The death of a study participant has prompted the FDA to place a clinical hold on an Iovance Biotherapeutics trial, the company said Dec. 22.
The trial is evaluatingLN-145, an experimental non-small cell lung cancer therapy in patients with metastatic disease. The therapy involves activating white blood cells from a patient's tumor to attack cancer cells. In a statement announcing the FDA hold, Iovance Biotherapeutics said the death may be related to a pre-conditioning regimen in which a patient receives a brief course of chemotherapy to prepare them for the treatment.
The company said enrollment in the trial will be paused during the hold, while patients previously treated with LN-145 will continue to be monitored.
"Iovance remains dedicated to addressing a significant unmet medical need for patients with advanced NSCLC, who have poor prognosis following disease progression and limited treatment options," Friedrich Graf Finckenstein, MD, chief medical officer at Iovance, said in a statement. "We will work with the FDA to safely resume enrollment in the IOV-LUN-202 trial as soon as possible."
An updated analysis on the treatment in November showed 71% of participants who had initially responded to treatment remained in response for at least six months, with treatment-emergent adverse events reported to date "consistent with the underlying disease and known adverse event profiles," according to Iovance.