FDA Places Hold on Trial Evaluating TIL Therapy in NSCLC

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The Food and Drug Administration stopped enrollment on a clinical trial evaluating LN-145 TIL for non-small cell lung cancer after a patient on the trial died.

The Food and Drug Administration (FDA) placed a clinical hold on the clinical trial evaluating the novel drug, LN-145 TIL, for patients with non-small cell lung cancer (NSCLC), according to a press release issued by Iovance Biotherapeutics, the manufacturer of the drug.

The decision to pause the IOV-LUN-202 trial came after an enrolled patient died, potentially from the non-myeloablative lymphodepletion pre-conditioning regimen.

IOV-LUN-202 is evaluating LN-145 TIL in patients with unresectable or metastatic NSCLC that progressed (got worse or stopped responding) on or after chemotherapy and an anti-PD-1 immunotherapy agent. To be eligible for the trial, patients cannot have an EGFR, ROS or ALK genomic mutation and must have received at least one line of an FDA-approved targeted therapy, if appropriate.

According to data published in the National Cancer Database, this patient population tends to have poorer outcomes.

Now that the FDA established a clinical hold on the trial, patients will not be able to enroll on IOV-LUN-202. Patients who were previously treated on the trial will continue to be monitored and followed according to the trial protocol, according to the press release. Patients on the trial who already underwent surgical removal of their cancer (resection), will continue to receive LN-145 TIL with additional precautions and risk mitigation.

Per the FDA’s website, the agency will place clinical holds on trials by telling the sponsor (pharmaceutical company developing the drug) via a clinical hold letter. The sponsor can then use a complete response to address the FDA’s reported issues with the trial. Once the complete response is received by the FDA, the agency then has 30 days to respond and potentially allow for the trial to resume.

Preliminary data from IOV-LUN-202 were published in July 2023, with an updated analysis published in November showing that additional ongoing responses and duration of response that lasted longer than six months occurred in 71% of patients with confirmed responses (the group of patients whose disease shrunk from treatment).

LN-145 TIL is a tumor-infiltrating lymphocyte (TIL) therapy that works by isolating TILS, which can find and fight cancer. These TILS are further expanded and then infused back into the patient, sparking an immune response against tumor cells.

To date, more than 100 patients with lung cancer have been treated with LN-145, with trial data reporting side effects that were consistent with NSCLC and known toxicities from this type of treatment.

“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. We will work with the FDA to safely resume enrollment in the IOV-LUN-202 trial as soon as possible,” Dr. Friedrich Graf Finckenstein, chief medical officer at Iovance, said in the press release.

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