CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced that a registrational clinical trial (GEMSTONE-301 study) of the anti-PD-L1 monoclonal antibody sugemalimab in patients with stage III NSCLC met its primary endpoint at a 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 PFS in patients with locally advanced/unresectable NSCLC without disease progression after concurrent or sequential chemoradiotherapy. Investigator assessed PFS showed consistent results as those of the primary endpoint. Sugemalimab was well-tolerated with no new safety signals. Subgroup analyses demonstrated that sugemalimab was associated with clinical benefit regardless of whether patients received concurrent or sequential chemoradiotherapy prior to sugemalimab.
"Lung cancer is the leading cause of cancer-related mortality globally. There are currently few effective therapies for patients with stage III NSCLC whose disease did not progress after sequential chemoradiotherapy," said Professor Yi-long Wu of Guangdong Provincial People's Hospital, the Leading Principal Investigator on the GEMSTONE-301 study," The successful results from the study indicate that sugemalimab will meet the urgent treatment needs of these patients."
"We are excited that sugemalimab becomes the first anti-PD-1/PD-L1 monoclonal antibody in the world to cover both stage III and stage IV NSCLC patients," said Dr. Frank Jiang, Chairman and CEO of CStone, "The continued success of sugemalimab in lung cancer demonstrates CStone's leading research and development capabilities in the field of immuno-oncology. We are working closely with Pfizer and EQRx, our commercial partners for sugemalimab, on the next steps in our joint efforts to deliver this best-in-class drug to patients worldwide."
"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," said Dr. Jason Yang, Chief Medical Officer of CStone, "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. CStone is committed to providing treatment options to address the unmet medical needs. The GEMSTONE-301 study will advance the use of multidisciplinary treatment approaches in China to improve the quality of the diagnosis and treatment of stage III NSCLC. We will continue to explore the potential of sugemalimab in registrational clinical trials for patients with hematologic malignancies and advanced gastric and esophageal cancers."
CStone plans to submit an NDA to the NMPA for sugemalimab in stage III NSCLC, and will work with EQRx to hold regulatory discussions on the indications of stage III and stage IV NSCLC with regulators in multiple countries, including the U.S. Food and Drug Administration (FDA). Specific study data will be presented at an upcoming academic conference.
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 global development and commercialization outside of Greater China.
About NSCLC
In recent years, China has had rising lung cancer incidence. According to the latest estimates on the global burden of cancer released by International Agency for Research on Cancer (IARC), in 2020, an estimated 0.82 million new lung cancer cases and 0.71 million new lung cancer deaths occurred in China. Among all Chinese cancer patients, lung cancer is the leading cause of cancer-related deaths. NSCLC is the most common type of lung cancer.
There ...
(All Rights Reserved)