FDA slaps clinical hold on Iovance's LN-145 trial

US biotech Iovance Biotherapeutics (Nasdaq: IOVA) saw its shares drop more than 20% on Tuesday, after it revealed a setback with its clinical program for LN-145 TIL therapy in non-small lung cancer (NSCLC), but jumped back 18.7% to $8.58 on Thursday.

Iovance said that the US Food and Drug Administration (FDA) has placed a clinical hold on the IOV-LUN-202 trial, in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen.

IOV-LUN-202 is investigating LN-145 in patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations.