Pfizer : China Approves Sugemalimab To Treat Unresectable Stage III Non-small Cell Lung Cancer

(RTTNews) - Pfizer Inc. (PFE) and CStone Pharmaceuticals said Monday that the National Medical Products Administration of China has approved sugemalimab or Cejemly for the treatment of patients with unresectable stage III non-small cell lung cancer or NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy.

Pfizer noted that, together with the previous approval of the treatment for first-line stage IV NSCLC patients, sugemalimab is now the only anti- PD-1/PD-L1 monoclonal antibody for both stage III and stage IV NSCLC patients.

The approval was based on the GEMSTONE-301 study, a multicenter, randomized, double-blind phase 3 clinical trial, designed to evaluate the efficacy and safety of sugemalimab as a consolidation therapy in patients with unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy.

Sugemalimab significantly improved patients' progression-free survival or PFS. The risk of disease progression or death was reduced by 36%, together with encouraging overall survival.

Subgroup analyses demonstrated clinical benefits regardless of whether patients received prior concurrent or sequential chemoradiotherapy. Sugemalimab had a well-tolerated safety profile, and no new safety signals were observed.