MajesTEC-9 is the second positive Phase 3 study to reinforce the strength of Johnson & Johnson’s TECVAYLI^® as early as second line¹

TECVAYLI^® delivered deep and durable responses, with nearly two-thirds of patients achieving a complete response or better²

Beerse, Belgium, May 29, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced new data from the Phase 3 MajesTEC-9 study demonstrating clinically meaningful and statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with TECVAYLI^®▼ (teclistamab) versus standard of care regimens in patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy.² In a patient population whose myeloma was predominantly refractory to anti-CD38 therapy and lenalidomide, teclistamab reduced the risk of disease progression or death by 71% and the risk of death by 40%.² These data (Abstract #7507) will be presented as an oral session today at the annual American Society of Clinical Oncology (ASCO) Annual Meeting, with simultaneous publication in The New England Journal of Medicine.³

Expert and company perspectives support the strength of teclistamab
“These findings further reinforce teclistamab’s potential to meaningfully improve survival outcomes for patients with multiple myeloma in earlier lines,” said Roberto Mina, M.D., Associate Professor, Winship Cancer Institute of Emory University.* “These results will continue to transform the role of bispecifics in clinical decision-making as early as second line — offering a steroid-sparing, community-based therapy for patients across all practice settings, regardless of prior anti-CD38 exposure.”

“As an established and convenient off-the-shelf bispecific antibody in advanced stages of relapsed or refractory multiple myeloma, teclistamab continues to build momentum across the treatment landscape. These latest data add further clinical evidence supporting the potential of teclistamab-based regimens to move into earlier lines of treatment and to become a potential new standard of care as early as the second line,” said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “We have submitted an application to the European Medicines Agency seeking approval for an indication extension of teclistamab, supported by MajesTEC-9 data, and look forward to working with health authorities to bring this important new option to patients in Europe.”

“Together with the unprecedented results of teclistamab plus daratumumab subcutaneous, a potential new standard of care, at ASH 2025, these data add to the growing body of evidence reinforcing the clinical power of teclistamab earlier in the treatment paradigm,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “These findings further demonstrate how we’re leading in multiple myeloma as we bring new options to better match the right therapy to the right patient at each stage of disease.”

MajesTEC-9 study results
The MajesTEC-9 study evaluated teclistamab, a bispecific T-cell engager antibody therapy, versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received 1 to 3 prior lines of therapy, including lenalidomide and a CD38 monoclonal antibody.² Efficacy benefits were observed in patients predominantly refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%), and more than 90% of patients who were refractory to their last line of therapy.² 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<0.0001) 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, demonstrating significant improvements in both PFS and OS.² 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<0.0001).²

The overall safety profile for teclistamab in the study was consistent with its known safety profile. Teclistamab had similar rates of treatment-emergent adverse events (TEAEs) compared to standard of care (99.7% vs. 97.9%).² Grade 3/4 TEAEs were reported by 84.9% of patients treated with teclistamab, compared with 76.3% of patients receiving standard of care.² There was a low incidence of Grade 5 TEAEs across the two treatment groups (6.5% vs. 3.5%).² The majority of Grade 5 TEAEs in both groups were due to infections (5.5% vs. 2.8%) and most occurred within the first six months of treatment initiation.² Infections were more frequent with teclistamab compared to standard of care (Grade 3/4, 41.6% vs. 29.0%).² However, rates of Grade 3 or higher infections declined over time.² Cytokine release syndrome occurred in 66.0% of patients treated with teclistamab, and were mostly Grade 1 and managed with standard mitigation strategies.² All events resolved and none led to treatment discontinuation.² Immune effector cell-associated neurotoxicity syndrome was infrequent, occurring in 4.1% of patients and primarily Grade 1/2. Median duration of treatment on teclistamab was almost two times longer than standard of care (13.1 vs 7.0 months).²

Regulatory review and next steps
Based on these results, Johnson & Johnson is working with regulatory bodies globally to consider teclistamab as early as second line. Applications for regulatory approval based on this data have been submitted to the U.S. Food and Drug Administration and the European Medicines Agency.

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 CD38 monoclonal antibody.¹ The primary endpoint is progression-free survival (PFS); secondary endpoints include complete response or better (≥CR), duration of response (DoR), time to next treatment (TTNT), progression-free survival on next line of therapy (PFS2), 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.⁴In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.⁵

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.⁶^,7Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. Teclistamab is currently being evaluated in several combination studies.^6,8,9,10,11

To date, more than 26,000 patients have been treated worldwide with teclistamab.¹²

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: 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.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.¹³^,14In 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.^12,13 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.¹⁵Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.¹⁶^,17,18Whilst 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.¹⁹

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. 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/ 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.

*Roberto Mina, M.D., Associate Professor, Winship Cancer Institute of Emory University, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

^END

Key Search Terms

MajesTEC-9 Phase 3 clinical trial
TECVAYLI
Teclistamab
Teclistamab monotherapy
Teclistamab plus daratumumab
Relapsed and or refractory multiple myeloma (RRMM)
Early relapse multiple myeloma
Second-line multiple myeloma treatment
First relapse therapy for multiple myeloma
Refractory multiple myeloma standard of care
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
EMEA haematology pipeline
Multiple myeloma innovation
Multiple myeloma treatment
Anti-CD38 refractory multiple myeloma

References:

1 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: https://clinicaltrials.gov/study/NCT05572515. Last accessed: May 2026.

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 Touzeau C, et al. Teclistamab monotherapy in multiple myeloma with 1–3 prior lines of therapy. N Engl J Med. 29 May 2026.

4 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: https://innovativemedicine.jnj.com/emea/janssen-marks-first-approval-worldwide-tecvaylirvteclistamab-ec-authorisation-first-class-bispecific. Last accessed: May 2026.

5 Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-reduced-dosing-frequency-for-janssens-bispecific-antibody-tecvayli-teclistamab. Last accessed: May 2026.

6 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf. Last accessed: May 2026.

7 Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505.

8 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: May 2026.

9 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04722146. Last accessed: May 2026.

10 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT04586426. Last accessed: May 2026.

11 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT04108195. Last accessed: May 2026.

12 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide.

13 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.

14 American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/if-you-have-multiple-myeloma. Last accessed: May 2026.

15 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27. Last accessed: May 2026.

16 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.

17 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.

18 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.

19 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: May 2026.

CONTACT: Media contact:
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jmildon@its.jnj.com
+44 7920 418 552

Investor contact:
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investor-relations@its.jnj.com

New TECVAYLI®▼ (teclistamab) data demonstrate superior progression-free and overall survival versus standard of care as early as first relapse in multiple myeloma