analysis showed ~87% of patients treated with TECVAYLI ® ▼ plus daratumumab as early as second line were estimated to have comparable mortality risk to the general population 1 A separate analysis shows the survival benefit was driven by a 90% reduction in the risk of multiple myeloma progression versus standard of care, with no significant difference in rates of non-relapse mortality 2 BEERSE, Belgium, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson, a worldwide leader in multiple myeloma, today announced new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI ® (teclistamab) plus daratumumab in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy. In an analysis to be presented in Abstract #OA-58, statistical modelling estimated that more than 85% of patients treated with teclistamab plus daratumumab may experience a mortality risk and projected life expectancy similar to an age-matched general population. 1 The analysis used a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from MajesTEC-3. 1 Modelling further predicted that median OS with teclistamab plus daratumumab would be nearly four-fold longer than with the standard-of-care comparator in the study, daratumumab and dexamethasone with either pomalidomide or bortezomib (DPd/DVd). 1 These data help to illustrate to what extent treatment with teclistamab plus daratumumab as early as second line may reshape survival expectations in multiple myeloma. Post-hoc analysis provides insight into the survival benefit In the MajesTEC-3 study, teclistamab plus daratumumab significantly improved OS versus SOC, with an estimated 83% of patients alive at three years. 2 A post hoc analysis (Abstract #OA-49) showed that teclistamab plus daratumumab reduced the risk of cumulative incidence of disease progression by 90% versus SOC, with no significant difference in non-relapse mortality over time between the treatment arms. 2 These data will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting. 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. 3 Expert and company perspectives emphasise the potential for durable, long-term disease control “These findings underscore how consequential treatment choice at first relapse can be in shaping a patient’s long-term trajectory,” said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham.* “The sustained disease control observed with teclistamab plus daratumumab is changing expectations for what treatment can achieve in relapsed or refractory multiple myeloma, moving beyond just delaying the next relapse toward the possibility of durable long-term disease control.” “Seeing projected life expectancy for patients with relapsed or refractory multiple myeloma potentially approach that of the general population is an exciting and hopeful signal of what may be possible with teclistamab plus daratumumab,” said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Alongside the growing body of positive clinical evidence, these analyses reinforce our convictions that this combination offers a new standard of care – one where outcomes once considered difficult to imagine could become increasingly achievable for patients.” “The continued analyses of the MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this disease is no longer defined as incurable.” Model-based analysis projects potential long-term survival outcomes The MajesTEC-3 study evaluated teclistamab plus daratumumab versus investigator’s choice of DPd/DVd in patients with RRMM who had received 1-3 prior lines of therapy. In this analysis, a relative survival MCM was applied to patients treated with teclistamab plus daratumumab (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general population. 1 Best-fit models estimated cure fractions of 86.6% (95% confidence interval [CI], 81–91) for OS with the combination, compared with 0% (95% CI, 0–53) with DPd/DVd, with substantially greater uncertainty in the DPd/DVd estimates. 1 Model projected remaining life expectancy was 18.5 years with the teclistamab plus daratumumab combination, nearly four times the 4.9 years projected with DPd/DVd and approaching 21.1 years for the matched general population. 1 Reduced disease progression drives survival benefit A separate post hoc analysis provided further insight into the survival benefit observed in MajesTEC-3. At 36 months, the cumulative incidence of disease progression was 8.7% with teclistamab plus daratumumab versus 62.1% with DPd/DVd, representing a 90% reduction in the risk of disease progression (sub-distribution hazard ratio [sHR]=0.10; 95% CI, 0.07–0.16; p <0.0001). 2 The 36-month OS rate was 83.3% versus 65.0%, respectively (HR=0.46; 95% CI, 0.32–0.65; p <0.0001). 2 There was no significant difference in non-relapse mortality between treatment groups, with 36-month rates of 10.2% with teclistamab plus daratumumab and 9.0% with DPd/DVd (sHR=1.16; 95% CI, 0.69–1.98; p =0.5668). 2 No statistically significant difference in overall survival was observed between the treatment groups during the first 10 months (HR=1.08; 95% CI, 0.64–1.81). 2 After 10 months, overall survival favoured teclistamab plus daratumumab, with a 78% reduction in the risk of death compared with DPd/DVd (HR=0.22; 95% CI, 0.13–0.38). 2 A prespecified restricted mean survival time analysis also supported a significant overall survival benefit, with a difference of 2.15 months during the period analysed ( p =0.0088). 