Roche's GPRC5D×CD3 Bispecific Antibody Forimtamig Granted Clinical Trial Approval in China for Relapsed/Refractory Multiple Myeloma

Oct 10, 2023 10:38 CST Updated 10:38

Roche

Oncology Drug Research, Development, and Manufacturing

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Recently, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Roche's submitted new drug forimtamig obtained clinical trial tacit permission, intended for development to treatMultiple Myeloma. Public information shows that forimtamig (RG6234) isA bispecific antibody that can simultaneously target GPRC5D and CD3 is currently undergoing Phase 1 clinical trials overseas for the treatment of multiple myeloma.。

Image Source:CDE Official Website

GPRC5D is a member of the G protein-coupled receptor family C group 5, member D,Specifically highly expressed in multiple myeloma cells and associated with poor prognostic factors.However, it is hardly expressed on normal tissues. Currently, immunotherapy targeting BCMA is one of the treatment options for patients with multiple myeloma. But for patients who are BCMA-negative or have low BCMA expression, as well as those who become BCMA-negative due to antigen immune escape after BCMA-targeted therapy, GPRC5D-targeted therapy is expected to bring new clinical benefits.

Public information shows,Forimtamig (RG6234) is a T-cell engaging bispecific antibody targeting the novel target GPRC5D. It carries two protein domains targeting GPRC5D and one protein domain targeting CD3.CD3 is the receptor on effector T cells and also an important marker on the T cell surface. The specific attack on tumor cells by T cells mediated through CD3 is the main mechanism of action for T cell-directed bispecific antibodies.Forimtamig can recruit T cells to the tumor periphery, thereby triggering an anti-tumor immune response.

Image source: Reference [2]

Previously, forimtamig has demonstrated favorable efficacy and manageable safety in a Phase 1 clinical trial for heavily pretreated patients with relapsed/refractory multiple myeloma. The productMonotherapyThe overall response rate (ORR) reached 71.4%, with 52.4% of patients achieving a very good partial response.. The research data were presented at the 2022 European Hematology Association (EHA) Congress.

Multiple Myeloma: A Common Malignant Tumor in the Hematologic SystemMultiple myeloma is a common malignant tumor in the hematologic system, accounting for approximately 10% of hematologic malignancies. It remains an incurable blood cancer, with most patients experiencing relapses and requiring subsequent treatment. As the disease progresses, each recurrence becomes more aggressive, and the remission periods achieved by new therapies gradually shorten. It is hoped that more innovative therapies will achieve breakthroughs in clinical research, soon offering patients new treatment options and clinical benefits.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Oct 08, 2023, from https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731

[2]Roche Pharma Day 2022. Retrieved September 19, 2022, from https://assets.cwp.roche.com/f/126832/x/d9b67dc4fe/pharma-day-2022_09112022_final.pdf

[3]Roche Group development pipeline. Retrieved April 26, 2023, From https://assets.roche.com/f/176343/x/2db5b67496/pharmaq123.pdf

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