Omid Hamid, MD, on Post-Approval Research With Lifileucel

“The approval of lifileucel is only the first step. Those of us who have treated advanced melanoma for a long time know the power of this therapy, that it extends to multiple solid tumors and lifileucel in clinical trials is being looked at in head and neck cancer and lung cancer. The data with cervical cancer is significant. But this type of therapy has shown durability in clinical trials in other solid tumors including colorectal cancer and breast cancer, and is being looked at in certain sarcomas.”

Iovance Biotherapeutics’ lifileucel was granted accelerated approval by the FDA in February 2024, marking the first approved cellular therapy for treating solid tumors. The therapy, marketed under the name Amtagvi, is approved 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. 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, to learn more about the approval and further investigations with lifileucel.

Hamid served as a principal investigator on the pivotal trials (NCT02360579; NCT05727904) that supported the accelerated approval. Hamid gave an overview of some other investigations into lifileucel, including bringing the therapy into earlier lines of treatment for melanoma and improving tolerability and efficacy of lifileucel by tweaking lymphodepletion regimens, dose, and usage of interleukins. He anticipates data from these studies and predicted that the approval will provide impetus for more research.

REFERENCE

FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma. News release. FDA. February 16, 2024. Accessed February 16, 2024.