2 Together, these analyses provide complementary evidence supporting the long-term benefit observed with teclistamab plus daratumumab. While the MCM analysis suggests the potential for highly durable disease control to extend OS for patients with multiple myeloma relative to the general population, the competing risk analysis helps explain these outcomes by demonstrating a profound reduction in disease progression without a significant increase in non-relapse mortality. 1,2 MajesTEC-3 is ongoing, and continued follow-up will assess whether observed outcomes confirm these model-based predictions. 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 one to three prior lines of therapy. 3, 4 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. 4 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 4 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. 5 In August 2026, the EC approved teclistamab in combination with daratumumab for the treatment of patients with RRMM who have received at least one prior therapy, providing a treatment option as early as second line. 6 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 7 , 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. 7 Teclistamab is currently being evaluated in several combination studies. 9 ,1 0 ,1 1 ,1 2 To date, more than 30,700 patients have been treated worldwide with teclistamab. 1 3 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. 7 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. 1 4 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 1 5,16 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. 1 5 , 1 7 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 1 5 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 1 5 , 17 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 18 Daratumumab may also have an effect on normal cells. 1 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. 19,20,21,22,23,24,25,26,27,28 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. 29,30 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. 3 1 ,3 2 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. 3 3 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 3 4,35,36 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 7 About Johnson & Johnson’s Multiple Myeloma Portfolio Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies. Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses. Through ongoing research and a robust clinical program, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured. 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 *Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. CP-604037 September 2026 END References: 1 van den Donk Niels., et al. Projecting Functional Cure in Patients with Relapsed/Refractory Multiple Myeloma(RRMM) in the MajesTEC-3 Study ofTeclistamab-Daratumumab (Tec-Dara) Usinga Mixture Cure Model . Presented at: 2026 International Myeloma Society Meeting; 23 September; Glasgow. 2 Costa L., et al. Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab (Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis . Presented at: 2026 International Myeloma Society Meeting; 23 September; Glasgow. 3 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: September 2026. 4 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: September 2026. 5 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: September 2026. 6 Johnson & Johnson.com. European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. Available at: . Last accessed: September 2026. 7 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: September 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: September 2026. 1 0 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: September 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: September 2026. 1 2 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: September 2026. 1 3 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of June 2026. 1 4 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of August 2026. 1 5 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: September 2026. 1 6 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: September 2026. 1 7 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 18 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. 19 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. 2 0 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. 2 1 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. 2 2 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 3 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 4 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 2 5 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 6 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 7 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. 28 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. 29 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 3 0 Myeloma UK. What is myeloma? Available at: . Last accessed: September 2026. 3 1 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 3 2 Mayo Clinic. Multiple Myeloma. Available at: 20353378 . Last accessed: September 2026. 3 3 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2024, by Country. Multiple Myeloma. Available at: . Last accessed: September 2026. 3 4 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. 3 5 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. 3 6 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. 3 7 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: September 2026. CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investorcontact: JessMargevich investor-relations@its.jnj.com

