Iovance Biotherapeutics Announces Pause of NSCLC Trial

Iovance Biotherapeutics, a biotechnology company focused on producing tumor-infiltrating lymphocyte (TIL) therapies for cancer, has announced a clinical program update for LN-145 TIL therapy in the treatment of non-small cell lung cancer (NSCLC).

The US Food and Drug Administration (FDA) placed a clinical hold on the IOV-LUN-202 trial in December in response to a recently reported fatal event that was possibly related to the nonmyeloablative lymphodepletion preconditioning regimen.

The trial is assessing the use of LN-145 in patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) NSCLC without EGFR, ROS, or ALK genomic mutations and who had received at least 1 line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations.

Iovance announced that it will pause enrollment and the LN-145 TIL treatment regimen for new patients in IOV-LUN-202 during the clinical hold time. Patients previously treated with LN-145 in the trial will continue to undergo monitoring and will be followed according to the trial protocol. Patients who have already undergone tumor resection will continue to receive the LN-145 TIL treatment regimen with additional precautions and risk mitigations.

“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,” said Friedrich Graf Finckenstein, MD, chief medical officer of Iovance.