CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the GEMSTONE-302 registrational clinical study of sugemalimab for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) met the overall survival (OS) endpoint. The results demonstrated that sugemalimab in combination with chemotherapy showed statistically significant and clinically meaningful OS improvement in patients. Based on the previously reported impressive progression-free survival (PFS) data, the National Medical Products Administration (NMPA) of China approved sugemalimab in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC in December 2021. A detailed presentation of the OS analysis will be reported at an upcoming international academic conference.
Professor Caicun Zhou, Principal Investigator of the GEMSTONE-302 registrational clinical study of sugemalimab and Director of the Department of Oncology, Shanghai Pulmonary Hospital, Tongji University, said, "Globally, the mortality of lung cancer ranks first among all malignant tumors. The goal of first-line treatment for advanced lung cancer is to maximally prolong survival benefits for patients and to delay disease progression. The prespecified OS analysis data further confirmed that sugemalimab in combination with chemotherapy provided durable survival benefits to patients. Sugemalimab has the potential to reshape the first-line treatment landscape of advanced NSCLC and could become the preferred immune-oncology therapy for the treatment of advanced NSCLC."
Dr. Jason Yang, Chief Medical Officer of CStone, said, "We've had exciting news about sugemalimab successively in recent days. After being approved in China last month and with the first batch of prescriptions issued recently, now the OS analysis of the GEMSTONE-302 study demonstrated that sugemalimab in combination with chemotherapy brought significant improvement to the overall survival of patients even with high percentage of patients in the chemotherapy control group received subsequent PD-1/PD-L1 inhibitors, including crossover treatment based on the protocol design, after disease progression. As OS represents the gold standard efficacy endpoint in cancer clinical trials, the achievement of the OS endpoint further demonstrates the important value of sugemalimab in the first-line treatment of NSCLC. Sugemalimab is a PD-(L)1 monoclonal antibody addressing both stage III and stage IV NSCLC in all comer settings, and the new drug application of sugemalimab in stage III NSCLC is under regulatory review and a pivotal phase II trial just met its primary endpoint of overall response rate in patients with relapsed and refranctory natural killer/T-cell lymphoma. In addition, we are advancing the registrational studies of sugemalimab in gastric cancer, esophageal squamous cell carcinoma, and lymphoma, so as to enable sugemalimab to benefit a broader population of cancer patients."
About Sugemalimab
The anti-PD-L1 monoclonal antibody sugemalimab was discovered by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may allow a reduced the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.
Currently, the NMPA of China has approved sugemalimab (Cejemly®) in combination with pemetrexed and carboplatin as first-line treatment of patients with metastatic non-squamous NSCLC, lacking EGFR and ALK genomic tumor aberrations; and in combination with paclitaxel and carboplatin as first-line treatment of patients with metastatic squamous NSCLC. In addition, sugemalimab is being ...
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