The FDA has provided feedback regarding Iovance Biotherapeutics Inc's (NASDAQ:IOVA) proposed matrix of potency assays for its upcoming Biologics License Application (BLA) for lifileucel in metastatic melanoma.
- The company received positive feedback from the FDA on 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 complete a BLA submission for lifileucel by August 2022.
- Related: Iovance's Lifileucel Combo Shows Encouraging Response Rates In Advanced Cancers.
- Additionally, Iovance plans to open a Phase 3 study for lifileucel combined with Merck& Co Inc's (NYSE:MRK) Keytruda (pembrolizumab) for 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 demonstrated an overall response rate (ORR) of 67%.
- Eight out of 12 patients had a confirmed objective response, including three complete and five partial responses.
- Six of the eight responders had an ongoing response at the time of the last data cut, and five responders had a duration of response of more than one year.
- Price Action: IOVA shares are up 4.11% at $17.24 during the premarket session on the last check Wednesday.
