Posted: Friday, August 11, 2023
On August 9, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of talquetamab-tgvs (Talvey), a first-in-class bispecific antibody for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s).
This accelerated approval is based on the phase II MonumenTAL-1 study, which included 32 patients who had received at least four prior lines of therapy and who were not exposed to prior T-cell redirection therapy (n = 187). At the subcutaneous biweekly dose of 0.8 mg/kg, the overall response rate was 73.6% (95% confidence interval [CI] = 63.0%–82.4%). With a median follow-up of nearly 6 months from first response among responders, 58% of patients achieved a very good partial response or better, including a complete response rate of 33%. At the subcutaneous weekly dose of 0.4 mg/kg, the overall response rate was 73.0% (95% CI = 63.2%–81.4%). With a median follow-up of nearly 14 months from first response among responders, 57% of patients achieved a very good partial response or better, including a complete response rate of 35%.
The median duration of response was not reached with the 0.8 mg/kg subcutaneous biweekly dose group and 9.5 months with the 0.4 mg/kg subcutaneous weekly dose. Among patients receiving the 0.8 mg/kg subcutaneous biweekly dose, an estimated 85% of responders maintained response for at least 9 months.
The safety profile for talquetamab includes a boxed warning for cytokine-release syndrome and neurologic toxicity including immune effector cell–associated neurotoxicity syndrome; warnings and precautions include oral toxicity and weight loss, infections, cytopenias, skin toxicity, hepatoxicity, and embryofetal toxicity. Talquetamab is available only through a restricted program called the Tecvayli and Talvey Risk Evaluation and Mitigation Strategy.