Key Highlights

  • Updated Phase 2 IOV-LUN-202 data showed a 24.6% overall response rate in previously treated non-squamous mNSCLC.
  • Response rates reached 43.3% in patients with KRAS wild-type tumors.
  • A retrospectively defined smoker-enriched subgroup lacking KRAS and HER2 mutations showed a 59.1% response rate.
  • Broader study data is expected to support an anticipated sBLA submission in 2027, with prospective validation underway in the new POSITILITY cohort.

Response Rates Vary by Biomarker Subgroup

Iovance Biotherapeutics presented updated results from its Phase 2 IOV-LUN-202 trial, showing a 24.6% overall response rate among previously treated patients with non-squamous metastatic non-small cell lung cancer. The data showed meaningfully higher response rates within specific biomarker defined subgroups, reaching 43.3% in patients with KRAS wild-type tumors and 59.1% in a retrospectively defined subgroup of smokers lacking both KRAS and HER2 mutations.

Path Toward Regulatory Submission

Iovance said data from the broader IOV-LUN-202 study is expected to support an anticipated submission of a supplemental Biologics License Application in 2027. The company cautioned that the subgroup findings described above were identified retrospectively, meaning they were observed after the fact rather than defined before the trial began. To build on these findings, the company has launched a new cohort, POSITILITY, designed to prospectively validate the biomarker strategy identified in the current analysis before it is used to support a broader regulatory filing.

What were the key results from the IOV-LUN-202 trial?

The trial showed a 24.6% overall response rate in previously treated non-squamous mNSCLC, with higher rates of 43.3% in KRAS wild-type patients and 59.1% in a smoker-enriched subgroup lacking KRAS and HER2 mutations.

What is the POSITILITY cohort?

It is a new study cohort Iovance has initiated to prospectively validate the biomarker strategy identified in the IOV-LUN-202 trial ahead of an anticipated 2027 regulatory submission.