Presentation session: Gastrointestinal tumours, upper digestive
Time: 17:20 - 17:25,
Format: Oral Presentation
Title: LBA79- GEMSTONE-303: prespecified progression-free survival (PFS) and overall survival (OS) final analyses of a phase 3 study of sugemalimab plus chemotherapy vs placebo plus chemotherapy in treatment-naive advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
Leading PI: Professor
Presenter: Profess
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.
About Sugemalimab
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
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
In addition, the
About CStone
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
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