Roche's CD20/CD3 Bispecific Antibody RO7030816 (Mosunetuzumab) Granted IND Approval in China for Relapsed/Refractory Follicular Lymphoma

By | Pharma Insight

According to the latest announcement from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, Roche's Class 1 innovative drug RO7030816 has received implied approval for clinical trials, intended for: relapsed/refractory follicular lymphoma. Public information indicates that this is a bispecific antibody named mosunetuzumab, which simultaneously targets CD20 and CD3 and functions as a T-cell engager.

Screenshot source: CDE official website

Follicular lymphoma (FL) is a common indolent B-cell lymphoma and a subtype of indolent non-Hodgkin lymphoma (NHL). It arises from the malignant proliferation of germinal center B cells. The malignancy in patients typically exhibits slow growth but can become more aggressive over time. Although current treatment modalities have improved the overall survival of patients with FL, it remains classified as an incurable malignancy.

Publicly available information indicates that mosunetuzumab simultaneously targets the CD20 antigen expressed on the surface of B cells and binds to the CD3 receptor on the surface of T cells. This dual binding recruits the patient's T cells to the vicinity of B cells and activates them to eliminate the B cells.

Previously, Roche presented data from the GO40515 study on mosunetuzumab plus CHOP (M-CHOP regimen) in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL) and newly diagnosed DLBCL at the 2020 American Society of Hematology (ASH) Annual Meeting. The results showed that among R/R NHL patients treated with M-CHOP (n=7), the overall response rate (ORR) was 86%, with 71% of patients achieving a complete response (CR). The study concluded that preliminary data indicate the combination of mosunetuzumab and CHOP yields a high response rate and a manageable safety profile in patients with R/R NHL.

According to ClinicalTrials.gov, Roche has currently registered and initiated multiple clinical trials for mosunetuzumab, with indications covering non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), follicular lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma, among others.

References:

[1] Center for Drug Evaluation, National Medical Products Administration. Retrieved Sep 26, 2021, from https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731

[2] Ross Salvaris, et al (2021). Bispecific Antibodies: A Review of Development, Clinical Efficacy and Toxicity in B-Cell Lymphomas . J Pers Med. From https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147062/

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