Advancing Melanoma Treatment: Hamid on Lifileucel's Role
In this episode of Targeted Talks, Omid Hamid, MD, discusses data supporting the use of lifileucel for the treatment of advanced melanoma.
In this episode of Targeted Talks, Omid Hamid, MD, chief of translational research and immunotherapy and director of melanoma therapeutics at The Angeles Clinic and Research Institute in Los Angeles, California, delves into the mechanism of action, supporting data, and approval of lifileucel (LN-44; Amtagvi).
Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy used for the treatment of patients with advanced melanoma who progressed on at least 1 systemic therapy, including a PD-1 inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor.1
“The way it works is we harvest a tumor from a patient, and then we obtain those T cells that are there in the tumor. We think that the majority of those T cells are tumor-directed, and they recognize multiple tumor neoantigens, so we take them out," Hamid explains.
The FDA granted an accelerated approval to lifileucel in February 2024 for the treatment of patients with advanced melanoma who have progressed after receiving an anti-PD-1 antibody and, if BRAF V600-mutation positive, a BRAF inhibitor with or without a MEK inhibitor.2 The regulatory decision was supported by data from an efficacy population of 73 patients enrolled in cohort 4 of the phase 2 C-144-01 trial (NCT02360579). These patients were treated with lifileucel at the recommended dose.1
In the study, the objective response rate among these patients was 31.5%, comprising 3 (4.1%) complete responses and 20 (27.4%) partial responses. Of the patient responders, 56.5% of patients maintained their response at 6 months, 47.8% at 9 months, and 43.5% at 12 months.
"After 4 years of follow-up from the cohorts that received lifileucel...we have seen a response rate of 31.4%...the responses were not only rapid...but they were durable," says Hamid.
With the clinically meaningful antitumor activity observed with this autologous TIL cell therapy in patients with advanced melanoma, this approval marks a significant development for clinicians and patients.
REFERENCES:
1. Wermke M, Chesney J, Whitman E, et al. Long-term efficacy and patterns of response of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: a 4-year analysis of the C-144-01 study. Ann Oncol. 2023;34(suppl 2):100589. doi:10.1016/iotech/iotech100589
2. FDA approves first cellular therapy to treat patients with unresectable or metastatic melanoma. News release. FDA. February 16, 2024. Accessed July 9, 2024. http://tinyurl.com/5n7cuszk
Navigating ESR1 Mutations in HR-Positive Breast Cancer With Dr Wander
October 31st 2024In this episode of Targeted Talks, Seth Wander, MD, PhD, discusses the clinical importance of ESR1 mutations in HR-positive metastatic breast cancer and how these mutations influence treatment approaches.
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