On June 15, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported 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 (unresectable or metastatic) melanoma (Press release, Iovance Biotherapeutics, JUN 15, 2023, View Source [SID1234632727]).
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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."
TILVANCE-301 builds on Iovance clinical data and decades of experience at the National Cancer Institute (NCI) on the use of TIL therapy in early line advanced melanoma patients. An oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2021 highlighted positive results for Iovance TIL therapy in combination with pembrolizumab in patients with advanced melanoma, cervical and head and neck cancers who were naïve to prior anti-PD-1 therapy. In April 2022, Iovance announced updated positive results demonstrating a 67% ORR and durability of response for lifileucel in combination with pembrolizumab in advanced melanoma from Cohort 1A of the IOV-COM-202 trial, which have remained consistent in nearly 20 patients treated to date.
The U.S. Food and Drug Administration (FDA) previously agreed that dual primary endpoints of objective response rate (ORR) and progression free survival (PFS) in TILVANCE-301 can support accelerated and full approvals of lifileucel in frontline advanced melanoma. The FDA also agreed that TILVANCE-301, which is expected to be well underway at the time of a potential accelerated approval of lifileucel in post-anti-PD-1 melanoma, can serve as the confirmatory trial for full approval in this initial indication. The FDA granted Priority Review for lifileucel in post-anti-PD-1 melanoma and assigned November 25, 2023, as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA).
About TILVANCE-301
TILVANCE-301 will randomize approximately 670 patients to investigate the safety and efficacy of lifileucel in combination with pembrolizumab (experimental arm) compared with pembrolizumab monotherapy (control arm). Trial sites are actively enrolling adult participants with unresectable or metastatic melanoma who have not received prior therapy for advanced disease. Participants randomized to the control arm who experience disease progression may be treated with lifileucel monotherapy in an optional crossover period. For more information, eligibility criteria, and trial locations, please visit www.clinicaltrials.gov (NCT05727904) or contact [email protected].