Updated December 29th, 2023 at 18:27 IST

FDA imposes clinical hold on Iovance's lung cancer trial after patient death, shares plummet

Iovance shares dropped 26.9% premarket amid concerns about LN-145 TIL therapy's pre-conditioning regimen.

Reported by: Business Desk
Representative | Image:Unsplash

Iovance Biotherapeutics' lung cancer treatment trial is facing a setback as the US Food and Drug Administration (FDA) has imposed a clinical hold following the death of a patient, the company announced on Wednesday. In response to a potential link with a pre-conditioning regimen involving chemotherapy before administering Iovance's LN-145 TIL therapy, shares of Iovance plummeted by 26.9 per cent in premarket trading.

Trial enrolment halt

The patient's death has prompted a pause in enrolment for the non-small cell lung cancer trial, with ongoing monitoring for individuals previously treated with the therapy. Non-small cell lung cancer, the most prevalent type, comprises over 80 per cent of all lung cancer cases.

Iovance is focused on collaborating with the FDA to ensure the safe resumption of enrolment at the earliest opportunity. Notably, this clinical hold does not impact other trials conducted by the company. Concurrently, the company is eagerly awaiting the FDA's decision on its experimental cell therapy lifileucel for the treatment of advanced melanoma, a type of skin cancer.


Complicating matters, the FDA extended the review timeline for Iovance's skin cancer therapy from November to February 2024, citing resource constraints. The company remains optimistic about addressing the concerns raised in the lung cancer trial and moving forward with its other endeavours.

(With Reuters Inputs)


Published December 27th, 2023 at 20:39 IST