Clinical trialsCompany release

Iovance reports 24.6% lifileucel response rate in lung cancer, plans biomarker-enriched cohort

🇺🇸 Iovance Biotherapeutics, Inc. (IOVA) · Thu 29 Oct 2026

Updated Phase 2 data show a markedly higher response rate in KRAS wild-type NSCLC, and the company is discussing a 2027 sBLA with the FDA.

Iovance Biotherapeutics has released updated Phase 2 IOV-LUN-202 results for lifileucel in previously treated non-squamous metastatic non-small cell lung cancer (NSCLC). With a data cutoff of 14 October 2026, 17 of 69 patients responded, an overall response rate of 24.6%.

Response varied sharply by KRAS status. Patients with KRAS wild-type tumours had a response rate of 43.3%, against 11.4% in those with KRAS-mutant disease. The company has not provided further detail in the material available to VigiEye.

Iovance said it plans to file a supplemental biologics licence application (sBLA) in 2027 and is in ongoing discussions with the US Food and Drug Administration. It will start enrolling a biomarker-enriched cohort, called POSITILITY, in November 2026; the company describes the cohort as registrational-intent.

A separate frontline trial, OPTILISM, is also planned for 2027.

What it means for your team

  • The KRAS-based split suggests a biomarker-driven population may shape any future lung cancer filing; regulatory teams should watch how the FDA views the enriched cohort.
  • The planned 2027 sBLA depends on ongoing FDA discussions, and no agreement on the registrational package has been disclosed.
  • Market-access teams should note that any eventual label could hinge on KRAS testing, which would bring diagnostic pathways into reimbursement planning.
  • Because the data come from a company announcement of a single-arm Phase 2 study, the findings should be treated as preliminary.

Company's press release (SEC filing): Iovance Biotherapeutics, Inc. ↗

Article written by VigiEye from the official source (Iovance Biotherapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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