▎Edited by the WuXi AppTec content teamOn February 28, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that cevostamab, a Class 1 new drug submitted by Roche, has been approved for clinical trials and is proposed for development to treatMultiple Myeloma. According to publicly available information from Roche, cevostamab (RG6160) is a research-stage product of the company.Bispecific antibody targeting Fc receptor-like protein 5 (FcRH5) expressed on myeloma cells and CD3 on T cells.
Screenshot source: CDE official website
Multiple Myeloma (MM) is an incurable blood cancer that canShadowResonanceAWhite blood cells called plasma cells, which are present in the bone marrow.In multiple myeloma, these plasma cells change, spread rapidly, and replace normal cells in the bone marrow with tumors.Most patients may experience symptoms including fractures or pain, low red blood cell counts, fatigue, high calcium levels, and kidney problems or infections.Cevostamab is a Roche research productFcRH5 × CD3 Bispecific Antibody, Proposed for Development in the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM).FcRH5 receptor is expressed in all myeloma cells, and its expression level is higher in myeloma cells and normal plasma cells than in normal B cells.Cevostamab binds to the CD3 receptor on the surface of T cells, recruiting T cells to the vicinity of multiple myeloma cells and activating them to kill myeloma cells.▲Introduction to Cevostamab (Image Source: Reference [4])
According to the abstract of clinical trial results published by Roche at the 2021 American Society of Hematology (ASH) Annual Meeting, as of May 18, 2021, 160 patients with relapsed or refractory multiple myeloma (RRMM) who had received multiple prior treatments were treated with different doses of cevostamab. These patients had received an average of six prior therapies, including CAR-T therapy, bispecific antibodies, antibody-drug conjugates (ADCs), and B-cell maturation antigen (BCMA)-targeted therapies, among others.The trial results showed that, in patients receiving cevostamab treatment above the target dose,Subgroup of patients who had previously received CAR-T therapyTheORR was 36.7%（4/9），The ORR in the subgroup of patients who received other bispecific therapies was 33.3%.（3/9），The ORR in the patient subgroups who received ADC or anti-BCMA therapy was 50.0% (7/14) and 36.4%, respectively.(8/22). The median follow-up time for all responders (n=61) was 8.1 months, with an estimated median duration of response of 15.6 months. According to the conclusions drawn by the researchers,cevostamabMonotherapy demonstrated clinically meaningful activity in a large cohort of heavily pretreated RRMM patients, including those previously exposed to CAR-T therapy, bispecific antibody therapy, and ADC therapy.ClinicalTrialsPlatform information shows that Roche is conducting multiple Phase 1/2 clinical studies to evaluate cevostamab as a monotherapy or in combination therapy for treatment.RRMMThe efficacy and safety of patients who experienced disease progression after multiple treatments, including anti-BCMA therapy.References:
[1] Official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). Retrieved , 2024, fromhttps://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
[2] Suzanne Trudel, Adam
D Cohen, Amrita
Y. Krishnan, et al. Cevostamab Monotherapy Continues to Show
Clinically Meaningful Activity and Manageable Safety in Patients with Heavily
Pre-Treated Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from
an Ongoing Phase I Study. Retrieved November 23, 2021, from https://ashpublications.org/blood/article/138/Supplement%201/157/478075/Cevostamab-Monotherapy-Continues-to-Show?searchresult=1
[3]
A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell
Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory
Multiple Myeloma (CAMMA 2). https://classic.clinicaltrials.gov/ct2/show/NCT05535244?term=Cevostamab&draw=2&rank=4
[4] Roche Pharma Day 2022. Retrieved September 19, 2022, from https://assets.cwp.roche.com/f/126832/x/d9b67dc4fe/pharma-day-2022_09112022_final.pdf
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