Is a Patient Death Impacting Iovance Biotherapeutics' Lung Cancer Trial?

Iovance Biotherapeutics, a biotechnology company, has encountered a setback in its clinical trial for an experimental cell therapy in lung cancer patients. The U.S. health regulator has placed a clinical hold on the trial following the death of a patient. As a result, Iovance Biotherapeutics' shares have dropped approximately 20%.

During the clinical hold, enrollment in the non-small cell lung cancer (NSCLC) trial will be paused. However, patients who have previously received the therapy will continue to be monitored. The hold comes after a patient death that was potentially linked to the pre-conditioning regimen, which involves administering a short course of chemotherapy to eliminate immune cells before the infusion of Iovance's therapy.

Analysts have expressed concerns about the impact of the hold on the trial. Truist analyst Asthika Goonewardene noted that besides the time required to resolve the clinical hold, there is a possibility of recruitment losing momentum, potentially leading to further delays in data collection.

Iovance Biotherapeutics clarified that the clinical hold imposed by the FDA does not affect any other trials being conducted by the company, including a study focused on melanoma. However, the hold has raised concerns about the potential impact on the marketing application for the melanoma therapy. Mizuho analyst Mara Goldstein highlighted this concern, although Iovance Biotherapeutics has stated that there will be no impact on the melanoma study.

It is worth noting that the FDA had already extended the review period for Iovance Biotherapeutics' skin cancer therapy from November to February 2024 due to resource constraints. The clinical hold adds another layer of uncertainty to the timeline for the therapy's potential approval.

This development underscores the challenges faced by Iovance Biotherapeutics in advancing its cell therapy for lung cancer and raises questions about the implications for future trials and the company's overall strategy.