Iovance's BLA for Advanced Melanoma Therapeutic Delayed Until Q1 2023

Iovance_Michael Vi

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The FDA has delayed Iovance Biotherapeutics' Biologics License Application for lifileucel, a treatment for unresectable or metastatic melanoma, until Q1 of 2023.

The delay was due to the agency's request for additional data on the drug, Iovance announced Friday.

Frederick Vogt, Ph.D., J.D., Iovance’s interim president and CEO, said in a conference call that the company “expects to address it promptly."

“What the FDA is asking for is relatively straightforward. It shouldn’t be difficult to get it to the FDA in the first quarter of 2023,” Vogt said. He clarified that the FDA asked the company to "address comparability data between manufacturing sites that were involved in the studies.”

Lifileucel is a tumor-infiltrating lymphocyte (TIL) treatment for patients with unresectable or metastatic melanoma whose disease has worsened on or after previous anti-PD-1/L1 therapy and targeted BRAF/MEK inhibitor therapy where appropriate. At this time, there are no FDA-approved therapies in this setting.

Vogt also said the supplemental information the company will provide is "very, very complex and commercially sensitive," which he listed as the reason he cannot provide specific details. 

Earlier in November, the company presented data on the drug at the Society for Immunotherapy of Cancer (SITC) Annual Meeting held in Boston. 

In the study, all patients’ disease had progressed after checkpoint inhibitor and targeted BRAF/MEK therapy, where appropriate. All patients had received previous anti-PD-1 therapy, and more than 80% had received anti-CTLA-4 treatment.

The objective response rate (ORR) was 31%, and median duration of response (mDOR) had not been reached at 27.6 months follow-up in those cohorts, with 42% of responses extending beyond 18 months. Median overall survival (mOS) was 13.0 months in patients who had a response at their first evaluation six weeks after initial lifileucel infusion.

Iovance is expected to launch a Phase III trial of the drug in combination with Merck’s checkpoint inhibitor Keytruda (pembrolizumab) in frontline advanced melanoma before the end of 2022. This is designed to be a confirmatory trial for expected accelerated drug approval.

The FDA wants a confirmatory trial to be “well-underway,” although Vogt indicated the agency doesn’t define what “well-underway” means.

“But they seem very comfortable with our timelines…. It’s been very positive, and whatever they mean by 'well-underway,' we will be on top of it at the time of submission.”

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