- TALVEY® plus daratumumab with or without pomalidomide showed progression-free survival of up to 81.3% and overall survival of up to 89.2% at 24 months1
- MonumenTAL-3 is the third positive study in recent months from Johnson & Johnson’s bispecific portfolio and is the first Phase 3 study of a GPRC5D bispecific investigational combination1,2,3
- Results reinforce Johnson & Johnson’s leadership in multiple myeloma, advancing bispecific combinations earlier in the treatment journey, and expanding options to match the right treatment to the right patient and stage of disease1
BEERSE, BELGIUM, June 13, 2026 (GLOBE NEWSWIRE) — Johnson & Johnson today announced results from the investigational Phase 3 MonumenTAL-3 study.1 The results showed that TALVEY® (talquetamab), a GPRC5D bispecific antibody, in combination with daratumumab with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72.0%, and clinically meaningful reduction of up to 53.0% in the risk of death, compared to the standard regimen of daratumumab, pomalidomide, and dexamethasone (DPd) in patients with relapsed or refractory multiple myeloma (RRMM).1 Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.1
This is the first Phase 3 study to demonstrate superior PFS with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma, underscoring the potential of this regimen to advance bispecific combinations earlier in the treatment paradigm.1 Results were presented at the 2026 European Hematology Association (EHA) Annual Meeting (Abstract #S100), with simultaneous publication in The New England Journal of Medicine.1,4
Expert and company perspectives support bispecific combinations in earlier lines
“The impressive results from this study point to the promise of talquetamab plus daratumumab as a potential new bispecific combination for patients with relapsed or refractory multiple myeloma,” said Peter Voorhees, M.D., Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine.* “Talquetamab works with daratumumab in earlier lines—a critical time for treating patients with the most effective regimens.”
“Daratumumab-based regimens have transformed the treatment of multiple myeloma and remain a foundational therapy across all stages of disease. The MonumenTAL-3 study builds on this legacy, combining daratumumab with talquetamab, the first GPRC5D bispecific antibody, to further expand the effective options available to patients in the relapsed/refractory setting,” said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “These findings reflect Johnson & Johnson’s commitment to leveraging the power of our portfolio to advance novel combination regimens that address the evolving and highly heterogeneous needs of patients living with multiple myeloma.”
“The MonumenTAL-3 findings underscore our commitment to bringing bispecific combinations into earlier lines of therapy, building on the strength and breadth of Johnson & Johnson’s multiple myeloma portfolio,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson. “These results add to our growing body of evidence across bispecific antibodies and reinforce our strategy of advancing differentiated immunotherapies to better match the right therapy to the right patient at each stage of disease.”
Novel mechanism spares healthy immune cells
Talquetamab targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body).1 GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-Cells.1 Talquetamab works by targeting myeloma cells while largely sparing healthy B-cells.1 With daratumumab priming the immune system for enhanced talquetamab activity, the combination benefits from complementary mechanisms of action, supporting the potential effectiveness of this approach in multiple myeloma.1,5,6
Phase 3 MonumenTAL-3 study results
The MonumenTAL-3 study evaluated talquetamab with daratumumab subcutaneous (SC) or talquetamab with daratumumab SC (Tal-D) and pomalidomide (Tal-DP) compared to DPd in patients with RRMM who have received at least one prior line of therapy.1 At a median follow-up of two years (24.6 months), results showed significant improvement in PFS for Tal-DP (hazard ratio [HR], 0.28; 95% confidence interval [CI], 0.20-0.40; p<0.0001) and Tal-D (HR, 0.33; 95% CI, 0.24-0.46; p<0.0001).1 At 24 months, Tal-DP showed a PFS rate of 81.3% and Tal-D showed a PFS rate of 77.6%.1 All participants (N=864) were previously exposed to lenalidomide and a proteasome inhibitor and received at least one prior line of therapy.1 Most patients enrolled were refractory to lenalidomide (85.1%) and their last line of therapy (93.4%), and some were exposed to an anti-CD38 antibody (11.8%).4
Statistically significant improvements compared to DPd were observed across key secondary endpoints of overall response rate (ORR), complete response or better (≥CR), and minimal residual disease (MRD)-negative ≥CR (10-5, next-generation sequencing [NGS]) for Tal-DP and Tal-D.1 ORRs (88.2%, 88.5%, 77.6%), ≥CR rates (71.1%, 68.9%, 34.5%) and MRD-negative ≥CR rates (52.3%, 46.3%, 15.9%) were significantly higher for Tal-DP and Tal-D vs DPd, respectively, after two years median follow-up.1 Clinically meaningful improvement in OS was shown with Tal-DP (HR, 0.47; 95% CI, 0.30-0.73, p=0.0006) and Tal-D (HR, 0.51; 95% CI, 0.33-0.78, p=0.0015) vs DPd.1 At 24 months, Tal-DP delivered an OS rate of 89.2% and Tal-D delivered an OS rate of 87.9%.1
The overall safety profiles for the talquetamab plus daratumumab SC treatment arms were consistent with the known safety profiles of each monotherapy, and a reduced risk of severe infections were observed in the Tal-D arm compared to the standard of care.1 Overall, rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable across treatment arms (94.9% with Tal‑DP, 74.8% with Tal‑D, and 91.5% with DPd).4 Infections occurred at rates of 87.3% (Tal‑DP), 84.3% (Tal‑D), and 83.0% (DPd).1 When analysing severe infections, Tal-D had the lowest rate of Grade 3/4 infections (29.2%), followed by Tal-DP (37.7%), and DPd (42.2%).1 There were some instances of Grade 5 adverse events (AEs) across the entire population of the study; the Tal-DP arm saw the fewest (1.8%), followed by Tal-D (4.0%) and DPd (4.6%), with approximately 0.7% (Tal-DP), 1.5% (Tal-D), and 1.8% (DPd) due to infections.4 Treatment discontinuations due to AEs occurred in 10.5% of Tal‑DP, 8.0% of Tal‑D, and 6.7% of DPd patients.1 At data cutoff, 70.3% (Tal-DP), 69.7% (Tal-D), and 47.3% (DPd) of patients remained on study treatment.1 Cytokine release syndrome occurred in 67.8% (Tal‑DP) and 58.4% (Tal‑D) of patients and was predominantly Grade 1–2, while immune effector cell‑associated neurotoxicity syndrome was infrequent (2.9% and 1.8% respectively), with no Grade ≥4 events reported.1 Across Tal-DP, Tal-D and DPd, respectively, taste change (72.8%, 74.8%, 3.9%) and weight loss (45.7%, 38.3%, 7.4%) AEs along with ataxia/balance disorders (Grade 1-2: 11.6%, 10.2%, 0.4%; Grade 3: 2.9%, 2.2%, 0.0%) were primarily low grade and rarely led to talquetamab discontinuation, supporting the manageable safety profile.1,4
Based on these results, Johnson & Johnson is working with regulatory bodies globally to bring the benefits of talquetamab plus daratumumab SC with or without pomalidomide to eligible patients as quickly as possible. On 31 March 2026, the Company submitted a type II variation to the European Medicines Agency (EMA) for the use of talquetamab in combination with daratumumab, or in combination with daratumumab and pomalidomide, for the treatment of adult patients with RRMM who have received at least one prior therapy.
