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Iovance reports 24.6% ORR in mNSCLC trial, plans sBLA for lifileucel in 2027
IOVAIovance Biotherapeutics, Inc.
Iovance Biotherapeutics announced updated results from Cohorts 1 and 2 of its Phase 2 IOV-LUN-202 trial for lifileucel in previously treated non-squamous metastatic non-small-cell lung cancer. The data showed a 24.6% objective response rate (ORR) across 69 patients, consistent with prior reports. A retrospective analysis identified a biomarker-enriched subgroup defined by KRAS wild-type status, HER2 wild-type status, and smoking history that achieved a 59.1% ORR. The company plans to initiate POSILITY, a prospective biomarker-enriched study with registrational intent, in November 2026. These findings support the planned submission of a supplemental Biologics License Application (sBLA) for lifileucel in non-squamous mNSCLC in 2027. Iovance Biotherapeutics is a commercial biotechnology company developing and delivering tumor infiltrating lymphocyte cell therapies for cancer.