FDA granted accelerated approval to Talvey (talquetamab-tgvs) for 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 monoclonal antibody.
Talvey is sponsored by Janssen Biotech Inc. The full prescribing information can be found on the FDA’s website.
Efficacy was evaluated in MMY1001 (MonumenTAL-1), a single-arm, open-label, multicenter study that included 187 patients who had previously received at least four prior systemic therapies. Patients received Talvey 0.4 mg/kg subcutaneously weekly, following two step-up doses in the first week of therapy, or Talvey 0.8 mg/kg subcutaneously every 2 weeks, following three step-up doses, until disease progression or unacceptable toxicity.
The main efficacy outcome measures were overall response rate and duration of response as assessed by an Independent Review Committee using IMWG criteria. The primary efficacy population consisted of patients who had previously received at least four prior lines of therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ORR in the 100 patients receiving 0.4 mg/kg weekly was 73% and median DOR was 9.5 months. ORR in the 87 patients receiving 0.8 mg/kg biweekly was 73.6% and median DOR was not estimable. An estimated 85% of responders maintained response for at least 9 months.
The prescribing information for Talvey has a Boxed Warning for life threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity. Because of the risks of CRS and neurologic toxicity, including ICANS, Talvey is available only through a restricted program under a Risk Evaluation and Mitigation Strategy.
The most common adverse reactions reported in the 339 patients in the safety population were CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.