Iovance reports 24.6% response rate for lifileucel in lung cancer trial
IOVA•Iovance Biotherapeutics reported a 24.6% response rate for lifileucel in a Phase 2 trial for previously treated non-squamous metastatic lung cancer. A biomarker-selected subgroup showed stronger responses in a retrospective analysis.
1. Trial results and next steps
Updated Phase 2 results showed lifileucel’s activity remained consistent with earlier findings in previously treated non-squamous metastatic lung cancer. A retrospective analysis found stronger responses in a biomarker-selected subgroup, which the company said supports a targeted development strategy requiring prospective evaluation.
2. Planned studies and filing
Enrollment in the biomarker-enriched POSITILITY cohort is expected to begin in November 2026, targeting a potential registration pathway subject to FDA feedback. Iovance plans to submit a supplemental biologics license application for lifileucel in non-squamous metastatic non-small-cell lung cancer in 2027, and expects the frontline OPTILISM trial to begin that year.
