TECVAYLI® Monotherapy Shows Superior Survival vs. Standard Care in Early Relapsed, Heavily Pretreated Multiple Myeloma
Johnson & Johnson, a worldwide leader in multiple myeloma therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI® (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide. Data confirm superior progression-free survival (PFS) and overall survival (OS) with TECVAYLI® compared to standard of care as early as second line.1
Multiple myeloma is a blood cancer characterized by high rates of relapse. Despite recent advances in treatment, a significant unmet need remains for additional, well‑tolerated therapies—particularly in earlier lines of therapy for patients refractory to anti‑CD38 monoclonal antibodies and lenalidomide, commonly used medications in multiple myeloma.
The MajesTEC-9 study evaluated TECVAYLI® monotherapy in patients predominantly refractory to anti-CD38 and lenalidomide therapies.1 These results build on the unprecedented MajesTEC-3 findings published in The New England Journal of Medicine, which showed significant PFS and OS benefits with TECVAYLI® plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients who were naïve or sensitive to an anti-CD38 therapy.2 These two distinct Phase 3 studies address the continuum of unmet need.1,2,3
“The MajesTEC-9 results reinforce the potential of TECVAYLI to transform treatment earlier in the multiple myeloma journey, with an immunotherapy regimen widely available for all appropriate patients, including those commonly treated in the community setting,” said Roberto Mina, M.D., Associate Professor, Winship Cancer Institute of Emory University, formerly Assistant Professor, University of Turin, Turin, Italy.* “The impressive results show a significant improvement in progression-free and overall survival as a monotherapy in patients with refractory multiple myeloma, and together with the MajesTEC-3 results, help establish TECVAYLI as an essential therapy for patients as early as first relapse.”
The MajesTEC-9 study evaluates the efficacy and safety of TECVAYLI®, 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 relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy.1 All patients in MajesTEC-9 had to have received a prior anti-CD38 monoclonal antibody and lenalidomide.1 Overall, the majority of patients enrolled were refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%), and more than 90% were refractory to their last line of therapy.1
Those randomized to TECVAYLI® had a clinically meaningful and statistically significant 71% reduction in the risk of progression or death [hazard ratio (HR)=0.29 (95% confidence interval (CI): 0.23, 0.38)] and a 40% reduction in the risk of death [HR=0.60 (95% CI: 0.43, 0.83)].1 The safety profile of TECVAYLI®monotherapy was clinically manageable using established protocols and consistent with its known profile, with no new safety concerns identified.1 Topline data were confirmed following this first pre-specified interim analysis. Based on the strength of the data, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.
“TECVAYLI continues to break new ground as a first-in-class bispecific T-cell engager antibody and the MajesTEC-9 results are the latest example of Johnson & Johnson’s commitment to provide critical treatment options for patients at every stage of their disease,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine. “In addition to the other transformational therapies in our multiple myeloma portfolio, we continue to redefine the future for patients, bringing us another step closer to cure.”
The full results of the Phase 3 MajesTEC-9 study will be presented at a future major medical meeting and shared with global health authorities.
About TECVAYLI®
TECVAYLI® (teclistamab-cqyv) is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. TECVAYLI® received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.4
In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with RRMM who achieved and maintained a complete response (CR) or better for a minimum of six months. Since FDA approval, more than 20,800 patients have been treated worldwide with TECVAYLI®.
The European Commission (EC) granted TECVAYLI® conditional marketing authorization in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC approved a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response or better for a minimum of six months.
For more information, visit www.TECVAYLI.com.
About DARZALEX FASPRO® and DARZALEX®
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for 11 indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.5 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.
DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible.6 In 2025, DARZALEX FASPRO® was approved by the U.S. FDA and EMA as the first and only treatment for patients with high-risk smoldering multiple myeloma.
DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.5 DARZALEX®-based regimens have been used in the treatment of more than 618,000 patients worldwide and more than 68,000 patients in the U.S. alone.
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.
For more information, visit www.DARZALEX.com.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.5 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.6 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.
In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease.8 People living with multiple myeloma have a 5-year survival rate of 59.8 percent.9 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.
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