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Iovance Resumes Enrollment in NSCLC TIL Therapy Trial After FDA Lifts Clinical Hold

NEW YORK – Iovance Biotherapeutics said on Monday that the US Food and Drug Administration has lifted the clinical hold on Iovance's Phase II clinical trial evaluating autologous tumor-infiltrating lymphocyte (TIL) therapy LN-145 in non-small cell lung cancer.

The FDA had put a hold on the IOV-LUN-202 clinical trial in late 2023 after one of the patients on the trial died due to a serious adverse event following treatment.

Iovance has since collaborated with the FDA and an independent data monitoring committee to develop additional safety measures and monitoring for the trial, according to the San Carlos, California-based firm.

Through the clinical trial, Iovance is investigating LN-145 in patients with advanced NSCLC who've previously received chemotherapy, anti-PD-1 checkpoint inhibitor therapy, and at least one line of targeted therapy if they're eligible. The trial is only enrolling NSCLC patients who do not harbor EGFR, ROS, or ALK mutations.

Iovance expects to complete enrollment of roughly 120 patients during 2025 and has said that, so far, preliminary data from the trial support the treatment's benefit.

The news comes just weeks after the firm finally garnered regulatory approval for its autologous TIL therapy Amtagvi (lifileucel) in metastatic melanoma, opening the doors to new areas of autologous cell therapy development in solid tumors.