The congress, organized by the
Session: Esophageal and Gastric Cancers
Date and Time:
Presentation Type: Oral Presentation
Title: GEMSTONE-304: a phase 3 study of sugemalimab plus chemotherapy versus chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC)
Abstract number: O-4
Presenter: Professor
Principal Investigators:
The GEMSTONE-304 study is a randomized, double-blind, multi-center, placebo-controlled phase 3 registrational clinical trial, designed to evaluate the efficacy and safety of sugemalimab in combination with 5-fluorouracil plus cisplatin as the first-line treatment in patients with unresectable locally advanced, recurrent, or metastatic ESCC. The dual primary endpoints are Blinded Independent Central Review (BICR)-assessed progression-free survival (PFS) and overall survival (OS). Secondary endpoints include investigator-assessed PFS, BICR and investigator-assessed objective response rate (ORR) and duration of response (DoR), etc.
In
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 reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.
Sugemalimab is approved by 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 gastric/gastroesophageal junction 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
The marketing authorization applications (MAAs) with 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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