Iovance Biotherapeutics: FDA lifts partial clinical hold on IOV-LUN-202 trial

Iovance Biotherapeutics announced that the U.S. FDA lifted a partial clinical hold placed on the registrational IOV-LUN-202 trial investigating LN-145 TIL cell therapy in non-small cell lung cancer. In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring. Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202. The IOV-LUN-202 trial is investigating LN-145 in patients with advanced NSCLC without EGFR, ROS or ALK genomic mutations who were previously treated with chemotherapy and anti-PD-1 therapy and at least one line of an approved targeted therapy if indicated by other actionable tumor mutations. Iovance expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025. Preliminary data from the IOV-LUN-202 trial support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies. Initial preliminary data were reported in July of 2023. An updated analysis in November of 2023 showed additional ongoing responses and duration of response greater than six months for 71% of the confirmed responders in the trial.