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CStone Pharmaceuticals, a leading biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs, today announced that sugarizumab as a consolidation treatment has no disease progression after simultaneous or sequential radiotherapy and chemotherapy.
The registered clinical trial (GEMSTONE-301 study) for locally advanced/unresectable (Phase III) non-small cell lung cancer (NSCLC) patients was evaluated by the Independent Data Monitoring Committee (iDMC) in the planned interim analysis and reached the preset The main endpoint of the study
.
The results of the trial showed that suglimumab significantly improved the progression-free survival (PFS) assessed by the blinded independent central review (BICR), and the difference was statistically significant and clinically significant
Professor Wu Yilong, the principal investigator of the GEMSTONE-301 study and Professor Wu Yilong of Guangdong Provincial People’s Hospital, said: “The mortality rate of lung cancer ranks first among all malignant tumors in the world
.
Patients with stage III NSCLC lack effective treatments.
Dr.
Jiang Ningjun, Chairman and CEO of CStone Pharmaceuticals, said: “We are very excited to see that among all PD-1 and PD-L1 monoclonal antibodies, sugarizumab has become the world’s first to cover both phase III and PD-L1 monoclonal antibodies.
Dr.
Yang Jianxin, Chief Medical Officer of CStone Pharmaceuticals, said: “Currently, no PD-1 or PD-L1 monoclonal antibody has been approved for use in patients with
stage III NSCLC who have not progressed after sequential radiotherapy and chemotherapy.
The GEMSTONE-301 study uses the world’s first In addition to enrolling patients with concurrent chemoradiation and chemotherapy, the clinical design of the company is more in line with real-world clinical practice and covers a wider population
CStone Pharmaceuticals plans to submit a new drug application (NDA) for sugarizumab to the China National Medical Products Administration for the treatment of phase III NSCLC indications in the near future, and will work closely with EQRx, including the U.
S.
Food and Drug Administration (FDA).
), including the drug regulatory authorities of many countries and regions to communicate on phase III and phase IV NSCLC indications
.
The specific research data will be announced in an academic conference held in the near future
CStone Pharmaceuticals and Pfizer have reached a strategic cooperation, including CStone and Pfizer Investment on the development and commercialization of suggliumab in mainland China, and CStone and Pfizer Investment to introduce more oncology products into the Greater China region.
CStone Pharmaceuticals has reached a strategic cooperation with EQRx of the United States, and exclusively authorized EQRx to develop and commercialize two tumor immunotherapy drugs in the late stage of research and development outside of Greater China.
