Lifileucel Hits 24.6% ORR in NSCLC; Biomarker Subgroup Reaches 59.1%
IOVA has more than doubled off its 52-week low of $1.76.
Summary
Iovance reported a 24.6% objective response rate in 69 previously treated non-squamous metastatic NSCLC patients, with a 59.1% ORR in a KRAS WT/HER2 WT/smoker-enriched subgroup. KRAS status looks like the selector: 43.3% ORR in KRAS wild-type versus 11.4% in KRAS mutant. That is the first real evidence the TIL platform travels beyond melanoma, and it comes after the October 23 melanoma cohort data and the October 26 sarcoma pilot readout. The regulatory path is set but not near: cohorts 1 and 2 are finishing enrollment with a planned sBLA in 2027, and the biomarker-enriched POSITILITY cohort begins enrolling in November 2026. A small frontline combination cohort showed 85.7% ORR in 7 patients — too few to lean on, but it supports the 1L program. The stock is up sharply since the September 29 guidance raise to $410-$420 million, so this adds pipeline value rather than fixing the near-term revenue story.
At the time of this announcement, IOVA was trading at $13.13 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6.7B. The 52-week trading range was $1.76 to $15.37. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.