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Iovance Biotherapeutics Announces Regulatory and Clinical Updates for Lifileucel in Melanoma
Positive FDA Feedback on Potency Assay Matrix to Support BLA Submission Further Defines Frontline Melanoma Strategy for Lifileucel in Combination with
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"Positive FDA Feedback on Potency Assay Matrix to Support BLA Submission Further Defines Frontline Melanoma Strategy for Lifileucel in Combination with Pembrolizumab SAN CARLOS, Calif., April 05, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback on April 1, 2022 regarding Iovance’s proposed matrix of potency assays for its upcoming Biologics License Application (BLA) for lifileucel in metastatic melanoma. Iovance received positive feedback from the FDA on both its potency assay matrix and its proprietary cell co-culture assay included in the potency assay matrix. Based on this response, Iovance expects to request a pre-BLA meeting in July 2022 and to complete a BLA submission for lifileucel by August 2022. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “The favorable feedback received from the FDA on our potency assays and assay matrix brings Iovance a step closer to our submission of a BLA for lifileucel in metastatic melanoma. We look forward to bringing lifileucel to the market quickly to offer melanoma patients a new option following anti-PD-1 therapy.” In addition, Iovance today announced plans to open a Phase III study for lifileucel in combination with pembrolizumab for the treatment of immune checkpoint inhibitor (ICI) naïve frontline metastatic melanoma in late 2022. Updated data from the combination cohort of lifileucel and pembrolizumab in ICI naïve patients (Cohort 1A in the IOV-COM-202 study, n=12) demonstrated an overall response rate (ORR) of 67%. Eight out of 12 patients had a confirmed objective response per RECIST 1.1, including three complete responses and five partial responses. Six of the eight responders had ongoing response at the time of the last data cut, and five responders had a duration of response of more than one year. The FDA previously granted Fast Track Designation for lifileucel in combination with pembrolizumab for the treatment of ICI naïve metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care. Management will host a conference call and live audio webcast to discuss these updates at 8:00 a.m...