Lifileucel combined with pembrolizumab is used for the treatment of advanced melanoma. Credit: Evgeniy Kalinovskiy / Shutterstock.

Iovance Biotherapeutics has randomised the first patient in a Phase III clinical trial evaluating Iovance TIL therapy lifileucel combined with pembrolizumab against pembrolizumab monotherapy in patients with frontline advanced (unresectable or metastatic) melanoma.

The registrational, global, multicentre TILVANCE-301 study intends to randomise up to 670 patients to evaluate the efficacy and safety of the experimental arm including lifileucel along with pembrolizumab against the control arm of pembrolizumab monotherapy.

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Adult participants who have not received prior therapy for advanced melanoma have been enrolled in the study.

The control arm’s participants whose disease has progressed may be treated with lifileucel monotherapy in an optional crossover period.

Iovance Biotherapeutics chief medical officer Friedrich Graf Finckenstein said: “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.

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“This trial may also provide important insights into the Iovance platform approach for TIL and anti-PD-1 therapy combinations in additional solid tumours.”

Objective response rate (ORR) of 67% and durability of response was observed in advanced melanoma patients treated with lifileucel combined with pembrolizumab in Cohort IA of the IOV-COM-202 trial conducted last April.

Iovance has received priority review for lifileucel in post-anti-PD-1 melanoma from the US Food and Drug Administration (FDA).

The target action date for a decision under the Prescription Drug User Fee Act (PDUFA) has been declared as 25 November.