Sugemalimab extends PFS in stage III NSCLC
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A randomized phase 3 study designed to evaluate sugemalimab as treatment of stage III non-small cell lung cancer met its primary endpoint, according to the agent’s manufacturer.
The GEMSTONE-301 study — conducted in China — evaluated sugemalimab (EQRx), an anti-PD-L1 antibody, as consolidation therapy for patients with locally advanced, unresectable stage III NSCLC who did not experience disease progression after either concurrent or sequential chemoradiotherapy.
PFS by blinded independent central review served as the primary endpoint. Secondary endpoints included OS, investigator-assessed PFS and safety.
Results of a planned interim analysis showed sugemalimab significantly prolonged PFS regardless of whether patients received concurrent or sequential chemoradiotherapy.
Sugemalimab also appeared well-tolerated. Researchers observed no new safety signals.
Full results of the multicenter, double-blind trial will be submitted for presentation at a medical conference.
Previously reported results from another randomized phase 3 trial showed the addition of sugemalimab to first-line standard platinum-based chemotherapy reduced the risk for progression or death by 50% among patients with stage IV NSCLC, regardless of PD-L1 expression level or histology.
“Stage III NSCLC represents a heterogeneous group of patients with a wide range of therapeutic outcomes. Around the world, both sequential and concurrent chemotherapy are commonly used treatment approaches for this stage of disease,” Vincent Miller, MD, physician-in-chief at EQRx, said in a company-issued press release. “These encouraging results from both the stage III and stage IV studies suggest sugemalimab is a promising potential treatment option in a broad range of patient populations.”
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