Iovance Biotherapeutics Inc (IOVA)

[jondoeuk]

Citing feedback, the company announced that the design for the 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 III meeting. 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 the company, an early analysis involving 23 NSCLC patients from the trial indicated an ORR of ~26% and a DCR of ~83%. The duration of response ranged from 1.4+ months to 9.7+ months, 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.