Roche's Bispecific Cancer Therapy Mosunetuzumab Approved in China for Relapsed or Refractory Follicular Lymphoma

Dec 23, 2024 14:38 CST Updated 14:38

Roche

Oncology Drug Research, Development, and Manufacturing

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Today (December 23), the latest announcement on the official website of China's National Medical Products Administration (NMPA) stated,Roche (Roche) submittedThe marketing application for Mosunetuzumab Injection has been approved.According to the priority review announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, this drug is currently used forTreatment for patients who have previously received at least two systemic therapiesAdult patients with relapsed or refractory follicular lymphoma (FL)。

Public information shows,MotoregulinIt is a T-cell-engaging bispecific antibody targeting the CD20 antigen on the surface of B cells and the CD3 receptor on the surface of T cells.The drugRepresents a chemotherapy-free, off-the-shelf new immunotherapy option, andCan be treated with outpatient intravenous therapy。

Screenshot source:NMPA Official Website

Follicular lymphoma is the most common type of indolent non-Hodgkin lymphoma. Patients typically respond well to treatment, but relapses are common. Each time a patient relapses, the disease often becomes more difficult to treat, and early progression may be associated with poor long-term prognosis.

Motozumab (Lunsumio）Is aCD20/CD3 T Cell Engager Bispecific Antibody，It can guide T cells in the patient's body to migrate near the target B cells and release cytotoxic proteins to eliminate B cells.。The drug previously received Breakthrough Therapy Designation and Orphan Drug Status from the FDA.2022June of the year,MotoregulinApproved in the EU, for the treatment of adult patients with relapsed/refractory follicular lymphoma who have received at least two prior systemic therapies. In December of the same year, the product has obtainedUnited StatesFDA Approval, for the treatment of adult patients with relapsed or refractory FL.

▲Mechanism of Action of Motuzumab (Image Source: Roche Official Website)

According to Roche's previous press release, the FDA is based onMotozumab was granted accelerated approval based on its response rate in clinical studies.A key study named GO29781Phase 2Research has proven that,MotalizumabFor patients with relapsed or refractory follicular lymphomaWith a high and sustained response rate. In acceptingMotalizumabAmong the treated patients,80% of patients showed an objective response (includingComplete ResponseAnd Partial Response), the majority of patients maintained a response for at least 18 months (57%).。The median response duration of responders was nearly 2 years. Sixty percent of patients achievedComplete Response (CR)。Among 218 patients who received the recommended doseMozotuximabIn patients with hematologic malignancies treated, the most common adverse event (AE) was cytokine release syndrome (CRS), with a median duration of CRS events being 3 days.Other common AEs include fatigue, rash, fever, and headache.

Roche inThe 4-year long-term follow-up results of the GO29781 study were presented at the 2024 American Society of Hematology (ASH) Annual Meeting.Data show that patients achieved sustained remission, with nearly two-thirds (64.0%) of CR patients alive and progression-free at 45 months. The objective response rate (ORR) and CR rate in the overall population were 77.8% and 60.0%, respectively.Consistent results were observed in patients with a history of disease progression within 24 months after first-line treatment (POD24), a group typically more challenging to treat.

Roche also announced at this conferenceSubcutaneous injectionMotalizumab is used forThird-line and subsequent treatments for FL patientsPreliminary Analysis DataThe results showed that, compared with intravenous (IV) administration, the pharmacokinetics of the subcutaneous injection formulation demonstrated non-inferiority. The ORR assessed by the Independent Review Committee was 76.6%, and the CR rate was 61.7%.

GO29781 StudyResearcher Elizabeth Budde, M.D., earlier stated in a press release that, as a T-cell engaging bispecific antibody that can be initiated in an outpatient setting,MotezumabAnti-TheHigh response rate andFixed-Duration TreatmentMay change the treatment landscape for advanced follicular lymphoma, which previously had limited treatment options.

References:

[1] Drug Approval Certificate Delivery Information on December 23, 2024. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241223142138172.html

[2]FDA Approves Genentech’s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma. Retrieved Dec 22 , 2022. From https://www.gene.com/media/press-releases/14978/2022-12-22/fda-approves-genentechs-lunsumio-a-first

[3] European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma. Retrieved June 8, 2022, from https://www.roche.com/investors/updates/inv-update-2022-06-08

[4]New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphomaular Lymphoma. Retrieved Dec 10 , 2024. From https://www.roche.com/media/releases/med-cor-2024-12-10

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