globenewswire news

• 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 population¹
  
  
• 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 mortality²
  
  

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.^9,10,11,12

To date, more than 30,700 patients have been treated worldwide with teclistamab.¹³

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: https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf. 

▼ 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.¹⁴ Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.^15,16  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.^15,17 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE^® drug delivery technology.¹⁵

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.^15,17 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.¹⁸ Daratumumab may also have an effect on normal cells.¹⁵  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: 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.^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.^31,32 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.³³ Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.^34,35,36 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.³⁷

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 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 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 http://www.sec.gov/, http://www.jnj.com/, www.investor.jnj.com 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: https://www.nejm.org/doi/full/10.1056/NEJMoa2514663. 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: https://clinicaltrials.gov/study/NCT05083169. Last accessed: September 2026.
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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: https://www.jnj.com/innovativemedicine/emea/media-center/press-releases/european-commission-approves-johnson-johnsons-tecvayli-teclistamab-plus-daratumumab-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care. Last accessed: September 2026.
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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: https://clinicaltrials.gov/ct2/show/NCT04108195. Last accessed: September 2026.
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¹³ J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of June 2026.
¹⁴ J&J Data on File. Number of Patients Treated with DARZALEX^® Worldwide as of August 2026.
¹⁵ European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf. Last accessed: September 2026.
¹⁶ 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: September 2026.
¹⁷ 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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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.
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