Iovance's Update Provides Reassurance With Upcoming Lifileucel's FDA Action Date, Analyst Says

Iovance Biotherapeutics Inc IOVA announced regulatory and clinical updates related to its registrational single-arm Phase 2 IOV-LUN-202 trial in post-anti-PD-1 non-small cell lung cancer (NSCLC).

At a Type B Pre-Phase 3 meeting, the FDA said that the design of the IOV-LUN-202 trial might be acceptable for accelerated approval of LN-145 TIL therapy for lung cancer patients.

The application covers patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced NSCLC without EGFR, ROS, or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations. 

Based on this FDA feedback, Iovance completed a preliminary analysis of the IOV-LUN-202 trial. 

The recent data cut included 23 NSCLC patients treated with LN-145. 

An ORR of 26.1% (n=6, one complete response and five partial responses) was observed, with a disease control rate of 82.6%. The median duration of response (DOR) was not reached. 

The DOR ranged from 1.4+ months to 9.7+ months. Treatment-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2. 

Iovance plans to enroll approximately 120 patients into the registrational IOV-LUN-202 trial. Enrollment is expected to be complete during 2H 2024. 

As previously announced, Iovance is also preparing to meet with the FDA this year to discuss a randomized confirmatory trial of LN-145 in frontline advanced NSCLC patients. 

The FDA's Priority Review of the marketing application for lifileucel in advanced melanoma remains on track and continues progressing well. The target action date is November 25.

HC Wainwright reiterates its Buy rating and $38 price target. The analyst notes FDA's acceptance of the lifileucel's rolling BLA is a significant milestone for the company. 

It says that as there are no FDA-approved therapies in this treatment setting, the FDA's feedback on the application's quality, and the absence of an AdCom, lifileucel is expected to be approved with a favorable label in advanced melanoma as anticipated. 

Price Action: IOVA shares are up 6.31% at $7.24 on the last check Monday.