On July 10, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported positive regulatory and clinical updates related to its registrational single-arm Phase 2 IOV-LUN-202 trial in post-anti-PD-1 NSCLC (Press release, Iovance Biotherapeutics, JUL 10, 2023, View Source [SID1234633135]).

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NSCLC Regulatory and Clinical Update:

At a Type B Pre-Phase 3 meeting held between Iovance and the U.S. Food and Drug Administration (FDA), the FDA provided positive regulatory feedback that the design of the IOV-LUN-202 trial may be acceptable for accelerated approval of LN-145 TIL therapy for patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) 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. This recent data cut1 included 23 NSCLC patients treated with LN-145. An ORR of 26.1% by RECIST v1.1 (n=6, one complete response and five partial responses) was observed, with a disease control rate of 82.6%. While still early on study, 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. Based on the regulatory discussions, Iovance plans to enroll a total of approximately 120 patients into the registrational IOV-LUN-202 trial. Enrollment is expected to be complete during the second half of 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. This confirmatory trial in frontline advanced NSCLC is expected to be well underway at the time of a potential approval in advanced post-anti-PD-1 NSCLC.

Lifileucel BLA Submission on Track in Advanced Melanoma:
The FDA’s Priority Review of Iovance’s Biologics License Application (BLA) for lifileucel in advanced melanoma remains on track and continues to progress well. The Prescription Drug User Fee Act target action date for the BLA is November 25, 2023.

Data cut date of July 6, 2023.