FDA states that LN-145 in NSCLC is likely to receive accelerated approval

FDA states that LN-145 in NSCLC is likely to receive accelerated approval

Source – Iovance Biotherapeutics

The Phase II IOV-LUN-202 trial of LN-145 in patients with post-anti-PD-1 non-small cell lung cancer (NSCLC) carrying EGFR, ROS, or ALK gene mutations may meet the criteria for accelerated FDA approval, according to feedback provided by the FDA during a Type B pre-Phase III meeting with Iovance Biotherapeutics, the developer of LN-145.

In the initial analysis of the IOV-LUN-202 trial (NCT04614103), which included 23 patients with NSCLC treated with LN-145 tumor infiltrating lymphocyte (TIL) therapy, an objective response rate (ORR) of 26.1% was observed by RECIST v1.1. This included one complete response and five partial responses. The disease control rate was 82.6%, and although it is still early, the median duration of response (DOR) has not been reached, with responses ranging from 1.4 months to 9.7 months.

The safety profile of LN-145 was consistent with the underlying disease and the known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2.

Following regulatory discussions, the registrational IOV-LUN-202 trial is expected to enroll approximately 120 patients. The enrollment is projected to be completed in the second half of 2024.

Eligible patients for enrollment in the study are aged 18-70 and have a confirmed diagnosis of metastatic stage IV NSCLC without EGFR, ALK, or ROS genomic alterations. They should have documented radiographic disease progression after first-line therapy, at least one resectable lesion for TIL production, at least one measurable lesion, adequate organ and pulmonary function, and an ECOG performance status of 0-1. Patients with actionable mutations other than EGFR, ALK, or ROS genomic alterations will be allowed one additional line of therapy with the appropriate targeted therapy.

The primary endpoints of the study include ORR as assessed by the independent review committee in cohorts 1 and 2, and ORR by the investigator in cohorts 3 and 4. Secondary endpoints include safety, complete response rate, duration of response, disease control rate, progression-free survival, and core biopsies.

The study design of the IOV-LUN-202 trial may meet the requirements for accelerated approval of LN-145 TIL therapy for this specific patient population.

LN-145 is a ready-to-infuse TIL therapy that employs an autologous TIL manufacturing process initially developed by the National Cancer Institute and further optimized by Iovance for the treatment of patients with metastatic NSCLC.

In addition to the Phase II study, Iovance plans to hold discussions with the FDA this year regarding a randomized confirmatory trial of LN-145 for the treatment of frontline advanced NSCLC patients. This confirmatory trial is intended to be ongoing at the time of potential approval for patients with advanced post-anti-PD-1 NSCLC.

The FDA’s evaluation of Iovance’s Biologics License Application (BLA) for lifileucel in advanced melanoma is proceeding smoothly and according to schedule, with the Priority Review status intact. The Prescription Drug User Fee Act target action date for the BLA is set for November 25, 2023.

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