Lifileucel's Phase 3 TILVANCE-301 Trial Kicks Off in Patients With Melanoma


The TIL therapy has a PDUFA date of November 25, 2023.

Iovance Biotherapeutics has randomized the first patient in its phase 3 TILVANCE-301 trial (NCT05727904) assessing the tumor infiltrating lymphocyte (TIL) therapy lifileucel in combination with pembrolizumab in patients with untreated, unresectable or metastatic melanoma.1

“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,” Friedrich Graf Finckenstein, MD, chief medical officer, Iovance, said in a statement.1 “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.”

The global, multicenter, registrational trial has a ways to go, with a target enrollment of 670 patients to be randomized to the lifileucel/pembrolizumab arm (experimental) or the pembrolizumab arm (control). The trial is actively enrolling adult participants with unresectable or metastatic melanoma who have not received prior therapy for advanced melanoma. Participants in the control arm may be treated with lifileucel in an optional crossover period after experiencing disease progression.

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Iovance’s biologics license application (BLA) for lifileucel was accepted for priority review in this indication in May 2023 and a PDUFA action date was set for November 25, 2023.2 Iovance reported that no advisory committee meeting was requested and no potential issues had been identified following preliminary review of the BLA at that time.

“The BLA acceptance is a significant milestone in our mission to deliver lifileucel as the first individualized, 1-time cell therapy for a solid tumor,” Frederick Vogt, PhD, JD, the interim president and CEO of Iovance, said in a statement at that time.2 “The FDA’s commitment to a 6-month priority review validates the unmet need and urgency for new treatment options for patients with advanced melanoma who have progressed on or after standard of care therapies. I am grateful for the patients and physicians who took part in all our clinical trials, as well as the Iovance team for their outstanding work on our first BLA filing. We look forward to continuing our collaboration with the FDA during the BLA review cycle, while continuing to execute our precommercialization activities and advancing our robust TIL pipeline.”

1. Iovance Biotherapeutics Announces First Patient Randomized in Phase 3 TILVANCE-301 Trial in Frontline Advanced Melanoma. News release. Iovance Biotherapeutics. June 15, 2023.
2. Iovance Biotherapeutics announces U.S. Food and drug administration acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma. News release. Iovance Biotherapeutics, Inc. May 26, 2023. Accessed May 30, 2023.
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