100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy1,2
BEERSE, BELGIUM, Dec. 08, 2024 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, today announced new frontline data featuring TECVAYLI®▼ (teclistamab) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings.1,2 The MajesTEC-5 (Abstract #493) and MajesTEC-4 (Abstract #494) studies establish the potential of teclistamab for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile.1,2 These data were highlighted as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting, taking place in San Diego, California, United States from 7-10 December.1,2
Forty-nine patients with transplant-eligible NDMM were treated with teclistamab in combination with DARZALEX® (daratumumab) subcutaneous (SC) formulation, lenalidomide and dexamethasone (Tec-DRd) or daratumumab SC, bortezomib, lenalidomide and dexamethasone (Tec-DVRd) as induction therapy in the MajesTEC-5 study.1 All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10-5) and maintained through cycle 6.1
“These data from the MajesTEC-5 study build on the growing body of evidence of teclistamab combinations that support the potential combinability of teclistamab with other effective therapies, demonstrating high rates of MRD-negative responses for evaluable patients with newly diagnosed multiple myeloma,” said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, our deep expertise and understanding of multiple myeloma has shaped the regimens we’re developing, including our bispecific antibodies in new combinations, and we’re committed to exploring the full potential of our therapies to improve outcomes for patients.”
The safety profiles were manageable and consistent with individual safety profiles.1 No treatment-emergent adverse events (TEAEs) led to study treatment discontinuation or death; cytokine release syndrome (CRS; Grade 1 or 2) occurred in 65 percent of patients.1 No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS).1 Grade 3/4 TEAEs included lymphopenia (43 percent), neutropenia (57 percent) and infections (35 percent).1
“There remains opportunity to achieve even deeper and more sustained outcomes for a broader patient population in the frontline setting,” said Marc S. Raab, M.D., Heidelberg University Hospital, Germany.* “These data reinforce the potential of teclistamab when used in earlier lines and show that teclistamab can be leveraged to optimise existing standard regimens in combination.”
Results from the safety run-in of the Phase 3 MajesTEC-4 study highlighted the potential of teclistamab to be administered as a maintenance therapy following autologous stem cell transplant (ASCT).2 MajesTEC-4 is the first study to present data on a B-cell maturation antigen (BCMA) bispecific as monotherapy or combination therapy after ASCT.2
Low rates of non-haematologic Grade 3/4 TEAEs and discontinuation of treatment due to all TEAEs (5.3 percent) were observed.2 CRS events were all Grade 1/2, mostly occurring during step-up dosing, and ICANS was not observed.2 Neutropenia and infections were the most common Grade 3/4 TEAEs.2 Grade 3/4 neutropenia at 6 months showed a decreased trend in cohorts 2 and 3 with less frequent teclistamab dosing (cohort 1: 94 percent, cohort 2: 63 percent, cohort 3: 47 percent).2 A similar trend was observed for all-grade infections (cohort 1: 94 percent; cohort 2: 78 percent; cohort 3: 77 percent).2 All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6.2
Further analysis of combination therapies will be evaluated in the Phase 3 MajesTEC-7 study which is currently enrolling.3
“Teclistamab was the first BCMA bispecific therapy approved as monotherapy for relapsed and refractory multiple myeloma and plays an important role in our approach to transform outcomes for all people living with this complex disease,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Hematology, Johnson & Johnson Innovative Medicine. “The deep MRD negativity results achieved by teclistamab in earlier lines and in combination with established regimens, including daratumumab, reinforce the potential of this transformative therapy as we build on our aim towards no longer treating to progression but treating to cure.”
About MajesTEC-5 Study
MajesTEC-5 (NCT05695508) is an ongoing, Phase 2 study of teclistamab and talquetamab, evaluating the safety and efficacy of combination regimens in participants with transplant-eligible NDMM.4
About MajesTEC-4 Study
MajesTEC-4 (NCT05243797) is an ongoing, multicentre, randomised, open-label, Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with NDMM as maintenance therapy following ASCT.5
About MajesTEC-7 Study
MajesTEC-7 (NCT05552222) is a Phase 3 randomised study comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab SC and lenalidomide (Tal-DR) versus daratumumab SC, lenalidomide, and dexamethasone (DRd) in participants with NDMM who are either ineligible or not intended for ASCT as initial therapy.3
About Teclistamab
Teclistamab is an off-the-shelf (or ready to use) bispecific antibody.6 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight the cancer. Teclistamab is currently being evaluated in several combination studies.6,7,8,9,10
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with relapsed and refractory multiple myeloma 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.11 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.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. In line with European Medicine Agency (EMA) regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.
About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma (MM) 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 MM, having been used in the treatment of more than 585,000 patients worldwide.13 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with MM.14 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 MM cells, regardless of the stage of disease.16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.8 Daratumumab may also have an effect on normal cells.17 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.17,18,19,20,21,22,23,24,25,26
For further information on daratumumab, please see the Summary of Product Characteristics at: https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf.
About Multiple Myeloma
MM is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.27,28 In MM, these malignant plasma cells change and grow out of control. In the European Union, it is estimated that more than 35,000 people were diagnosed with MM in 2022, and more than 22,700 patients died.29 While some patients with MM initially have no symptoms, others can have common symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.30
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 www.innovativemedicine.jnj.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea. Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies.
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 SC. 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 Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC and/or 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; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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. None of Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*Marc S. Raab, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
1 Raab M S et al. 493 Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial. Oral presentation. American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024.
2 Zamagni E et al. 494 Phase 3 Study of Teclistamab (Tec) in Combination with Lenalidomide (Len) and Tec Alone Versus Len Alone in Newly Diagnosed Multiple Myeloma (NDMM) As Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT): Safety Run-in (SRI) Results from the MajesTEC-4/EMN30 Trial. Oral presentation. American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024.
3 A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7). Available at: https://classic.clinicaltrials.gov/ct2/show/NCT05552222. Last accessed December 2024.
4 GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX). Available at: https://clinicaltrials.gov/study/NCT05695508. Last accessed December 2024.
5 Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4). Available at: https://clinicaltrials.gov/study/NCT05243797. Last accessed December 2024.
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: December 2024.
7 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: December 2024.
8 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: December 2024.
9 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: December 2024.
10 ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (TecDara) 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/ct2/show/NCT05083169. Last accessed: December 2024.
11 Janssen.com. Janssen Marks First Approval Worldwide. Available at: https://www.janssen.com/emea/sites/www_janssen_com_emea/files/teclistamab_ec_approval_release.pdf. Last accessed: December 2024.
12 Janssen.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: December 2024.
13 Data on file. RF-439245. October 2024.
14 Sonneveld P et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2024; 390:301-313.
15 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: 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: December 2024.
16 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf. Last accessed: December 2024.
17 Moreau P et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet 2019;394(10192):29-38.
18 Facon T et al. MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med 2019;380(22):2104-2115.
19 Mateos MV et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. The Lancet 2020;395:P132-141.
20 Dimopoulos MA et al. APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol 2021;22(6):801-812.
21 Palladini G et al. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood 2020;2;136(1):71-80.
22 Chari A et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood 2017;130(8):974-981.
23 Bahlis NJ et al. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia 2020;34(7):1875-1884.
24 Mateos MV et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk 2020;20(8):509-518.
25 Sonneveld P et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2024;390(4):301-313. DOI: 10.1056/NEJMoa23120
26 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.
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28 Abdi J et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget 2013;4(12):2186–2207.
29 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: December 2024.
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CP-492505
December 2025