Johnson & Johnson Submits sBLA for TECVAYLI plus DARZALEX FASPRO in Relapsed/Refractory Multiple Myeloma Following MajesTEC-3 Phase 3 Data Showing 83.4% 36-Month PFS
Johnson & Johnson
Medical Device R&D and Manufacturer
On December 9, Johnson & Johnson announced on its official websiteItsLatest Data from Phase III Clinical Study MajesTEC-3.Studies have shown that for patients with relapsed or refractory multiple myeloma (RRMM),TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)It can be used as a second-line treatment regimen at the earliest, showing significant potential.Among patients without disease progression at six months,91%Remained progression-free at the three-year mark.
The MajesTEC-3 study is part of the MajesTEC clinical program, evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO (Tec-Dara), compared with standard treatment regimens DPd/DVd (DARZALEX FASPRO + dexamethasone plus pomalidomide or bortezomib), in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.
Follow-up data from nearly three years shows,This regimen reduces the risk of disease progression or death by 83% compared to the standard treatment regimen.(Hazard Ratio [HR] 0.17; 95% Confidence Interval [CI] 0.12-0.23; P<0.0001).Among patients who were progression-free at 16 months, 91% remained progression-free after three years.
In terms of key secondary endpoints,The SolutionSignificant improvements were observed compared to standard treatment regimens:
≥CR Rate: 81.8% vs 32.1%
ORR：89.0% vs 75.3%
MRD Negative Rate: 58.4% vs 17.1%(All P<0.0001)
Overall survival (OS) was also significantly improved, with three-year OS rates of83.3% vs 65.0%(HR=0.46; P<0.0001). In addition, Tec-Dara also outperformed standard treatment in terms of asymptomatic survival and patient quality of life (QoL).
In terms of safety, the incidence of grade 3/4 treatment-emergent adverse events (TEAEs) was comparable between Tec-Dara and the control group (95.1% vs 96.6%), mainly caused by cytopenia and infections. The infection rate significantly decreased after the implementation of immunoglobulin supplementation and preventive strategies, along with a switch to monthly dosing.
60.1% of patients experienced cytokine release syndrome, but all cases were grade 1/2, well-controlled, and did not lead to treatment interruption; the incidence of ICANS was 1.1%. The incidence of serious adverse events was 70.7% (62.4% in the control group), but the discontinuation rates were low (4.6% vs 5.5%). The incidence of grade 5 TEAEs was 7.1% and 5.9%, respectively.
Based on these results, Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA,Application for the Combination of TECVAYLI and DARZALEX FASPRO in RRMM Treatment.The combination obtainedFDA Breakthrough Therapy Designation (BTD), and through the Real-Time Oncology Review (RTOR) to expedite the evaluation process, while it has also been submitted to Brazil's ANVISA.
This research achievement was presented as the latest breakthrough oral report and press release content,Released at the 2025 American Society of Hematology (ASH) Annual Meeting, and simultaneously published in The New England Journal of Medicine.
Maria-Victoria Mateos, Hematology Consultant at Salamanca University Hospital, stated that TECVAYLI combined with DARZALEX FASPRO demonstrates significant efficacy, manageable safety, and suitability for outpatient use. By simultaneously targeting BCMA and CD38 to synergistically activate the immune system, it extends progression-free survival and overall survival in second-line treatment, potentially transforming the standard of care.
"With these data, we are entering a new era in the treatment of multiple myeloma, where the first bispecific combination has demonstrated superior overall survival as early as the second-line stage," said Dr. Sen Zhuang, Vice President of Clinical Research in Oncology at Johnson & Johnson Innovative Medicine.
Summary
The three-year follow-up data of MajesTEC-3 show that TECVAYLI combined with DARZALEX FASPRO (Tec-Dara) significantly outperforms the standard-of-care regimen (DPd/DVd) in key indicators such as progression-free survival (PFS), overall response rate (ORR), complete response rate (CR rate), and overall survival (OS). This combination is suitable for second-line RRMM patients, demonstrating significant efficacy and manageable safety, providing a new viable option for second-line treatment.
About TECVAYLI
TECVAYLI is a first-in-class innovationCD3×BCMA Bispecific Antibody, by simultaneously binding T cells and multiple myeloma cells to activate the immune system. The drug was approved inOctober 2022 (U.S. FDA)andAugust 2022 (EU)Approved for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three to four prior lines of therapy. In 2024, the United States and the European Union further approved the adjustment of dosing frequency in patients achieving at least six months of complete response (CR).1.5 mg/kg every two weeks。
About DARZALEX
DARZALEX FASPRO (subcutaneous formulation) and DARZALEX (intravenous formulation) are bothCD38-targeted antibody, whereinDARZALEX is the world's first approved CD38-targeted drug for the treatment of multiple myeloma.Since its approval by the U.S. FDA in 2015, DARZALEX has had eight indications; DARZALEX FASPRO has had 11 indications since its approval in 2020, including various regimens for newly diagnosed patients, and it is the only subcutaneous CD38 antibody. In 2025, DARZALEX FASPRO was approved by the U.S. FDA and EMA as the first treatment for...High-Risk Smoldering Multiple MyelomaTreatment Plan.
In August 2012, Janssen Biotech, Inc. entered into a global agreement with Genmab A/S, granting Janssen exclusive rights to develop, manufacture, and commercialize daratumumab.
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