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Iovance announced its positive regulatory and clinical updates in regard to its registrational single-arm Phase II IOV-LUN-202 trial in anti-programmed cell death-ligand 1 (post-anti-PD-1) NSCLC and has since completed a preliminary analysis of the IOV-LUN-202 trial after the FDA found the trial design acceptable for accelerated approval.
Iovance Biotherapeutics is focused on innovating, developing and delivering novel polyclonal tumor-infiltrating lymphocyte (TIL) therapies for patients with cancer. Its lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer.
The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors.
At a Type B Pre-Phase III meeting, the FDA gave positive regulatory feedback that the design of the IOV-LUN-202 trial may be accepted for accelerated approval of LN-145 TIL therapy for patients who have progressed on/after chemotherapy and anti-PD-1 therapy for advanced non-small cell lung cancer (NSCL). The therapy will be intended for NSCL patients without epidermal growth factor (EGFR), reactive oxygen species (ROS) or anaplastic lymphoma kinase (ALK) genomic mutations having received at least one line of an FDA-approved target therapy if indicated by other actionable tumor mutations.
Based on the regulatory discussions, Iovance plans to enroll approximately 120 patients into the registrational IOV-LUN-202 trial. The enrollment is anticipated to be complete during the second half of 2024. Iovance is also preparing to meet with the FDA to discuss a randomized confirmatory trial of LN-145 in frontline advanced NSCLC patients.
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The Phase II preliminary data, in summary:
- 23 patients were included in an open-label, non-randomized Phase II IOV-LUN-202 trial (NCT04614103) to evaluate the saftey and efficacy of lifileucel in patients with metastatic anti-PD-1 NSCLC.
- There was 26.1% overall response rate, with one patient achieving a complete response whilst 5 other patients demonstrated partial response
- 82.6% disease control rate
- The median duration of response was not reached and ranged from 1.4+ months to 9.7+ months
- No unexpected adverse events due to Lifileucel were reported
The Lifileucel BLA submission remains on track in advanced melanoma with a BLA date of November 25, 2023.
Source: Iovance Biotherapeutics, Inc.
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