China - CStone Pharmaceuticals ('CStone', HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental biologics license application (sBLA) for sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
Professor Li Jin, Principal Investigator of the GEMSTONE-304 study and Director of the Department of Oncology, East Hospital, Tongji University, said, 'Esophageal cancer is one of the most common cancer types in China and also one of the malignancies with the highest mortality rates globally. About 70% of patients with esophageal cancer have progressed to locally advanced or advanced stages at the time of initial diagnosis. In addition, 50%-60% of patients with resectable esophageal cancer relapse or develop distant metastases after radical surgery. There are still unmet medical needs for this patient population. The GEMSTONE-304 study demonstrated that sugemalimab in combination with chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared to first-line chemotherapy for ESCC, with a good safety profile, providing a new treatment option for advanced ESCC patients.'
Dr. Jason Yang, CEO of CStone, said, 'CStone is committed to addressing the unmet medical needs, and we are delighted to announce that the NMPA has accepted our application for the fifth indication of sugemalimab in China. If approved, sugemalimab has the potential to become the first PD-L1 monoclonal antibody in the world for the treatment of locally advanced, recurrent, or metastatic ESCC. We will continue to work closely with the NMPA and anticipate the significant benefits that sugemalimab could bring to a large number of patients.'
This sBLA of sugemalimab was accepted based on the data from the GEMSTONE-304 study. It 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 first-line treatment in patients with unresectable locally advanced, recurrent, or metastatic ESCC. The primary endpoints are Blinded Independent Central Review (BICR)-assessed PFS and OS, and secondary endpoints include investigator-assessed PFS, BICR and investigator-assessed objective response rate (ORR) and duration of response (DoR).
In January 2023, the GEMSTONE-304 study met its primary endpoints. The results showed that 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 findings across the studies in additional diseases with sugemalimab and no new safety signal was observed. Detailed data from this study will be presented at an upcoming academic conference.
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 China accounts for more than half of the world, about 90% of which are ESCC, and most of the patients with ESCC have been diagnosed in the advanced stage and missed the opportunities of curative treatments.
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.
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.
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