FDA Approves Amtagvi for Pretreated, Advanced Melanoma


The Food and Drug Administration approved Amtagvi, a TIL therapy, for patients with advanced melanoma whose disease progressed on or after a checkpoint inhibitor and targeted therapy.

The Food and Drug Administration (FDA) approved Amtagvi (lifileucel) for patients with advanced melanoma whose disease progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy, according to the agency.

“This is a therapy that has a wide swath of benefit for melanoma patients,” Dr. Omid Hamid, director of the Melanoma Program, Cedars-Sinai Medical Center, chief, Translational Research and Immunotherapy and director, Melanoma Therapeutics, Phase I Immuno-Oncology Program at The Angeles Clinic and Research Institute, said in an interview with CURE®.

READ MORE: TIL Therapy Is One of Many ‘Phenomenal Discoveries’ in Melanoma Treatment

The approval is based on a global trial that included patients with pretreated unresectable or metastatic melanoma. Patients were treated with a lymphodepleting regimen before Amtagvi, then at three to 24 hours after receiving Amtagvi, patients received interleukin-2.

The main goal of the trial was objective response rate (the percentage of patients whose cancer shrinks or disappears) and duration of response. The average time to response was 1.5 months, and the objective response rate among the group of 73 patients who received the recommended dosing of Amtagvi was 31.5%, with the median duration of response not yet achieved.

These findings are particularly exciting, according to Hamid, who mentioned that this is a patient population that typically has low response rates to other therapies.

“The response rate we've seen has been high for a population where the majority of patients had more than three therapies,” he said. “So, these are patients who really have a low response rate to anything else. So, when you see that [31.5%] response rate and the durability, you're very excited for our patients.”

Amtagvi is a tumor-infiltrating lymphocyte therapy — also known as a TIL therapy — that works by engineering patients’ T cells (which are part of the immune system) to find and fight cancer. The cells are extracted from the patient, and then programmed to target specific antigens found on cancer cells. After the infusion, patients receive interleukin-2 to agitate and activate the T cells.

Amtagvi came with a Boxed Warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary and kidney impairment.

The most common side effects that occurred in 20% or more of patients were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia and dyspnea.

Looking ahead, Hamid mentioned that he is excited about new and ongoing research analyzing how to improve the tolerability of TIL treatments — such as using interleukin-15 instead of interleukin-2 — as well as the potential benefit of brining this type of cellular therapy to earlier lines of treatment and other patient populations.

“It'll be something that will become a part of the journey of every patient with melanoma, the discussion about where this fits in, because I have it every single day, three to five times with patients about where it fits in what it really means and what it will take. So I have found that the major obstacle is access at this point. And that obstacle will be obviated with the approval, hopefully.”

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