Janssen Submits Talquetamab for Priority Review in China as First-in-Class GPRC5D×CD3 Bispecific Antibody for Relapsed/Refractory Multiple Myeloma

Feb 05, 2024 08:03 CST Updated 08:03

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

On February 4, the CDE website showed that Johnson & Johnson'sTaqiutumab（Talquetamab) Proposed for Priority ReviewIndication: Monotherapy for relapsed or refractory multiple myeloma (MM) in patients who have received at least three prior treatments (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody).R/R MM) Adult patients.

Talquetamab is a first-in-class, off-the-shelf bispecific T-cell engager antibody that simultaneously targets GPRC5D on 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), with its expression levels being 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 approvalTalquetamabLaunched for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least four types of therapy, including proteasome inhibitors, immunomodulatory agents, and CD38 antibodies.

The previous approval was mainly based on Phase IIMonumenTAL-1 Study ResultsResult. This trialAssessment of the skinEfficacy of Subcutaneous Injection of Talquetamab in Patients with R/R MM,This includes previous contactHaving received at least 4 treatments and not undergone T-cell therapyPatient of law (n=187), which showed a meaningful objective response rate (ORR).When the dosing frequency was 0.8 mg/kg every two weeks via subcutaneous injection, 73.6% of patients (995% Confidence Interval [CI], ranging from 63.0 to 82.4) Achieve ORR.From the first appearance of relief in subjects, the median follow-up time was nearly 6 months (Scope 0-9.5 months), 58% of patients achieved a very good partial response (VGPR).Or better, with 33% of patients achieving complete remission (CR) or better.

When the dosing frequency is 0.4 mg/kg administered subcutaneously once a week, 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% reaching CR or better.

0.8 mg/kg（Every two weeks,SC) The median duration of response was not reached in the dose group,0.4 mg/kg (weekly, SC) dose group was 9.5 months. 0.8 mg/kg (Every two weeks, SC) The estimated 85% of subjects in the dose group had a response duration of at least 9 months.

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