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The US Food and Drug Administration (FDA) has granted accelerated approval to Talvey (talquetamab) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
The continued approval of Talvey, a bispecific GPRC5D-directed CD3 T-cell engager, for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
The accelerated approval was based on results from the phase 1/2 MonumenTAL-1 trial (ClinicalTrials.gov Identifier: NCT03399799, NCT04634552). The trial included patients who had previously received at least 3 prior systemic therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Talquetamab was administered as a subcutaneous injection either on a weekly (0.4 mg/kg) or biweekly (0.8 mg/kg) schedule. Results were reported for 187 patients treated with talquetamab who were not exposed to prior T-cell redirection therapy and who had received at least 4 prior lines of therapy.
Among patients who received weekly talquetamab (n=100), the overall response rate (ORR) was 73%, with 26% of patients having a stringent complete response, 9% having a complete response, 22% having a very good partial response, and 16% having a partial response. The median time to first response was 1.2 months, and the median duration of response (DOR) was 9.5 months. The median follow-up from first response was 13.8 months.
Among patients who received biweekly treatment (n=87), the ORR was 65%, with 20% of patients having a stringent complete response, 13% having a complete response, 25% having a very good partial response, and 16% having a partial response. The median time to first response was 1.3 months, and the median DOR was not reached. The median follow-up from first response was 5.9 months, and 85% of responders maintained a response for at least 9 months.
The study also included 32 patients who were exposed to a prior bispecific antibody or chimeric antigen receptor (CAR) T-cell therapy and had received at least 4 prior lines of therapy. These patients received talquetamab at 0.4 mg/kg weekly. The median follow-up in this group was 10.4 months, 72% of patients achieved an ORR, and 59% of responders maintained a response for at least 9 months.
The most common adverse reactions in this trial were pyrexia, cytokine release syndrome (CRS), dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache. Grade 3 or 4 laboratory abnormalities included decreased lymphocyte count, neutrophil count, white blood cells, and hemoglobin.
The prescribing information for Talvey includes a boxed warning regarding the risk of CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. Because of these risks, Talvey is only available through the Tecvayli and Talvey Risk Evaluation and Mitigation Strategy (REMS). Patients should be hospitalized for 48 hours after administration of all doses with the Talvey step-up dosing schedule.
Talvey is supplied as a ready-to-use solution in 3 mg/1.5 mL (2 mg/mL) and 40 mg/mL single-dose vials. It is expected to be available in the coming weeks.
References
US FDA approves Talvey™ (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. Janssen. News release. August 10, 2023. https://www.prnewswire.com/news-releases/us-fda-approves-talvey-talquetamab-tgvs-a-first-in-class-bispecific-therapy-for-the-treatment-of-patients-with-heavily-pretreated-multiple-myeloma-301897786.html.
Package insert. Janssen; 2023. Accessed August 10, 2023. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.
This article originally appeared on MPR
References:
- US FDA approves Talvey™ (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. Janssen. News release. August 10, 2023. https://www.prnewswire.com/news-releases/us-fda-approves-talvey-talquetamab-tgvs-a-first-in-class-bispecific-therapy-for-the-treatment-of-patients-with-heavily-pretreated-multiple-myeloma-301897786.html.
- Package insert. Janssen; 2023. Accessed August 10, 2023. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.
