FDA Receives BLA for Talquetamab to Treat Relapsed/Refractory Multiple Myeloma

The FDA has received a biologic license application for talquetamab to treat relapsed/refractory multiple myeloma.

A biologics license application for talquetamab was submitted to the FDA for the treatment of patients diagnosed with relapsed/refractory multiple myeloma, according to a press release from Janssen Pharmaceutical.1

The submission for the first-in-class off-the-shelf bispecific T-cell engager antibody was based on data from the phase 1/2 MonumenTAL-1 trial (NCT03399799; NCT04634552), assessing talquetamab in patients with relapsed/refractory disease, the data for which were presented at the 2022 American Society of Hematology (ASH) Annual Meeting.2

“Despite the therapies that have been developed for the treatment of multiple myeloma, there remains persistent unmet needs for patients who relapse or become refractory,” Peter Lebowitz, MD, PhD, global therapeutic area head of Oncology at Janssen Research & Development, said in the press release.

Talquetamab targets both GPRC5D and CD3, a novel multiple myeloma target and primary component of the T-cell receptor that are highly expressed in myeloma cells and involved in T-cell activation, respectively.

The trial included 3 cohorts of patients. The first 2 cohorts comprised patients treated at the recommended phase 2 dose of 0.4 mg/kg weekly and 0.8 mg/kg every 2 weeks; the patients were T-cell redirection therapy naïve but were allowed to be treated with prior anti-BCMA antibody-drug conjugates. The final cohort—in which patients could receive either dose—were previously exposed to T-cell redirection therapy.

The goal of the research was to determine the safety and efficacy of the recommended phase 2 doses.

Data from the MonumenTAL-1 trial indicated that talquetamab at a dose of 0.4 mg/kg yielded a stringent complete response (sCR) rate of 23.8% in a population of 288 patients. Moreover, the CR rate was 9.8%, the very good partial response (VGPR) rate was 25.9%, and the PR rate was 14.7%. In the 0.8 mg/kg cohort, the sCR, CR, VGPR, and PR rates were 20.0%, 12.4%, 24.8%, and 15.9%, respectively. The overall response rate (ORR) was 74.1% and 73.1% in the 0.4mg/kg and 8 mg/kg arms, respectively.

Among patients who received prior T-cell redirection therapy, the ORR was 62.7%, including an sCR rate of 17.6%, a CR rate of 5.9%, a VGPR rate of 29.4%, and a PR rate of 9.8%. The median follow up was 11.8 months and the median duration of response was 12.7 months.

The most frequent grade 3/4 hematologic adverse effects (AEs) were cytopenias, with other high-grade AEs including anemia (31.5% and 24.8%), neutropenia (30.8% and 22.1%), lymphopenia (25.9% and 25.5%), and thrombocytopenia (20.3% and 16.6%) in the 0.4 mg/kg and 0.8 mg/kg cohorts, respectively. Investigators also reported infections in 57.3% and 50.3% of patients in each arm respectively; 16.8% and 11.7% of all infections were grade 3/4, respectively.


  1. Janssen submits biologics license application to U.S. FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. News release. Janssen Pharmaceutical. December 9, 2022. Accessed December 9, 2022. https://bit.ly/3VMsSwj
  2. Chari A, Touzeau C, Schinke C, et al. Talquetamab, a G protein-coupled receptor family C group 5 member D x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM): phase 1/2 results from MonumenTAL-1. Presented at 2022 American Society of Hematology (ASH) Meeting and Exposition; December 10-13, 2022; abstract 157.
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