Iovance Biotherapeutics, Inc. issued an updated report on October 29, 2026, detailing results from the Phase 2 IOV-LUN-202 trial for lifileucel in previously treated non-squamous metastatic non-small-cell lung cancer (mNSCLC). As of a data cutoff on October 14, 2026, the trial had enrolled 69 patients. The overall objective response rate (ORR) was 24.6%, with 17 responses reported, consisting of 15 confirmed responses and two unconfirmed partial responses.
A retrospective analysis identified a biomarker-enriched subgroup defined by specific tumor characteristics. This subgroup included patients who were KRAS wild-type, HER2 wild-type, and had a current or former smoking history. This group represented 22 of the 69 patients but accounted for 13 of the 17 total responses, resulting in an ORR of 59.1%. The company noted that both complete responses occurred within this enriched subgroup.
Further analysis of the broader population revealed a significant difference in response based on KRAS status. In the 30 patients with KRAS wild-type tumors, the ORR was 43.3%. Conversely, in the 35 patients with KRAS-mutant tumors, the ORR was 11.4%. Iovance stated that these findings provide the clinical foundation for a precision TIL strategy.
As a result of these results, the company announced the launch of POSI TIL ITY, a first-in-class, prospective, biomarker-enriched cohort study. Enrollment for this trial is scheduled to begin in November 2026 at over 70 existing IOV-LUN-202 sites. The company also plans to initiate OP TIL ISM, a frontline trial in biomarker-enriched non-squamous mNSCLC, in 2027. The company expects to submit a supplemental Biologics License Application (sBLA) for lifileucel in non-squamous mNSCLC in 2027.
