Iovance Biotherapeutics reported updated results from a midstage trial of lifileucel in previously treated, non-squamous metastatic non-small-cell lung cancer (mNSCLC), and outlined a new strategy to select patients using tumor biomarkers. The results support the company’s plan to seek an expanded U.S. approval for lifileucel in this cancer type in 2027.
The most pronounced response rates came from a subgroup identified through retrospective analysis. Iovance plans to test that biomarker-based approach prospectively in a new cohort designed with the goal of supporting a future registration.
Key details
-
Overall response rate was 24.6%: As of an Oct. 14, 2026 data cutoff, 17 of 69 patients in the trial’s first two cohorts responded. That result is consistent with the previously reported 25.6% response rate among 39 patients.
-
Most responses were confirmed, but review is ongoing: The 17 responses included 15 confirmed responses and two partial responses awaiting confirmation. Independent review of radiology assessments is continuing.
-
The new biomarker-defined subgroup had a higher response rate: The retrospective analysis defined the subgroup as patients whose tumors were KRAS wild-type and HER2 wild-type and who were current or former smokers. It included 22 of the 69 patients and accounted for 13 of the 17 responses, for a 59.1% response rate.
-
KRAS status was also associated with differing response rates: Iovance reported a 43.3% response rate in patients with KRAS wild-type disease, compared with 11.4% in those with KRAS-mutant disease.
-
The subgroup analysis was not used to select patients for the existing cohorts: Patients in Cohorts 1 and 2 were enrolled without prospective selection using the new biomarker criteria. Iovance plans to evaluate the approach prospectively in POSITILITY, a new biomarker-enriched cohort within the Phase 2 trial, with enrollment expected to begin in November 2026.
-
The broader trial is nearing completion: Iovance expects the final dataset for Cohorts 1 and 2 to include about 80 patients. The company plans to seek a supplemental biologics license for lifileucel in non-squamous mNSCLC in 2027 and said discussions with U.S. regulators are ongoing.
-
Safety and durability were described as consistent with earlier reports: The trial uses a reduced-dose lymphodepletion regimen, which Iovance said has improved the overall safety profile.
What the results mean
The new strategy rests on a retrospective analysis of a relatively small subgroup, rather than on prospective selection in the existing cohorts. POSITILITY is intended to test whether selecting patients by these biomarkers can reproduce the higher response rate. The planned 2027 application for broader non-squamous mNSCLC, meanwhile, is based on the ongoing Cohorts 1 and 2 program.