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 PFS assessed by BICR and OS. Secondary endpoints include investigator-assessed PFS, BICR- and investigator-assessed objective response rate (ORR) and duration of response (DoR), etc.
Dr.
The data presented at ESMO GI 2023 is based on the final analysis of PFS and the interim analysis of OS with a cutoff date of
Key findings include: The BICR-assessed median PFS in the sugemalimab treatment group is 6.2 months compared with 5.4 months in the placebo group, with a hazard ratio (HR) of 0.67 (95% CI, 0.54-0.82), and a p-value of 0.0002.
The median OS in the sugemalimab treatment group is 15.3 months compared with 11.5 months in the placebo group, with an HR of 0.70 (95% CI, 0.55-0.90), and a p-value of 0.0076.
Subgroup analysis demonstrates consistent clinical benefits were observed across almost all predefined subgroups, including PD-L1 expression status.
The BICR- assessed ORR is 60.1% vs 45.2%, with a difference of 14.9% (95% CI, 5.9%-23.8%), and a p-value of 0.0011. The DoR is 6.0 months vs 4.5 months.
Sugemalimab in combination with chemotherapy shows good tolerability and safety, with no new safety signal observed.
About esophageal cancer
Esophageal cancer is one of the most common cancers globally. According to the GLOBOCAN 2020 data, there were more than 600,000 new cases of esophageal cancer in the world in 2020 (ESCC accounts for about 85%), and 544,000 deaths, with the incidence and mortality ranking 8th and 6th, respectively, among cancers globally. The incidence of esophageal cancer in
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.
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
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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