Johnson & Johnson has disclosed results from a phase 3 clinical trial evaluating Tecvayli as a single-agent treatment in patients with multiple myeloma, following the company’s recent announcement of positive findings from a separate study pairing Tecvayli with Darzalex.
In the newly reported trial, Tecvayli demonstrated a reduction in the risk of disease progression or death by 71% compared with standard-of-care regimens. The therapy also lowered the risk of death by 40%. The study population largely consisted of patients whose disease was resistant to prior anti-CD38 therapy and to Bristol Myers Squibb’s Revlimid, also known as lenalidomide.
The phase 3 study, known as MajesTEC-9, enrolled patients who had received between one and three previous lines of therapy. All participants had been treated previously with an anti-CD38 monoclonal antibody and lenalidomide. Among the enrolled population, 85% were refractory to anti-CD38 treatment, 79% were resistant to lenalidomide, and 90% were resistant to their most recent prior line of therapy.
In MajesTEC-9, Tecvayli was evaluated against standard-of-care regimens that included a combination of Pomalyst, Velcade, and dexamethasone, as well as a regimen consisting of Kyprolis and dexamethasone.
“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., a professor at the Winship Cancer Institute of Emory University.
Johnson & Johnson said the findings were confirmed following a pre-specified interim analysis. The company added that full study results will be presented at a future major medical conference and shared with global health authorities.
The MajesTEC-9 data follow earlier results from the late-stage MajesTEC-3 trial, which evaluated Tecvayli in combination with Darzalex in second-line multiple myeloma patients. In that study, the Tecvayli-Darzalex regimen reduced the risk of death by 54% compared with standard-of-care combinations of Darzalex and dexamethasone paired with either Pomalyst or Velcade.
Median overall survival was not reached in either treatment group, while the three-year overall survival rate was 83% in the experimental arm versus 65% in the control arm. The combination also reduced the risk of disease progression or death by 83%.
Johnson & Johnson is also studying additional Tecvayli combinations, including one with its bispecific antibody Talvey, which was approved in 2023. The company noted that multiple myeloma is associated with high relapse rates and that unmet needs remain, particularly for patients whose disease is refractory to anti-CD38 monoclonal antibodies and lenalidomide in earlier lines of therapy.
Tecvayli received approval from the U.S. Food and Drug Administration in 2022 for fourth-line use in multiple myeloma, becoming the first drug of its kind to reach the market. European regulators later approved the therapy for third-line use. Tecvayli carries a boxed warning due to risks including cytokine release syndrome and neurologic toxicity and is available only through a Risk Evaluation and Mitigation Strategies monitoring program.
Darzalex generated $11.7 billion in sales in 2024 and recorded $10.4 billion in sales through the first nine months of 2025. Sales of Tecvayli increased from $549 million in 2024 to $494 million through the first three quarters of 2025.
Phase 3 Data Highlights Tecvayli’s Potential as a Standalone Therapy
Johnson & Johnson’s newly reported Phase 3 results underscore the growing clinical value of Tecvayli as a monotherapy for patients with relapsed or refractory multiple myeloma. In the study, Tecvayli demonstrated statistically significant improvements in key efficacy endpoints compared with standard treatment options, reinforcing its ability to deliver meaningful benefit even without combination partners. The findings suggest that Tecvayli can effectively engage the immune system on its own through its BCMA-directed mechanism, offering durable disease control in a patient population with limited therapeutic choices. As J&J evaluates next regulatory and clinical steps, the Phase 3 data further position Tecvayli as an important advance in the evolving multiple myeloma treatment landscape.
