Iovance Biotherapeutics (NASDAQ:IOVA) shares plunged after it revealed that the Food and Drug Administration (FDA) has imposed a clinical hold on its lung cancer therapy trial following the death of a patient.
The patient's death is potentially linked to a pre-conditioning regimen involving a short course of chemotherapy before receiving Iovance's LN-145 TIL therapy, according to reports.
The clinical hold prompts a pause in enrollment for the non-small cell lung cancer trial, though ongoing monitoring of previously treated patients will continue, Iovance said.
The company plans to collaborate with the FDA to safely resume enrollment at the earliest opportunity.
However, analysts at Jefferies estimate a potential delay of 90-120 days for review and restart. The hold is linked to a safety issue with the pre-conditioning regimen, and Jefferies suggests this could be a result of infection, among other factors.
Despite the setback, Iovance management remains confident in ongoing discussions with the FDA regarding the melanoma Biologics License Application (BLA). The PDUFA date for the melanoma review is set for February 24, 2024, and the company asserts it is on track, having navigated late-cycle review meetings and advanced into late-stage discussions on various aspects.
Average resolution time for clinical holds is approximately 90-119 days, Jefferies noted, with a success rate ranging from 50-60%, depending on the therapeutic area.
Shares of Iovance dropped over 21% on Wednesday morning in New York.