Iovance Biotherapeutics, Inc. announced a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen. IOV-Lun-202 is investigating LN-145 in patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) non-small cell lung cancer (NSCLC) without EGFR, ROS or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations.

These patients have a poor prognosis, limited treatment options, and a real-world overall survival of less than six months. The clinical hold for IOV-LUN- 202 has no impact on any other Iovance clinical trials and is independent of the FDA's Priority Review of the biologics license application (BLA) for lifileucel in advanced melanoma.