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

Commentary
Video

The professor from Cedars Sinai discussed data he is anticipating from further investigations into 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.
Related Videos
Nathan Yozwiak, PhD, on Researching AAV Gene Therapy Delivery to the Brain
Salvador Rico, MD, PhD, on Informing Clinical Trials With Natural History Studies in Dravet
Zheng-Yi Chen, DPhil, on International Collaboration on Clinical Trials
Janice Chen, PhD, the cofounder and chief technology officer of Mammoth Biosciences
Sekar Kethiresan, MD, on Following up VERVE-101 With Next-Generation Editing Therapies
Maria Escolar, MD, the chief medical officer of Forge Biologics
Leigh Ramos-Platt, MD, on Allowing Access and Ensuring Preparation for Gene Therapies
John Murphy, PhD, the chief scientific officer of Arbor Biotechnologies
Erika Fullwood Augustine, MD, MS, the associate chief science officer of the Kennedy Krieger Institute
Maria Escolar, MD, the chief medical officer of Forge Biologics
© 2024 MJH Life Sciences

All rights reserved.