Janssen Subsidiary of Johnson & Johnson Launches Phase 3 Clinical Trial in China for Talquetamab in Relapsed/Refractory Multiple Myeloma

Intelligent Finance APP learned that the China Drug Clinical Trial Registration and Information Disclosure Platform showed that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ.US), has launched a Phase 3 international multicenter (including China) clinical study to evaluate the efficacy and safety of talquetamab (subcutaneous injection) in combination with other drugs in patients with relapsed or refractory multiple myeloma. Public information shows that talquetamab isAPotential "first-in-class"Humanized GPRC5D × CD3 Bispecific Antibody, submitted an application for market approval to the U.S. FDA in December 2022.

Talquetamab is an investigational, subcutaneously injectable, potential "first-in-class" bispecific antibody that simultaneously targets GPRC5D and CD3 molecules.Among them, GPRC5D (G protein-coupled receptor C5 family subtype D) is a target expressed on multiple myeloma cells, and its expression does not decrease over time. CD3 is a T-cell receptor associated with T-cell activation. Preclinical studies in mice have shown that talquetamab can recruit and activate CD3-bearing T cells, inducing T-cell-mediated cytotoxicity against multiple myeloma cells expressing GPRC5D, thereby inhibiting tumor formation and growth. Previously, the drug received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), as well as Orphan Drug and Breakthrough Therapy Designation (BTD) from the FDA. In December 2022, Janssen Pharmaceuticals announced the completion of submission of the Biologics License Application (BLA) to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma.

According to the China Drug Clinical Trial Registration and Information Disclosure Platform, Janssen has initiated a randomized, open-label, international multicenter Phase 3 clinical trial. The purpose of the trial is to compare the efficacy and safety of talquetamab subcutaneous administration in combination with daratumumab subcutaneous administration and pomalidomide (Group A), talquetamab subcutaneous administration in combination with daratumumab subcutaneous administration (Group C), and daratumumab subcutaneous administration in combination with pomalidomide and dexamethasone (Group B) in patients with relapsed or refractory multiple myeloma. The trial is planned to be conducted across 199 research centers globally, with an international enrollment of 810 participants and an enrollment of 105 participants in China.

The efficacy of Talquetamab in treating patients with multiple myeloma has been preliminarily validated in clinical trials. According to Phase 2 clinical data presented by researchers at the American Society of Hematology (ASH) Annual Meeting in December 2022:Patients with relapsed or refractory multiple myeloma who had received a median of 5 prior lines of therapy achieved response rates of 74.1% and 73.1% after receiving weekly subcutaneous injections of talquetamab at doses of 0.4 mg/kg and 0.8 mg/kg, respectively.Objective Response Rate (ORR), with a median Duration of Response (DOR) of 9 months or longer. According to a recent report released by Evaluate, further results of talquetamab for the treatment of relapsed or refractory multiple myeloma are expected to be announced in the second half of this year.