Johnson & Johnson (J&J) has released positive top-line results from the phase 3 MajesTEC-9 trial, demonstrating the effectiveness of Tecvayli as a standalone treatment for multiple myeloma. This follows recent clinical milestones involving the drug’s use in combination therapies.
Key clinical findings The trial evaluated patients who had previously received one to three lines of therapy and showed resistance to standard treatments, including anti-CD38 antibodies and lenalidomide. Key data points include:
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Risk reduction: Tecvayli demonstrated a 71% reduction in the risk of disease progression or death compared to standard-of-care regimens.
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Mortality rates: The therapy was associated with a 40% lower risk of death.
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Patient profile: The study population was highly pre-treated, with 85% of participants being refractory to anti-CD38 therapies and 79% resistant to lenalidomide.
Strategic and financial impact The findings from MajesTEC-9, alongside earlier results from the MajesTEC-3 study, position Tecvayli as a potential primary option starting from a patient’s first relapse. Experts suggest this could simplify immunotherapy delivery in community healthcare settings.
Financially, Tecvayli is seeing rapid scale-up, generating $494 million in revenue during the first three quarters of 2025. While the drug’s label includes warnings for potential side effects such as cytokine release syndrome and neurological toxicity, it remains a central component of J&J’s oncology portfolio, complementing the performance of their established blockbuster, Darzalex.
Source: https://www.fiercepharma.com/pharma/after-succeeding-combo-darzalex-jjs-tecvayli-shines-solo-act