China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its HX008, a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug, which was first approved in China in July this year for treating microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) expressing tumors, can now be used to treat non-resectable or metastatic melanoma with previous systemic treatment failure.
Approval Based on Clinical Study Results
The approval is based on a single-arm, open, pivotal Phase II clinical study, with the primary endpoint being the objective response rate (ORR) assessed by the Independent Imaging Data Committee (IRC) according to RECIST 1.1 criteria. The study enrolled a total of 119 patients. As of July 30, 2021, the ORR assessed by IRC was 20.2% (95% CI: 13.4-28.5; one case was in complete remission and 23 cases were in partial remission). The results demonstrated that pucotenlimab delivered significant benefits, reached the preset primary endpoint criteria, and exhibited good safety.
Clinical Research and Future Outlook
Early clinical research data have shown that pucotenlimab has excellent efficacy and good safety against a variety of tumor indications. The expanded approval for HX008 underscores Lepu Biotechnology’s commitment to advancing innovative cancer therapies and addressing unmet medical needs in the oncology space.-Fineline Info & Tech