Clinical ResultPhase 3Drug ApprovalLicense out/inImmunotherapy

18 Sep 2026

·www.biospace.com

CHMP recommends approval of Johnson & Johnson’s TECVAYLI®▼ (teclistamab) in relapsed/refractory multiple myeloma after at least one prior therapy

CHMP recommendation follows positive Phase 3 study results, marking the second Phase 3 study to demonstrate benefit with a TECVAYLI ® -based regimen in the second-line setting 1 ,2 Results demonstrated significantly improved progression-free and overall survival versus standard of care, reinforcing TECVAYLI ® ’s potential for patients with relapsed/refractory multiple myeloma (RRMM) 1 BEERSE, BELGIUM, Sept. 18, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson, a worldwide leader in multiple myeloma, 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) for the treatment of adult patients with RRMM who have received at least one prior therapy. Addressing evolving treatment needs in relapsed or refractory multiple myeloma Many patients with multiple myeloma relapse after first-line therapy, and treatment options are increasingly limited once the disease becomes refractory to established treatment classes such as anti-CD38 monoclonal antibodies and lenalidomide. 3 , 4 Despite recent advances, there remains a critical need for additional effective immunotherapy options, particularly in earlier lines of therapy. 3 , 4 Expert and company perspectives support teclistamab use earlier in the treatment pathway “Relapsed or refractory multiple myeloma remains a complex disease, with diverse and evolving patient needs,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “This positive CHMP opinion reflects the importance of teclistamab in multiple myeloma and further reinforces its potential as a foundational immunotherapy after first-line treatment. By providing steroid-sparing combination and monotherapy regimens, teclistamab has the potential to expand the choices for patients living with the disease and redefine what’s possible in multiple myeloma.” “Today’s recommendation reflects our longstanding commitment to transforming outcomes for patients with multiple myeloma by advancing innovative therapies, such as teclistamab, into earlier lines of treatment, where they have the greatest potential to change the trajectory of the disease,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “By investing across the treatment continuum, from established foundations of care to novel immunotherapies, we remain focused on delivering differentiated treatment options that address patients’ diverse needs at every stage of their disease, all with the goal of improving long-term outcomes and, where possible, moving people closer to durable remission and, ultimately, cure.” Teclistamab monotherapy demonstrated significant improvements in progression-free and overall survival compared to standard of care The CHMP recommendation is supported by data from the Phase 3 MajesTEC-9 study ( NCT05572515 ), evaluating the efficacy and safety of teclistamab, a bispecific T-cell engager, as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. 5 Significant improvements were observed in both progression-free survival (PFS) and overall survival (OS). 1 Treatment with teclistamab demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; p <0.001) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83; p = 0.002) compared to standard of care. 1 Additionally, all key secondary endpoints showed significant improvement with teclistamab versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR, 65.9% vs. 16.8%; p <0.001). 1 Safety pro with that established in prior studies The safety pro teclistamab in the study was consistent with its known safety profile. 6 The median duration of treatment on teclistamab was almost two times longer than standard of care (13.1 months vs. 7.0 months), with similar rates of adverse events (AEs) observed between teclistamab and standard of care (99.7% vs. 97.9%). 1 Grade 3/4 AEs occurred in 84.9% of teclistamab recipients versus 76.3% of PVd or Kd recipients, while Grade 5 AEs occurred in 6.5% versus 3.5%, respectively. 1 Infections were more frequent with teclistamab than with standard of care (Grade 3/4, 41.6% vs. 29.0%), and rates of Grade 3 or higher infections decreased over time. 1 This regulatory milestone builds on the recent European Commission approval of 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, based on the results of the MajesTEC-3 study published in The New England Journal of Medicine . 7 Together, these two Phase 3 studies help establish the potential of teclistamab-based regimens as an important treatment option across a broad second-line population. 7 About the MajesTEC-9 study MajesTEC-9 ( NCT05572515 ) is an ongoing, randomised Phase 3 study comparing teclistamab monotherapy with pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines including lenalidomide and an anti-CD38 monoclonal antibody. 5 The primary endpoint is progression-free survival (PFS); secondary endpoints include complete response or better (≥CR), duration of response (DoR), overall survival (OS), safety and patient-reported outcomes. 1 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. 8 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 9 In August 2026, the EC also approved a Type II variation application for teclistamab in combination with daratumumab as early as second line for RRMM. 7 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 6 , 10 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. 6 Teclistamab is currently being evaluated in several combination studies. 11,12,13,14 To date, more than 30,700 patients have been treated worldwide with teclistamab. 1 5 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. 6 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. 1 6 , 1 7 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. 1 8 , 1 9 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. 20 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 21,22,23 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. 2 4 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-9 Phase 3 clinical trial TECVAYLI Teclistamab Teclistamab monotherapy 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 BCMA-targeted bispecific therapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment References: 1 Touzeau C, et al. Teclistamab monotherapy in multiple myeloma with 1–3 prior lines of therapy. N Engl J Med. 2026;395(5):440-453. 2 Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2025;394(8):739-752. 3 Johnson & Johnson.com. TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. Available at: . Last accessed: September 2026. 4 Ramasamy K, et al. Real-World Treatment Patterns and Clinical Outcomes in Patients With Multiple Myeloma Previously Treated With Lenalidomide and an Anti-CD38 Monoclonal Antibody. Clin Lymphoma Myeloma Leuk. 2025 May;25(5):337-348.e2. 5 ClinicalTrials.gov. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9). Available at: . Last accessed: September 2026. 6 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: September 2026. 7 Johnson & Johnson.com. European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. Available at: . Last accessed: September 2026. 8 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: September 2026. 9 Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: September 2026. 10 Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):494-505. 11 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: September 2026. 12 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: September 2026. 13 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: September 2026. 14 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: September 2026. 15 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of July 2026. 16 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 17 Myeloma UK. What is myeloma? Available at: . Last accessed: September 2026. 18 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 19 Mayo Clinic. Multiple Myeloma. Available at: . Last accessed: September 2026. 20 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: . Last accessed: September 2026. 21 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. 2 2 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. 2 3 McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111. 2 4 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: September 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 ResultImmunotherapyDrug Approval

