Iovance announces first patient randomized in Phase 3 TILVANCE-301 trial

Iovance Biotherapeutics announced that the first patient was recently randomized in TILVANCE-301, a global, multicenter, registrational Phase 3 trial comparing Iovance TIL therapy lifileucel in combination with pembrolizumab versus pembrolizumab monotherapy in frontline advanced melanoma. Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, “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. TILVANCE-301 is expected to be well underway at the time of potential accelerated approval in this initial indication. This trial may also provide important insights into the Iovance platform approach for TIL and anti-PD-1 therapy combinations in additional solid tumors.”