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Iovance Randomizes First Melanoma Patient in Frontline TIL Therapy, Keytruda Trial

NEW YORK – Iovance Biotherapeutics on Thursday said it has randomized the first advanced melanoma patient in its Phase III trial of lifileucel plus Merck's Keytruda (pembrolizumab) versus Keytruda alone.

The TILVANCE-301 trial pits the autologous tumor-infiltrating lymphocyte (TIL) therapy combination against the checkpoint inhibitor in patients with unresectable or metastatic melanoma who have not received prior therapy for advanced disease. The trial will randomize roughly 670 patients to one of the two arms, and patients whose cancers progress on the Keytruda monotherapy arm will be allowed to receive TIL therapy.

Iovance is seeking accelerated approval from the US Food and Drug Administration for lifileucel in melanoma patients who previously received checkpoint inhibitors. Data from TILVANCE-301 could allow Iovance to produce confirmatory data to convert the accelerated approval to a full approval, and it could support regulatory filings for lifileucel in the frontline treatment setting, the company said.

The San Carlos, California-based firm has been trying to secure FDA approval for lifileucel in the later-line setting for several years, and recently announced that the agency accepted its application and is expected to issue a decision in November 2023.

"TILVANCE-301 is expected to be well underway at the time of potential accelerated approval in this initial indication," Iovance Chief Medical Officer Friedrich Graf Finckenstein said in a statement. "This trial may also provide insights into the Iovance platform approach for TIL and anti-PD-1 therapy combinations in additional solid tumors."