EU conditionally approves Talvey in relapsed and refractory multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted conditional marketing authorisation (CMA) of Talvey (talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy
The CMA was supported by positive results from the Phase I/II MonumenTAL-1 study (Phase I: NCT03399799; Phase II: NCT04634552), evaluating the safety and efficacy of talquetamab in patients with RRMM.
Patients in the study (0.8 mg/kg Q2W: n=145; 0.4 mg/kg QW: n=143) had received a median of five (range, 2-17) prior lines of therapy and showed meaningful overall response rates (ORR) across both doses. With a median follow-up of 12.7 months, 71.7 percent (95 percent Confidence Interval [CI], 63.7-78.9) of response-evaluable patients treated at the 0.8 mg/kg Q2W dose achieved a response, 60.8 percent achieved a very good partial response (VGPR) or better and 38.7 percent achieved a complete response (CR) or better. With a median follow-up of 18.8 months, 74.1 percent (95 percent CI, 66.1-81.1) of response-evaluable patients treated with the 0.4 mg/kg QW dose achieved a response, 59.5 percent achieved a VGPR or better and 33.6 percent achieved a CR or better. Responses were durable with a median duration of response not reached (95 percent CI, 13-Not Estimable [NE]) in the 0.8 mg/kg Q2W dose group and 9.5 months (95 percent CI, 6.7-13.3) in the 0.4 mg/kg QW dose group. An estimated 76.3 percent and 51.5 percent of patients maintained a response for at least nine months at the 0.8 mg/kg Q2W and 0.4 mg/kg QW doses, respectively.
The MonumenTAL-1 study also included 51 patients with prior T-cell redirection therapy. Patients had received a median of five (3-15) prior lines of therapy, including prior exposure to a bispecific antibody (35.3 percent), CAR-T cell therapy (70.6 percent) or both (six percent). With a median duration of follow-up of 14.8 months, 64.7 percent of patients achieved a response, 54.9 percent achieved a VGPR or better and 35.3 percent achieved a CR or better. Median duration of response was 11.9 months (95 percent CI, 4.8-NE) and the 12-month overall survival rate was 62.9 percent. The latest data from the study were recently presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (2-6 June, Chicago) and the 2023 European Hematology Association (EHA) Congress (8-11 June, Frankfurt).
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