Iovance Announces Phase 3 Study Plans for Lifileucel, Pembrolizumab in Metastatic Melanoma

The FDA previously granted Fast Track Designation for the combination of lifileucel and pembrolizumab in metastatic melanoma.

Based on positive feedback from the FDA, Iovance Biotherapeutics has announced plans to open a phase 3 study of lifileucel in combination with pembrolizumab for the treatment of immune checkpoint inhibitor (ICI) naïve frontline metastatic melanoma. The trial is planned to begin in late 2022, according to a press release.

Updated data from the combination cohort of lifileucel and pembrolizumab in the IOV-COM-202 study demonstrated an overall response rate of 67%. Furthermore, 8 out of 12 patients had a confirmed objective response per RECIST 1.1, including 3 complete responses and 5 partial responses. Six of the 8 responders had an ongoing response at the time of the last data cutoff, and 5 responders had a duration of response of more than 1 year.

Based on the unmet medical need and potential advantages for the combination of lifileucel and pembrolizumab over available care, the FDA previously granted Fast Track Designation for the combination. Iovance plans to request a pre-Biologics License Application (BLA) meeting with the FDA in July 2022 and to complete its BLA submission by August.

In April, the FDA provided positive feedback to Iovance regarding the company’s proposed matrix of potency assays for its upcoming BLA for lifileucel in metastatic melanoma. The company also received positive feedback on both its potency assay matrix and its proprietary cell co-culture assay included in the potency assay matrix.

“The favorable feedback received from the FDA on our potency assays and assay matrix brings Iovance a step closer to our submission of a BLA for lifileucel in metastatic melanoma,” said Frederick Vogt, PhD, JD, interim president and CEO of Iovance, in the press release. “We look forward to bringing lifileucel to the market quickly to offer melanoma patients a new option following anti-PD-1 therapy.”


Iovance Biotherapeutics Announces Regulatory and Clinical Updates for Lifileucel in Melanoma. News release. Iovance Biotherapeutics; April 5, 2022. Accessed April 13, 2022.

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