17 Sep 2026

·www.fiercebiotech.com

GSK doubles down on Chimagen with $750M multiple myeloma wager

GSK has bet up to $750 million on a Chimagen Biosciences trispecific T-cell engager (TCE), positioning the Big Pharma to start phase 1 development of the multiple myeloma drug candidate next year. The deal comes two years after GSK paid China’s Chimagen $300 million upfront for a trispecific lupus prospect. Neither party has disclosed the targets of the new candidate, but GSK shed some light on the rationale for the trispecific design. TCEs have shown “transformational efficacy in multiple myeloma but have been associated with difficult tolerability profiles,” GSK said. Chimagen designed its candidate to overcome the limitations of existing TCEs by targeting two tumor-associated antigens while also binding to T cells. The FDA has approved several bispecific TCEs in multiple myeloma. Johnson & Johnson's Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic all engage BCMA on cancer cells and CD3 on T cells. J&J’s Talvey is a GPRC5DxCD3 bispecific. All four TCEs carry boxed warnings for cytokine release syndrome and neurologic toxicity. GSK licensed the Chimagen candidate believing it could trigger deeper, more durable responses than existing TCEs while having improved tolerability. A product with the target profile may be used more broadly than existing TCEs and be adopted earlier in the treatment pathway. The current TCEs are approved for monotherapy use in patients who have received at least four prior lines of therapy. Multiple companies have identified the trispecific design as a way to create better TCEs for multiple myeloma. Last year, AbbVie paid Ichnos Glenmark Innovation $700 million upfront for a trispecific antibody that targets CD38, BCMA and CD3. The deal represented a big bet that targeting CD38, as well as BCMA, will make the drug candidate more potent than the bispecifics Tecvayli, Elrexfio and Lynozyfic. J&J is also investing in trispecifics, launching phase 3 trials of a drug candidate that binds CD3 on T cells and BCMA and GPRC5D on myeloma cells. The company sees the trispecific design as a way to achieve a more sustained immune response in recurrent multiple myeloma. J&J’s phase 3 program includes a trial comparing the trispecific to a BCMAxCD3 TCE. While trispecifics are promising, the modality can be complex to manufacture, suffer pharmacokinetic limitations and cause immunogenicity-related toxicities. Chimagen’s efforts to overcome the challenges have spawned a pipeline of tri- and multispecific programs in immunology and oncology. The content above comes from the network. if any infringement, please contact us to modify.

