FDA places clinical hold on Iovance's LN-145 NSCLC trial after fatal adverse event

IOVANCE BIOTHERAPEUTICS, INC.

FDA placed clinical hold on IOV-LUN-202 on Dec 22, 2023, after a Grade 5 fatal SAE potentially linked to preconditioning.
Enrollment paused; previously treated patients monitored; those with tumor resection continue with risk mitigations.
No impact on other Iovance trials or lifileucel BLA; PDUFA date remains Feb 24, 2024.
Updated Nov 2023 data: 71% of confirmed responders had duration of response >6 months.
Iovance will work with FDA to resume enrollment safely.

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