Suzhou, China, June 13th, 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-304), evaluating sugemalimab in combination with chemotherapy as the first-line treatment for unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), will be presented in an oral session at the ESMO World Congress on Gastrointestinal Cancer 2023. The congress, organized by the European Society for Medical Oncology (ESMO), will be held in Barcelona, Spain, from June 28th to July 1st, 2023.
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 January 2023, the GEMSTONE-304 study met both primary endpoints. Sugemalimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in BICR-assessed PFS and OS compared with placebo in combination with chemotherapy. The safety profile was consistent with previous reports of sugemalimab and no new safety signal was observed. The supplemental biologics license application (sBLA) for sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced, recurrent, or metastatic ESCC has been accepted by the National Medical Products Administration (NMPA) in China and is currently under review. Sugemalimab potentially could become the first anti-PD-L1 monoclonal antibody worldwide approved for the first-line treatment of unresectable locally advanced, recurrent or metastatic ESCC.
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 China 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 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 China and are currently under review.
The marketing authorization applications (MAAs) with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for sugemalimab as a first-line treatment for metastatic NSCLC are under review.
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 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 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received ten 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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