Phase 3 Trial of Lifileucel/Pembrolizumab in Frontline Advanced Melanoma Begins

Source: Dermatology Times, June 2023

The phase 3 TILVANCE-301 trial (NCT05727904) evaluating the tumor infiltrating lymphocyte (TIL) therapy, lifileucel (LN-144) in combination with pembrolizumab (Keytruda) vs pembrolizumab alone has randomized its first patient with frontline advanced, unresectable, or metastatic melanoma.

“Our strategy is to offer TIL therapy across all lines of treatment for patients with advanced melanoma. Randomizing the first patient in TILVANCE-301, our first phase 3 trial at Iovance, is an important milestone. The trial offers TIL therapy as part of an earlier treatment approach for frontline advanced melanoma, while serving as a confirmatory trial to convert an accelerated approval to full approval for lifileucel in post-anti-PD-1 melanoma,” said Friedrich Graf Finckenstein, MD, chief medical officer of Iovance, in a press release.

Lifileucel is designed for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable.