Following a patient death in the phase 2 IOV-LUN-202 trial, the FDA has issued a clinical hold.
The phase 2 IOV-LUN-202 trial investigating the LN-45 TIL therapy for the treatment of patients with advanced NSCLC has been placed on clinical hold by FDA following a the death of a patient death. The fatal AE is potentially related to the non-myeloablative lymphodepletion preconditioning regimen.1
“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, in a press release.
Data from a preliminary analysis was announced in July 2023. The findings reported an objective response rate (ORR) of 26.1% (n = 6) and a disease control rate (DCR) of 82.6%. There were 5 partial responses and 1 complete response. The duration of response (DOR) was not yet met.2
In other reported clinical trial results, treatment-emergent AEs have been consistent with disease progression, as well as and the known safety profiles of non-myeloablative lymphodepletion and interleukin-2, according to Iovance.1
IOV-LUN-202 has an estimated enrollment of 170 patients with histologically or pathologically confirmed metastatic stage IV NSCLC without EGFR, ROS, or ALK mutations. Patients must have had disease progression following at least 1 prior line of therapy. The primary end point is ORR, and the secondary end points include complete response rate, DOR, DCR, progression-free survival, overall survival, incidence of AEs, and core biopsies.3
Four cohorts were incorporated in the study. These included:
There is also an experimental retreatment cohort of patients from any of the 4 core cohorts who were previously treated with LN-45.
Iovance Biotherapeutics, LN-45’s manufacturer, is also the manufacturer of lifileucel. The priority review of the biologics license application for lifileucel (LN-144 ) is not affected, and the Prescription Drug User Fee Act target date of February 24, 2024, is still in place.
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