Dr Olson on the Potential Benefit of Lifileucel in Relapsed/Refractory Metastatic Melanoma

Daniel Olson, MD, assistant professor, medicine, the University of Chicago Medical Center, UChicago Medicine, discusses the benefit associated with lifileucel (Amtagvi) in patients with unresectable or metastatic melanoma, highlighting patients likely to derive the most benefit from this treatment approach.

The FDA accelerated approval of lifileucel for the treatment of adult patients with previously treated unresectable or metastatic melanoma was granted in February 2024, Olson begins, saying that this regulatory decision represents a significant advancement in the field of melanoma management, offering a valuable treatment option for patients who have exhausted current standard treatments. Although lifileucel is not suitable for all patients due to potential adverse effects (AEs) and safety considerations, this therapy holds promise for younger patients with melanoma or older patients who remain in good health but lack effective standard therapies, he explains.

Research on tumor-infiltrating lymphocytes (TILs), including lifileucel, has demonstrated encouraging outcomes, underscoring the therapeutic potential of TILs and reaffirming findings dating back to the 1990s that suggest the curative capabilities of these agents, Olson expands. The commercial availability of lifileucel provides oncologists with another valuable tool to offer patients, particularly those with melanoma subtypes that exhibit resistance to standard immunotherapies, such as mucosal melanoma, he reports.

Notably, mucosal melanoma, which has had limited responsiveness to standard immunotherapy, may benefit from TIL-based therapies, according to Olson. Lifileucel is recommended for patients who have progressed on a prior PD-1 inhibitor and, if they have BRAF V600–positive disease, a BRAF inhibitor with or without a MEK inhibitor, he explains. However, oncologists may need to consider the timing of treatment initiation, especially for patients with BRAF mutations, prompting discussions on whether to administer the therapy earlier in the treatment course or after targeted treatment options have been exhausted, Olson says.

Ultimately, the decision on when to incorporate lifileucel in a patient’s melanoma treatment sequencing will be tailored to each patient's circumstances, balancing the potential benefits of the treatment with considerations about overall health and treatment history, he concludes.