Johnson & Johnson's GPRC5D/CD3 Bispecific Antibody Talquetamab Recommended for Priority Review in China for Relapsed/Refractory Multiple Myeloma

On February 4, the CDE website showed that Johnson & Johnson's Talquetamab is proposed for inclusion in the priority review, indicated for monotherapy in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have previously received at least three types of treatment (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody).

Talquetamab is a first-in-class, off-the-shelf bispecific T-cell engager antibody that simultaneously targets GPRC5D on multiple myeloma (MM) cells and CD3 on T cells. GPRC5D, known as a G protein-coupled orphan receptor, is a novel drug target that is overexpressed on malignant plasma cells and its expression in normal tissues is limited to the skin (hair follicles and eccrine sweat glands) and testes (seminiferous tubules). Its expression levels are relatively independent of the BCMA target. Talquetamab activates CD3-positive T cells, inducing T-cell-mediated killing of GPRC5D-positive MM cells.

In August 2023, the FDA granted accelerated approval to Talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least four prior lines of therapy, including proteasome inhibitors, immunomodulatory agents, and CD38 antibodies.

The previous approval was primarily based on the results of the Phase II MonumenTAL-1 study. This trial evaluated the efficacy of subcutaneous Talquetamab in patients with R/R MM, including those who had received at least four prior lines of therapy and had not been treated with T-cell therapy (n=187). The study demonstrated a meaningful objective response rate (ORR). With a dosing frequency of 0.8 mg/kg every two weeks, 73.6% of patients (95% Confidence Interval [CI], range 63.0-82.4) achieved ORR. After a median follow-up time of nearly 6 months from the first response (range 0-9.5 months), 58% of patients achieved very good partial response (VGPR) or better, with 33% achieving complete response (CR) or better.

When the dosing frequency was 0.4 mg/kg once weekly via subcutaneous injection, 73.0% of patients (95% CI, range 63.2-81.4) achieved ORR. The median follow-up time from the first response was approximately 14 months (range 0.8 to 15.4 months), with 57% of patients achieving VGPR or better, including 35% who reached CR or better.

The median duration of response was not reached in the 0.8 mg/kg (once every two weeks, SC) dose group, and was 9.5 months in the 0.4 mg/kg (once weekly, SC) dose group. In the 0.8 mg/kg (once every two weeks, SC) dose group, it was estimated that 85% of responders maintained their response for at least 9 months.

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