Iovance Biotherapeutics announced updated results from its Phase 2 IOV-LUN-202 trial for its TIL therapy, lifileucel, in metastatic non-small-cell lung cancer (mNSCLC). While the broader study population showed a 24.6% objective response rate (ORR), a specific biomarker-enriched subgroup achieved a 59.1% ORR, prompting the company to launch a new registrational-intent study focused on this precision approach.

Key Details

  • IOV-LUN-202 Trial Results: In the broader population of 69 patients with non-squamous mNSCLC, the trial demonstrated a 24.6% ORR. The company still plans to file a supplemental Biologics License Application (sBLA) for this indication in 2027.
  • Biomarker Subgroup Performance: A retrospective analysis identified a highly responsive subgroup defined by KRAS wild-type, HER2 wild-type, and smoking history. This group achieved a 59.1% ORR and accounted for over 75% of the total responses.
  • New Registrational Trial: Based on these findings, Iovance will initiate "POSITILITY," a prospective, biomarker-enriched cohort within the IOV-LUN-202 trial. The study has registrational intent and is scheduled to begin enrollment in November 2026.