FDA lifts clinical hold on Iovance's IOV-LUN-202 NSCLC trial; enrollment to resume

IOVANCE BIOTHERAPEUTICS, INC.

FDA cleared Iovance to resume patient enrollment in registrational IOV-LUN-202 trial for LN-145 TIL therapy in NSCLC.
Additional safety and monitoring measures developed with FDA and independent data monitoring committee.
Iovance expects to complete enrollment of ~120 patients in registrational cohorts by 2025.
Updated Nov 2023 data showed 71% of confirmed responders had duration of response >6 months.
Initial preliminary data from July 2023 supported durable responses over available second-line chemotherapies.

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