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 registrational clinical study (GEMSTONE-201) of sugemalimab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) met the primary endpoint. Results showed that sugemalimab significantly enhanced the objective response rate (ORR), as assessed by the Independent Radiology Review Committee (IRRC), compared with historical control. The investigator-assessed ORR was consistent with the evaluation by IRRC. Sugemalimab also demonstrated a well-tolerated safety profile in patients with R/R ENKTL, and no new safety signals were observed. CStone plans to submit a new drug application (NDA) in the near term to the National Medical Products Administration (NMPA) of China for sugemalimab as the treatment of R/R ENKTL and will present the topline results at an upcoming international academic conference.
Professor Huiqiang Huang of Sun Yat-sen University Cancer Center, the Principal Investigator of the GEMSTONE-201 study, said, "R/R ENKTL is highly malignant and aggressive. For a long time, there was no effective therapeutic drug in clinic, leading to a low cure rate and poor prognosis. The success of the GEMSTONE-201 study demonstrated that sugemalimab may become a new treatment option for patients with R/R ENKTL to fulfill the extremely urgent medical needs of this patient population."
Dr. Jason Yang, Chief Medical Officer of CStone, said, "We are very glad that the registrational study of sugemalimab in treatment of R/R ENKTL met the primary endpoint. This is the third success in pivotal clinical studies of sugemalimab after the prior two Phase 3 trials in stage III and stage IV non-small cell lung cancer (NSCLC) also met the primary endpoint. Until now, no anti-PD-(L)1 monoclonal antibody has been approved for R/R ENKTL, so we very much look forward to seeing that more patients would benefit from sugemalimab."
The NMPA of China has approved the NDA of sugemalimab in combination with chemotherapy for treatment-naïve metastatic (stage IV) NSCLC patients. In addition, another NDA of sugemalimab in stage III NSCLC is under regulatory review. Sugemalimab is expected to provide a new treatment option for both stage III and stage IV NSCLC patents in the future. Sugemalimab has also demonstrated the tremendous potential with its unique mechanism of action and attractive clinical data in the treatment of lung cancer, lymphoma and other tumors.
About ENKTL
Extranodal natural killer/T-cell lymphoma (ENKTL) is a subtype of mature T cell and NK cell lymphoma. In 2012, a multicenter pathological classification survey of 10,002 lymphoma patients from China showed that ENKTL accounted for approximately 6% of all lymphomas and 28% of mature T-cell and NK-cell lymphomas. There is no existing effective salvage treatment for patients with R/R ENKTL whose disease has progressed on a L-asparaginase-based standard regimen. Patients also typically respond poorly to conventional treatments. Clinicians often have limited treatment options for such patients due to rapid disease progression and poor survival outcomes with a one-year survival rate of less than 20%. In China, the currently available targeted monotherapy for these patients has a complete response (CR) rate of approximately 6%. Thus, there are significant unmet medical needs in patient who did not respond to first-line treatment.
About sugemalimab
The potential best-in-class anti-PD-L1 monoclonal 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 ...
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