About the MonumentTAL-3 study
The MonumenTAL-3 (NCT05455320) study is an ongoing Phase 3 study of talquetamab in combination with daratumumab subcutaneous (SC) with or without pomalidomide compared to daratumumab SC combined with pomalidomide and dexamethasone in patients with relapsed of refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.7 The primary endpoint is progression-free survival (PFS) and secondary endpoints include overall response rate (ORR), complete response or better (≥CR), minimal residual disease (MRD)-negative ≥CR (10-5 by next-generation sequencing), overall survival (OS) and safety.7 The MonumenTAL-3 study is a part of the MonumenTAL clinical program, which includes exploring the potential of talquetamab as a combination regimen.7
About Talquetamab
Talquetamab received conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.8 The U.S. FDA also granted talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.9
Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors.8 To date, more than 11,000 patients have been treated with talquetamab worldwide.10
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the Summary of Product Characteristics. In line with the European Medicine Agency’s regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring.
▼ In line with EMA regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring.8
About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.
In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide.11 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.12,13 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.13,14 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.13
CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.13,15 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.13 Daratumumab may also have an effect on normal cells.13 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.16,17,18,19,20,21,22,23,24,25
For further information on daratumumab, please see the Summary of Product Characteristics at:
https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf.
About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.26,27 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.28,29 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.30 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.31,32,33 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.34
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/innovativemedicine/emea/. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of talquetamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent
*Peter Voorhees, M.D., Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
END
1 Voorhees P, et al. Phase 3 randomized study of talquetamab (TAL) plus daratumumab (DARA) ± pomalidomide (POM) vs DARA plus DOM ad dexamethasone (DPD) in relapsed/refractory multiple myeloma (RRMM): MonumenTAL-3. Presented at: 2026 European Hematology Association Congress; June 13, 2026; Stockholm.
2 Touzeau C, et al. Teclistamab monotherapy in multiple myeloma with 1–3 prior lines of therapy. Presented at: 2026 American Society of Clinical Oncology (ASCO); May 29, 2026; Chicago.
3 Mateos MV, et al. Phase 3 Randomized Study of Teclistamab plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone with either Pomalidomide or Bortezomib (DPd/DVd) in patients (pts) with Relapsed Refractory Multiple Myeloma (RRMM): Results of the MajesTEC-3 Study. Oral Presentation #06. American Society of Hematology (ASH) Annual Meeting; 06-09 December, 2025.
4 Mina R, et al. Talquetamab–daratumumab in relapsed or refractory myeloma. N Engl J Med. 13 June 2026.
5 Chari A, et al. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025;146(24).
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7 ClinicalTrials.gov. MonumenTAL‑3: Study of talquetamab in combination with daratumumab ± pomalidomide versus daratumumab + pomalidomide + dexamethasone in relapsed or refractory multiple myeloma (NCT05455320). Available at: https://clinicaltrials.gov/study/NCT05455320. Last accessed: June 2026
8 European Medicines Agency. TALVEY Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/talvey-epar-product-information_en.pdf. Last accessed: June 2026.
9 FDA. FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma. Last accessed: June 2026
10 J&J Data on File. Number of Patients Treated with TALVEY® worldwide as of March 2026.
11 J&J Data on File. Number of Patients Treated with DARZALEX® Worldwide as of December 2025.
12 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: http://www.businesswire.com/news/home/20200604005487/en/European-Commission-GrantsMarketingAuthorisation-for-DARZALEX%C2%AE%E2%96%BC-daratumumab-SubcutaneousFormulation-for-all-CurrentlyApproved-Daratumumab-Intravenous-Formulation-Indications. Last accessed: June 2026.
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14 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026.
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16 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38.
17 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115.
18 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141.
19 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812.
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22 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884.
23 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518.
24 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024.
25 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313.
26 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.
27 Myeloma UK. What is myeloma Available at: https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma/. Last accessed: June 2026.
28 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668.
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31 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.
32 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23.
33 McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111.
34 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Last accessed: June 2026.
CP-585393
June 2026
CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com
