Roche's CD20/CD3 Bispecific Antibody Glofitamab Receives Conditional Approval in China for Relapsed or Refractory DLBCL

Nov 08, 2023 09:58 CST Updated 09:58

Roche

Oncology Drug Research, Development, and Manufacturing

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Today (November 8th)），The official website of China's National Medical Products Administration (NMPA) has recently announced,Approved conditionally through the priority review and approval processRocheDeclaration of GefitumabMonoclonal Antibody Injection (Trade Name:Columvi (Gao Luohua) Launches in China,For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior lines of systemic therapy。Public information shows that this is RocheCD20 × CD3 Bispecific Antibody (Former Name)Glofitamab,glofitamab ，RO7082859）。

Screenshot source:NMPA Official Website

Large B-cell lymphoma is a type of non-Hodgkin lymphoma.Is an aggressive and difficult-to-treat blood cancer.Diffuse Large B-Cell Lymphoma (DLBCL)is a common type of non-Hodgkin lymphoma, while adult patients with primary mediastinal large B-cell lymphoma (PMBCL）Is a special type ofDLBCL. ForDLBCL patients,Although first-line treatment is often effective, many patients relapse or develop refractory disease, at which point treatment options are limited, survival periods are short, and there is an unmet medical need.

According toRoche disclosed information,GefitumabA bispecific T-cell engager targeting CD20 and CD3It has a unique 2:1 structure, containing two protein domains that can bind to CD20 and one protein domain that can bind to CD3.This dual-targeting strategy brings T cells close to B cells and activates T cells to release cancer-killing proteins.At the same time, it can achieve better results when used in combination with the already approved anti-CD20 monoclonal antibody.June 2023Month，The U.S. FDA announced accelerated approvalGefitumabUsed forRelapsed or refractory DLBCL or large B-cell lymphoma (LBCL) arising from follicular lymphomaTreatment of adult patients who have received second-line or multi-line systemic therapy.

Previously,Gefitumab has alreadyIn the 1/2 phase NP30179ResearchAchieved positive results in ChinaThe study was conducted in 132 patients with DLBCL who had relapsed or were refractory after prior treatment, including about one-third of patients who had previously received CAR-T cell therapy.The results showed,AcceptGefitumabPatients on fixed-duration treatment achieved durable remissions, with 56% (74/132) achieving overall response (OR) and 43% achieving complete response (CR). More than two-thirds of responders maintained their response for at least 9 months.The overall response rate is the sum of the complete response rate (all signs and symptoms of cancer disappear) and the partial response rate (the amount of cancer in the body decreases).The median duration of response was 1.5 years (18.4 months).The data from the NP30179 study have been published in The New England Journal of Medicine.

According to Dr. Krish Patel, the investigator of the NP30179 trial, as stated earlier in a press release, clinical trials have demonstrated，GefitumabProvides an opportunity for patients with relapsed or refractory diffuse large B-cell lymphoma to achieve complete remission through a fixed-duration immunotherapy, and this remission can potentially persist after the treatment ends.

References:

[1] NMPA Conditionally Approves Gefitumab Injection for Marketing. Retrieved Nov 8, 2023, from https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20231108092338150.html

[2]FDA Approves Genentech’s Columvi, the First and Only Bispecific Antibody With a Fixed-Duration Treatment for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma . Retrieved Jun 15，2023，from https://www.gene.com/media/press-releases/14994/2023-06-15/fda-approves-genentechs-columvi-the-firs

[3]FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas. Retrieved Jun 15，2023，from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell

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