Iovance Biotherapeutics (IOVA) Study update summary

Updated IOV-LUN-202 results

• As of Oct. 14, 2026, lifileucel achieved a 24.6% ORR (17/69) in previously treated non-squamous mNSCLC; results were consistent with the prior 39-patient dataset.

• Responses included 15 confirmed responses and 2 unconfirmed partial responses pending confirmation; both complete responses were in KRAS wild-type patients.

• Response durability and safety were consistent with prior reports; reduced-dose lymphodepletion improved the overall safety profile.

• Cohorts 1 and 2 added 30 patients to the earlier dataset; enrollment was nearing completion, with ~80 patients expected in the final dataset.

Biomarker findings

• KRAS wild-type patients had a 43.3% ORR (13/30), versus 11.4% (4/35) in KRAS-mutant patients.

• The KRASWT/HER2WT/current-or-former-smoker subgroup had a 59.1% ORR (13/22), accounting for 13 of 17 responses; 12 responses were confirmed and 1 was unconfirmed.

• KRASWT/HER2WT patients had a 52.0% ORR (13/25); no relationship between PD-L1 status and TIL response was observed in lung cancer.

• Biomarker-enriched criteria are estimated to apply to ~45% of U.S. non-squamous metastatic NSCLC diagnosed annually.

Development and regulatory plans

• POSITILITY, a prospective biomarker-enriched cohort with registrational intent, is expected to begin enrollment in November 2026 across more than 70 existing sites and include PD-L1-positive and PD-L1-negative patients.

• Cohorts 1 and 2 support a planned 2027 sBLA; FDA discussions, independent review committee assessments and confirmatory-trial preparation are ongoing.

• Filing is targeted for 2027 after the usual six months of follow-up from the last response; review and potential approval are expected in late 2027–2028.

• A final data cut was expected in early 2027, with further biomarker analyses and congress presentations planned, including during H1 2027.