100 Deals associated with Talquetamab

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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
Residual Neoplasm	Phase 3	-	Johnson & Johnson	01 Sep 2026
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
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

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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	hdzxexrckm(lanfihuiei) = mlqpxhvwfl usvremoova (sxvckxwnut ) View more	Positive	13 Aug 2026
				Talquetamab-Daratumumab	hdzxexrckm(lanfihuiei) = jnhwpsbxcv usvremoova (sxvckxwnut ) View more
NCT04586426 (RedirecTT-1, ASCO2026)	Phase 1/2	Relapse multiple myeloma	114	Talquetamab 0.8 mg/kg + Teclistamab 1.5 mg/kg Q2W	ojntxzipxu(rtaixmsvyg) = qbveibhshy mmpjwwocwq (nrzziqjicu ) View more	Positive	29 May 2026
				Talquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kg	ojntxzipxu(rtaixmsvyg) = tpugudezxj mmpjwwocwq (nrzziqjicu ) View more
ASCO2026	Not Applicable	Relapse multiple myeloma	402	Talquetamab	dvnltdporl(zmswshusvq) = httagnetmn byeoioquwc (vvhjvrakbv ) View more	Positive	29 May 2026
				Teclistamab	dvnltdporl(zmswshusvq) = kmdptxbwtc byeoioquwc (vvhjvrakbv ) View more
ASCO2026	Not Applicable	Relapse multiple myeloma	590	Talquetamab	ywyzjpxlys(bcubmozhxy) = 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. qicbeuxtwh (awraajvcer ) View more	Positive	29 May 2026
				Sequential BDT
ASCO2026	Not Applicable	Refractory Multiple Myeloma	1,941	Talquetamab	kgkqxgiyvl(cnnwhfqtmw) = TQ group had higher risk for developing CRS (RR 1.91 (1.34, 2.72), p<0.0001) vuhxtkrgqm (xcrydjzxer ) View more	Positive	29 May 2026
				Teclistamab
NCT05972135 (ASCO2026)	Phase 2	Relapse multiple myeloma	50	TocilizumabTeclistamab + TocilizumabTeclistamab	orlijtdhzx(hwklxlhyxi) = drnzxntsos arabzxunxj (bxsuhizkij ) View more	Positive	29 May 2026
				TocilizumabTalquetamab + TocilizumabTalquetamab	orlijtdhzx(hwklxlhyxi) = nhudwnzlpl arabzxunxj (bxsuhizkij ) View more
ASCO2026	Not Applicable	Multiple Myeloma	542	Talquetamab+IVIG	blfopgezfa(lvregnrsrg) = jmnnszcvsr qdvixlaxiz (rotaspgpqa ) View more	Positive	29 May 2026
				Talquetamab	blfopgezfa(lvregnrsrg) = whqisggnxq qdvixlaxiz (rotaspgpqa ) View more
ASCO2026	Not Applicable	Refractory Multiple Myeloma	78	Talquetamab	wwjquaslju(gdrqpshwtr) = jtzzdaegxs jkejgjzojm (pnqipbnjxe, 0.27 - 0.4) View more	Positive	29 May 2026
				Elranatamab	wwjquaslju(gdrqpshwtr) = meruevdzqf jkejgjzojm (pnqipbnjxe, 0.19 - 0.49) View more
ASCO2026	Not Applicable	Multiple Myeloma BCMA	7,280	Ide-cel	wluhqhsjpn(dxntxdpyzt) = pubpafwazd tnwmltonnk (ocoeexfzja ) View more	Negative	29 May 2026
				Cilta-cel	wluhqhsjpn(dxntxdpyzt) = ttgxjsuqcv tnwmltonnk (ocoeexfzja ) View more
EHA2026	Not Applicable	Relapse multiple myeloma	41	teclistamabtalquetamabelranatamab + teclistamabtalquetamabelranatamab + teclistamabtalquetamabelranatamab (pre-VW)	nfczmejwei(vvxhkgkmms) = tltmwhelfi hjdtlkhfdw (wosqqkrwps ) View more	Positive	12 May 2026
				teclistamabtalquetamabelranatamab + teclistamabtalquetamabelranatamab + teclistamabtalquetamabelranatamab (post-VW)	nfczmejwei(vvxhkgkmms) = xdbfvyzksp hjdtlkhfdw (wosqqkrwps ) View more

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