Phase III GEMSTONE-301 study of sugemalimab meets primary endpoint in non-small-cell lung cancer.- CStone Pharma

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) 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. 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.