Trial Will Evaluate Frontline Treatment With Lifileucel in Melanoma


The TILVANCE-301trial, expected to be completed in 2030, is the latest study of what has been described as one of the “phenomenal discoveries in melanoma.”

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A clinical trial kicked off and will evaluate lifileucel plus Keytruda in advanced melanoma.

The first participant has been randomized in a phase 3 trial evaluating the novel polyclonal tumor-infiltrating lymphocyte (TIL) therapy lifileucel combined with Keytruda (pembrolizumab) against Keytruda alone in the frontline treatment of patients with advanced unresectable or metastatic melanoma, according to a news release from biotechnology company Iovance Biotherapeutics.

The global TILVANCE-301 trial, according to its listing on, is currently recruiting participants, and will have an estimated enrollment of 670 patients who have received no prior therapies for metastatic disease, with an estimated study completion date of March 1, 2030.

The primarily outcomes of TILVANCE-301 are objective response rate (percentage of patients whose tumors shrink from treatment) and progression-free survival (how long patients live without the disease worsening), with secondary outcome measures including overall survival (the time from treatment until death of any cause), complete response rate (when no trace of cancer remains following treatment), duration of response, event-free survival (the time that a patient lives without complications from the disease) and side effects.

Discussing lifileucel with CURE® in 2022, Dr. Omid Hamid, director of clinical research at Cedars-Sinai The Angeles Clinic and Research Institute in Los Angeles, described the treatment as one of the “phenomenal discoveries in melanoma.”

Adoptive TIL therapies such as lifileucel, Hamid explained, work by utilizing harvested tumor cells.

“The way it's done is the patient is identified, an area is resected — about 1.5 centimeters — and that's sent out. … Those tumor-infiltrating T cells are taken out, cleaned and grown to billions of cells,” he said. “Then they're activated and sent back. The patient is sitting somewhere — maybe it's in Los Angeles, maybe it's in Kentucky — they come in and get the lymphodepletion a week before. They could do that in the hospital or in the clinic, but ultimately, they're admitted to a monitored bed where they receive the tumor-infiltrating lymphocytes.

“Within six to 24 hours later, we begin an every six- to eight-hour infusion of interleukin 2 (or IL-2) to stimulate the immune system and the T cells. And they're monitored until their counts recover, until (side effects) are gone and then they're sent home. And that's a phenomenal option for patients.”

Iovance announced on May 26 that the Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for the use of lifileucel in treating patients with advanced melanoma, and had granted the therapy Priority Review status, assigning Nov. 25, 2023, as the target action date for a decision.

The FDA, according to Iovance, “is not currently planning to hold an advisory committee meeting to discuss this application and, after a preliminary review, has not at this time identified any potential review issues.”

“Our strategy is to offer TIL therapy across all lines of treatment for patients with advanced melanoma,” Dr. Friedrich Graf Finckenstein, chief medical officer of Iovance, said in the news release. “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.”

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