Suzhou, China, October 3, 2023—CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the data from a pivotal Phase 3 clinical trial (GEMSTONE-303), evaluating sugemalimab in combination with chemotherapy as a first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, has been accepted as a late-breaking abstract (LBA) at the European Society for Medical Oncology (ESMO) Congress 2023, and will be presented as an oral presentation at the Congress.
The GEMSTONE-303 study is a multi-center, randomized, placebo-controlled Phase 3 registrational clinical trial, designed to evaluate the efficacy and safety of sugemalimab plus capecitabine and oxaliplatin (CAPOX) as a first-line treatment in patients with unresectable locally advanced or metastatic G/GEJ adenocarcinoma with PD-L1 expression ≥5%. This study has met pre-specified dual primary endpoints of investigator-assessed progression-free Survival (PFS) and overall survival (OS), and key secondary endpoints, including blinded independent central review (BICR)-assessed PFS, and investigator-assessed objective response rate (ORR), and duration of response (DoR). In the GEMSTONE-303 study, sugemalimab in combination with chemotherapy as a first-line treatment of locally advanced or metastatic G/GEJ adenocarcinoma has demonstrated statistically significant and clinically meaningful improvement in PFS and OS. The safety profile was consistent with previous reports of sugemalimab studies, and no new safety signals were identified.
The National Medical Products Administration (NMPA) of China is currently reviewing the supplemental biologics license application (sBLA) for sugemalimab in combination with chemotherapy as a first-line treatment for locally advanced or metastatic G/GEJ adenocarcinoma. Sugemalimab will become the world’s first PD-L1 monoclonal antibody for G/GEJ adenocarcinoma indication, if approved.
The anti-PD-L1 monoclonal antibody sugemalimab was discovered by CStone using the 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 reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.
The NMPA of China has approved two indications for sugemalimab for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy and in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC.
The supplemental biologics license applications for sugemalimab for the treatment of patients with relapsed/refractory extranodal NK/T-cell lymphoma, as well as in combination with chemotherapy for first-line treatment of locally advanced or metastatic G/GEJ adenocarcinoma, and in combination with chemotherapy for first-line treatment of unresectable locally advanced, recurrent, or metastatic ESCC have been accepted by the NMPA of China and are currently under review.
In addition, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom have both accepted the marketing authorization applications (MAAs) for sugemalimab in combination with chemotherapy as a first-line treatment for metastatic NSCLC, and the two MAAs are currently under review.
CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 14 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received eleven NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone’s vision is to bring innovative oncology therapies to cancer patients worldwide.
For more information about CStone, please visit www.cstonepharma.com.
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