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US FDA Puts Clinical Hold on Iovance's Cancer Therapy Trial

Dec 27 (Reuters) - The U.S. health regulator has placed a clinical hold on Iovance Biotherapeutics' trial of its experimental cell therapy in lung cancer patients after a patient death, the company said on Wednesday, sending its shares down about 20%.

The company will pause enrollment in the non-small cell lung cancer (NSCLC) trial during the hold, while patients who were previously treated with the therapy will continue to be monitored.

The hold placed by the Food and Drug Administration (FDA) could potentially delay the therapy trial by months, analysts estimated, marking a setback to Iovance's quest to develop a new type of therapy for NSCLC, which is the most common form of the disease.

The therapy, called LN-145 TIL, which is also being developed to treat melanoma, uses white blood cells from a patient's tumor, modifies them and puts them back into the patient to help the immune system destroy cancer cells.

"Beyond the time it takes to actually resolve the clinical hold, it is possible that (the) hold results in recruitment losing momentum, potentially exacerbating the delay to data," said Truist analyst Asthika Goonewardene in a client note.

The company said the death was potentially related to a pre-conditioning regimen, where the patient receives a short course of chemotherapy to kill immune cells before being infused with Iovance's therapy.

The FDA's hold has no impact on any other trials conducted by the company, including a melanoma study, the company said.

The hold raises concerns that it could impact the marketing application in melanoma, Mizuho analyst Mara Goldstein said, though the company has indicated no impact.

The FDA had extended review of the skin cancer therapy from November to Feb. 2024, due to resource constraints.

Reporting by Christy Santhosh; Editing by Shailesh Kuber

Source: Reuters

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