China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its programmed cell death-1 (PD-1) monoclonal antibody (mAb) zimberelimab. The drug is indicated for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 expression (CPS ≥ 1) who have failed platinum-containing chemotherapy in the past. This makes zimberelimab the first and currently only PD-1 inhibitor for this specific indication.
Phase II Pivotal Regulatory Study Supports Approval
The approval is supported by data from a Phase II pivotal regulatory study conducted on April 29, 2022. The study included 90 patients in the full analysis set, where zimberelimab demonstrated an objective response rate (ORR) of 27.8%. This included a complete response (CR) in 5 patients (5.6%) and a partial response (PR) in 20 patients (22.2%). The median progression-free survival (mPFS) was 3.7 months, the median overall survival (mOS) was 16.8 months, and the median sustained response time (DoR) had not yet been reached, indicating the potential durability of the treatment’s effects.
Development Partnership and Previous Approvals
Zimberelimab was developed by Harbin Gloria in partnership with Wuxi Biologics and is the first drug of its kind to be screened by the transgenic rat platform. The drug had previously obtained market approval for use in relapsed or refractory classical Hodgkin lymphoma (cHL) in China in August 2021. Arcus Biosciences entered into a licensing deal worth USD 816 million with the partners in 2017, securing exclusive development and commercialization rights to zimberelimab in North America, Europe, and Japan.-Fineline Info & Tech
