Janssen Launches Phase 2 Clinical Trial in China for Talquetamab, a Potential First-in-Class GPRC5D×CD3 Bispecific Antibody for Relapsed or Refractory Multiple Myeloma

By Medicine Observer

China's Drug Clinical Trial Registration and Information Disclosure Platform shows that talquetamab injection, a novel class 1 drug developed by Janssen (a Johnson & Johnson company), has initiated a Phase 2 clinical study for the treatment of relapsed or refractory multiple myeloma (MM). Public data indicates that this is a potential "first-in-class" humanized GPRC5D×CD3 bispecific antibody, which has previously shown positive results in early clinical trials for the treatment of multiple myeloma patients.

Screenshot source: Chinadrugtrials

GPRC5D (G protein-coupled receptor C5 family subtype D) is an innovative multiple myeloma target that is highly expressed in multiple myeloma cells and associated with poor prognostic factors. Janssen Pharmaceuticals noted in a press release that talquetamab is an investigational bispecific antibody targeting this site. It recruits T cells to the vicinity of tumor cells by binding to the CD3 receptor on the surface of T cells, thereby activating them to attack tumor cells.

According to the website of the Chinese Clinical Trial Registry and Information Disclosure Platform, this is a Phase 1/2, first-in-human, open-label, dose-escalation study of talquetamab in participants with relapsed or refractory multiple myeloma launched in China. The aim of the trial is to evaluate the efficacy of talquetamab administered at the recommended Phase 2 dose in patients with relapsed or refractory multiple myeloma. The principal investigator of the study is Dr. Lu Gui Qiu, Chief Physician at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, with plans to enroll 18 participants in China and 201 internationally.

Notably, at the 2020 American Society of Hematology (ASH) Annual Meeting, Janssen Pharmaceuticals presented early clinical trial results of talquetamab for the treatment of multiple myeloma patients. The results showed promising clinical activity for both subcutaneous injection and intravenous infusion formulations of talquetamab. At the recommended dose for the Phase 2 clinical trial of the subcutaneous injection formulation, talquetamab achieved an overall response rate of 69% (9/13), including a very good partial response (VGPR) rate of 39%.

At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Janssen Pharmaceuticals presented updated data from the Phase 1 first-in-human dose-escalation study (MonumenTAL-1) of talquetamab. With a median follow-up time of 6.3 months, the overall response rate (ORR) was 70% among 30 patients with relapsed or refractory multiple myeloma who responded to treatment at the recommended Phase 2 dose via subcutaneous administration, including a 60% very good partial response (VGPR).

These efficacy and safety data indicate that talquetamab is a promising therapeutic candidate for patients with multiple myeloma who have relapsed after multiple treatments or are refractory to other therapies. It is anticipated that this product will achieve more encouraging results in subsequent development, benefiting more cancer patients.

References:

[1] Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Nov 18, 2021, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

[2] Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma. Retrieved December 6, 2020, from https://www.janssen.com/janssen-presents-first-data-phase-1-study-gprc5dxcd3-bispecific-talquetamab-patients-relapsed-or

[3] Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma. Retrieved May 24, 2021, from https://www.businesswire.com/news/home/20210524005457/en

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