(SUZHOU, China, August 30th, 2021) CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on researching, developing and commercializing innovative immuno-oncology therapies and precision medicines, today announced that the clinical data of GEMSTONE-301, a registrational clinical study of sugemalimab in the treatment of patients with stage III non-small cell lung cancer (NSCLC), will be presented at the European Society for Medical Oncology (ESMO) Congress 2021.
GEMSTONE-301 study is a multicenter, randomized, double-blind Phase III clinical trial designed to evaluate the efficacy and safety of sugemalimab as a consolidation therapy in patients with locally advanced/unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. In May 2021, GEMSTONE-301 study met its primary endpoint at the planned interim analysis reviewed by the independent Data Monitoring Committee (iDMC). The findings showed that sugemalimab as a consolidation therapy brought statistically significant and clinically meaningful improvement in the Blinded Independent Central Review (BICR) assessed progression-free survival(PFS). Investigator assessed PFS showed consistent results as those of the primary endpoint. Sugemalimab was well-tolerated with no new safety signals. Subgroup analyses showed that sugemalimab was associated with clinical benefits regardless of whether patients had received concurrent or sequential chemoradiotherapy prior to sugemalimab.
Currently, there has not been an approved PD-1 or PD-L1 monoclonal antibody for treating patients in stage III NSCLC who have not developed disease progression after sequential chemoradiotherapy. The GEMSTONE-301 is the first-in-class clinical study design that enrolled patients with either concurrent or sequential chemoradiotherapy to better reflect real-world clinical practice and cover a broader population. In addition, with an innovative design, GEMSTONE-302 study enrolled both stage IV squamous and non-squamous NSCLC patients. Based on the successful results from these studies, sugemalimab has the potential to become the world’s first immunotherapy approved for the treatment of all-comer patients from both stage III and stage IV NSCLC, providing a more convenient clinical treatment option for these patients.
CStone has submitted the new drug application (NDA) for sugemalimab to the National Medical Products Administration (NMPA) of China, for the treatment of patients with locally advanced/unresectable (stage III) NSCLC. The NDA for sugemalimab in patients with metastatic (stage IV) NSCLC was accepted by the NMPA last year, and is currently under review. CStone will continue to work closely with EQRx on regulatory discussions for the NDAs on the two indications of stage III and stage IV NSCLC in multiple countries or regions.
About Sugemalimab (anti-PD-L1 antibody)
Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat® transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduces the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.
Currently, sugemalimab is being investigated in a number of ongoing clinical trials, including one Phase II registration study for lymphoma (CS1001-201) and four Phase III registrational studies in stage III NSCLC, stage IV NSCLC, gastric cancer, and esophageal cancer, respectively.
CS1001-201 is a single-arm, multicenter, Phase II pivotal study designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). Based on the encouraging preliminary efficacy results, sugemalimab was granted Orphan Drug Designation for the treatment of T-cell lymphoma and Breakthrough Therapy Designation for the treatment of R/R ENKTL by the U.S. Food and Drug Administration. It has also been granted Breakthrough Therapy Designation by the National Medical Products Administration of China. The proposed indication is R/R ENKTL.
CStone formed a strategic collaboration agreement with Pfizer that includes the development and commercialization of sugemalimab in mainland China, and a framework to bring additional oncology assets to the Greater China market. CStone subsequently formed a strategic collaboration agreement with EQRx, under which EQRx licensed the exclusive rights to two key late-stage immuno-oncology assets, sugemalimab and CS1003 (anti-PD-1 antibody), for development and commercialization outside of Greater China.
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on researching, developing, and commercializing 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 world-class 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 three drug approvals in Greater China, including two in Mainland China and one in Taiwan. CStone's vision is to become globally recognized as a world-renowned biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
For more information about CStone, please visit: www.cstonepharma.com.
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