IOVA - Iovance receives FDA feedback on lung cancer candidate
2023-07-10 07:25:23 ET
Citing FDA feedback, Iovance Biotherapeutics ( NASDAQ: IOVA ) announced Monday that the design for the company’s ongoing IOV-LUN-202 trial for the lung cancer candidate LN-145 could be acceptable for a potential accelerated approval.
The FDA indicated its views at a Type B Pre-Phase 3 meeting on LN-145, a tumor-infiltrating lymphocyte (TIL) targeted at patients with non-small cell lung cancer (NSCLC).
IOV-LUN-202 is designed to study LN-145 as a late-line option for patients with NSCLC who have progressed on or after frontline chemo- and anti-PD1-therapy.
According to Iovance ( IOVA ), an early analysis involving 23 NSCLC patients from the trial indicated an objective response rate of ~26% (one complete response and five partial responses) and a disease control rate of ~83%.
The duration of response ranged from 1.4+ months to 9.7+ months, and the trial has yet to reach the median DOR.
The company intends to enroll about 120 patients for IOV-LUN-202, and the enrollments are expected to conclude in H2 2024.
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Iovance receives FDA feedback on lung cancer candidate