The US Food and Drug Administration (FDA) has placed a hold on Iovance Biotherapeutics’ IOV-LUN-202 clinical trial of LN-145 tumour infiltrating lymphocyte (TIL) therapy to treat non-small lung cancer (NSCLC).
The clinical hold, which is effective from 22 December this year, is in response to a case of Grade 5 (fatal) serious adverse event reported in the trial.
This adverse event is said to be potentially linked to the non-myeloablative lymphodepletion pre-conditioning treatment.
The IOV-LUN-202 trial is designed to assess LN-145 in treating NSCLC patients who have advanced on or following chemotherapy and anti-PD-1 therapy.
Subjects in the trial should have advanced (unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations and received treatment with a minimum of one FDA-approved targeted therapy to be part of the trial.
During the clinical hold, Iovance will pause enrolment and dosing with LN-145 TIL treatment regimen in new subjects.
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However, patients who have received the treatment will continue to be observed and those who have undergone resection of the tumour will be given LN-145 with further precautions.
In an updated analysis reported in November this year, LN-145 demonstrated to offer ongoing responses and duration of response for more than six months in 71% of the responders.
These findings back the potential of single LN-145 TIL regimen to offer lasting responses versus the existing second-line chemotherapies for advanced NSCLC.
The latest clinical hold does not affect other trials of the company nor the priority review by the FDA for a biologics license application for lifileucel in advanced melanoma, the company noted.
A decision on the approval for this therapy is expected on 24 February next year.
Iovance chief medical officer Friedrich Graf Finckenstein said: “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 enrolment in the IOV-LUN-202 trial as soon as possible.”