NMPA (China) approves Cejemly (sugemalimab) with chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
The National Medical Products Administration of China has approved sugemalimab (Cejemly) paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC)
The regulatory decision was supported by data from the phase III GEMSTONE-304 study (NCT04187352), in which the combination significantly improved progression-free survival (PFS) and overall survival (OS) by blinded independent central review (BICR) assessment vs chemotherapy alone in this population, meeting the prespecified primary end points of the trial.
The median BICR-assessed PFS achieved with sugemalimab plus chemotherapy was 6.2 months vs 5.4 months with chemotherapy alone, translating to a 33% reduction in the risk of disease progression or death (HR, 0.67; 95% CI, 0.54-0.82; P = .0002). The median OS with the sugemalimab combination was 15.3 months vs 11.5 months with chemotherapy alone, which translates to a 30% reduction in the risk of death (HR, 0.70; 95% CI, 0.55-0.90; P = .0076).
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