Iovance Biotherapeutics, Inc. 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.

In addition, Iovance 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.