Iovance Biotherapeutics completed a preliminary analysis of the Phase II trial for its autologous tumour-infiltrating lymphocyte (TIL) therapy, Lifileucel (LN-145), in patients with metastatic non-small cell lung cancer (NSCLC) after a US Food and Drug Administration (FDA) review found the trial design may be suitable for accelerated approval.

The positive regulatory feedback was part of a Type B Pre-Phase III meeting and is based on Lifileucel’s use in patients with advanced and non-genomic mutated NSCLC who have received at least one line of an FDA-approved targeted therapy.

The Phase II trial for Lifileucel in metastatic NSCLC is planning an expected enrolment of 120 patients and a completion date in the second half of 2024. Iovance is also preparing to meet with the US FDA regarding a confirmatory trial of the autologous TIL in frontline advanced NSCLC patients.

Lifileucel received a biologics license application (BLA) in May 2023, with a Prescription Drug User Fee Act (PDUFA) target action date set for 25 November 2023.

GlobalData, the parent company of Pharmaceutical Technology, predicts Lifileucel to have global sales of $889m in 2029, with annual US sales reaching $281m in 2037.

Phase II preliminary data

A total of 23 patients were included in the data analysis from the open-label, non-randomised Phase II IOV-LUN-202 trial (NCT04614103) evaluating the safety and efficacy of Lifileucel in patients with metastatic anti-programmed cell death-ligand 1 (anti-PD-L1) NSCLC.

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The overall response rate was 26.1%, with one patient achieving a complete response while the other five only showed partial response.

The disease control rate was 82.6%. The median duration of response was not reached and ranged from 1.4+ to 9.7+ months.

No unexpected adverse events due to Lifileucel were reported. However, those relating to the underlying disease, non-myeloablative lymphodepletion, and interleukin-2 were observed during the study.

Other secondary endpoints of the trial include disease control rate, progression-free survival, and overall survival.

Lifileucel is also being evaluated for other solid tumour indications.