Iovance Reports Updated IOV-LUN-202 Results and Adds Precision TIL Strategy for Second-Line Metastatic Non-Small-Cell Lung Cancer (mNSCLC)
Key Highlights
- ➤IOV-LUN-202 broader population delivered 24.6% ORR in 69 non-squamous mNSCLC patients
- ➤KRAS wild-type tumors achieved 43.3% ORR versus 11.4% for KRAS-mutant disease
- ➤Biomarker-enriched subgroup reached 59.1% ORR, including both complete responses
- ➤Iovance plans 2027 sBLA submission for lifileucel in non-squamous mNSCLC
- ➤POSITILITY prospective biomarker-enriched cohort begins enrollment in November 2026
Expert Statements
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance
“These findings are reshaping how we develop TIL therapy for mNSCLC”
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance
“The expanded dataset reinforces the activity of lifileucel in previously treated disease, while the concentration of responses in KRAS wild-type tumors points to a more precision approach to patient selection.”
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance
“In the enriched subgroup, nearly six in ten patients responded, including two complete responses.”
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance
“We believe these insights could expand lifileucel’s potential as a one-time treatment for mNSCLC, with a best-in-class profile compared to other therapies in development.”
Wayne Rothbaum, co-Chair of the Scientific Committee of Iovance’s Board of Directors
“Tumor-reactive T cells need recognizable targets and a tumor microenvironment that supports a sustained antitumor response.”
Wayne Rothbaum, co-Chair of the Scientific Committee of Iovance’s Board of Directors
“The response pattern in IOV-LUN-202 provided a clinical rationale for testing how tumor biology can guide TIL therapy.”
Wayne Rothbaum, co-Chair of the Scientific Committee of Iovance’s Board of Directors
“Starting with KRAS status, and refining selection through HER2 status and smoking history, we identified a highly responsive mNSCLC subgroup where TIL biology converges with an immuno-reactive tumor microenvironment.”
Wayne Rothbaum, co-Chair of the Scientific Committee of Iovance’s Board of Directors
“We now aim to translate these novel findings into a precision development plan utilizing KRAS-based stratification, designed to identify patients most likely to benefit from lifileucel therapy.”
24.6% Objective Response Rate (ORR) in 69 Patients with Non-Squamous mNSCLC, Consistent with Previously Reported Results
IOV-LUN-202 Cohorts 1 and 2 Are Completing Enrollment and Support a Planned Supplemental Biologics License Application (sBLA) for Lifileucel in Non-Squamous mNSCLC in 2027
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