FDA places hold on trial of cell therapy for lung cancer after patient death
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The FDA placed a clinical hold on a trial designed to evaluate a novel cell therapy for non-small cell lung cancer after one study participant died.
LN-145 (Iovance Biotherapeutics) is an autologous tumor-infiltrating lymphocyte therapy.
The IOV-LUN-202 trial is designed to investigate the agent for patients with advanced NSCLC without EGFR, ROS or ALK mutations whose disease progressed on or after chemotherapy and an anti-PD-1 therapy.
The FDA placed a clinical hold on the trial on Dec. 22 after a study participant experienced a serious adverse event potentially related to the nonmyeloablative lymphodepletion preconditioning regimen, according to an Iovance Biotherapeutics-issued press release.
Iovance paused enrollment and the LN-145 treatment regimen for new patients. Study participants who already received treatment will continue to be monitored per trial protocol, and those who already underwent tumor resection will continue to receive the LN-145 regimen with additional risk mitigations and precautions, according to the release.
Results as of November showed 71% of study participants who had achieved confirmed response to treatment remained in response for at least 6 months.
“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,” Friedrich Graf Finckenstein, MD, chief medical officer of Iovance, said in the release.
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