NMPA (China) grants supplemental approval for Cejemly to treat unresectable stage III non-small cell lung cancer . C Stone Pharma + Pfizer
CStone Pharmaceuticals and Pfizer Inc. have announced that the National Medical Products Administration (NMPA) of China has approved sugemalimab (Cejemly) for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy. 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.
Professor Yi-Long Wu of Guangdong Provincial People’s Hospital, the Leading Principal Investigator on the GEMSTONE-301 study, said, “Patients with stage III NSCLC urgently need new treatment options, and the NMPA approval of sugemalimab brings them hope. The results from GEMSTONE-301 demonstrated that sugemalimab as a consolidation therapy had robust efficacy and a well-tolerated safety profile. It is now recommended by the Chinese Society of Clinical Oncology (CSCO) guidelines for this patient population. With proven clinical benefits, sugemalimab will potentially reshape the treatment landscape as a preferred immuno-oncology therapy for patients with mid- and late-stage lung cancer.”.
The NMPA approval is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind phase III 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 (PFS). The risk of disease progression or death was reduced by 36%, together with encouraging overall survival (OS). 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. The results of the GEMSTONE-301 study were published in The Lancet Oncology in January 2022.(previously cited).
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