Omid Hamid, MD, on First of its Kind Approval of Lifileucel TIL Therapy for Advanced Melanoma

“It's important to understand that there was clearly no second line therapy available for advanced melanoma and this does fill a role. What we have seen here is a therapy in heavily pretreated patients that has shown a significant response, about a 31% response, and about 40% of those are ongoing after a year and some for many years.What this proves is what we've known for an extended period of time, that reintroducing T cells and getting them directly into tumor leads to durable clinical benefit. What it also lends us to do is to build upon that backbone.Now that we have an approval, it gives us the power to move forward as a whole field.That’s been something we've been interested in fora very long time.”

In February 2024, the FDA granted accelerated approval to Iovance Biotherapeutics’ lifileucel, under the name Amtagvi, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, or treated with a BRAF inhibitor with or without a MEK inhibitor in the instance that the patient is if BRAF V600 positive. The approval marked the first cellular therapy to receive this indication. Lifileucel is a tumor-derived autologous T cell immunotherapy and will cost $515,000 yearly.

CGTLive® spoke with Omid Hamid, MD, professor and director, Melanoma Program, Cedars-Sinai and chief, Translational Research and Immunotherapy, The Angeles Clinic and Research Institute, about the landmark approval. Hamid served as a principal investigator on the pivotal trials (NCT02360579; NCT05727904) that supported the accelerated approval. Hamid discussed how the novel mode of therapy stands to revolutionize the treatment and investigational landscape for melanoma and other cancers. He further detailed the unique mechanism of tumor-infiltrating lymphocyte therapies.

REFERENCE

FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma. News release. FDA. February 16, 2024. Accessed February 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma