Iovance gets FDA positive feedback for TIL therapy in NSCLC; 26.1% ORR in 23 patients

IOVANCE BIOTHERAPEUTICS, INC.

FDA Type B meeting supports IOV-LUN-202 trial design for accelerated approval of LN-145 in post-anti-PD-1 advanced NSCLC.
Preliminary data cut shows 26.1% ORR (6/23 patients) with one complete response and five partial responses; disease control rate 82.6%.
Plans to enroll ~120 patients in registrational trial; enrollment expected complete H2 2024.
Lifileucel BLA for advanced melanoma remains on Priority Review; PDUFA date Nov 25, 2023.

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