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Iovance Biotherapeutics Receives Positive FDA Feedback Supporting Lifileucel BLA Submission

NEW YORK – Iovance Biotherapeutics said after markets closed on Monday that it has received positive feedback from the US Food and Drug Administration on the proposed potency assay for its autologous tumor infiltrating lymphocyte (TIL) therapy lifileucel.

The FDA's feedback will allow the firm to advance lifileucel development, and Iovance now anticipates filing a biologics license application for the TIL therapy in metastatic melanoma by August.

The San Carlos, California-based firm is optimistic about lifileucel's approval based on positive clinical trial data, and the experience of patients who have received the therapy in a research context through the National Cancer Institute, MD Anderson Cancer Center, and the Moffitt Cancer Center. However, the company faced setbacks with regulators with regard to the potency assay it had proposed using to measure the product's consistency and ensure it will have activity when infused in patients.

According to the company, the FDA has responded positively to its updated strategy, including both the matrix approach Iovance is using to measure potency with multiple aspects of the product and the cell co-culture assay included in the matrix.

"We've got very good alignment with the FDA [and] are feeling very confident about the BLA at this point," Iovance Interim CEO Fred Vogt said during a conference call to discuss the announcement Wednesday morning.

Iovance is planning to request a pre-BLA meeting with the FDA in July before filing the application in August.

Separately on Tuesday, Iovance announced that it plans to begin a Phase III clinical trial evaluating lifileucel combined with Merck's Keytruda (pembrolizumab) in the first-line treatment setting for metastatic melanoma. The trial, which will enroll patients who have not received prior immune checkpoint inhibitors, is expected to begin later this year.

The decision to explore this strategy in a Phase III trial is supported by positive data from a small cohort within a larger lifileucel basket trial. In that cohort of 12 patients not previously treated with immune checkpoint inhibitors, eight patients had a confirmed objective response to lifileucel and three patients had complete responses. The FDA granted fast-track status to the TIL therapy-Keytruda combination.