Study: Lifileucel Shows Sustained Benefit in Advanced Melanoma Over 5 Years
Key Takeaways
Lifileucel achieved a 31.4% response rate with a median response duration of over three years in patients with ICI-resistant advanced melanoma.
A third of responders were progression-free at 5 years, with some deepening from partial to complete response.
The researchers reported an acceptable safety profile with no
Lifileucel showed sustained benefit and safety in a 5-year follow-up analysis of the phase II C-144-01 study in patients with advanced melanoma, according to a new study in the Journal of Clinical Oncology.
Patients with unresectable or metastatic melanoma who were resistant to immune checkpoint inhibitors (ICIs) and, if BRAF V600 mutation-positive, BRAF/MEK inhibitors, were the focus of this study. All participants were given cryopreserved lifileucel ,an autologous tumorinfiltrating lymphocyte cell therapy approved in the U.S. based on the pivotal C-144-01 study.
According to the study results, participants in the Lifileucel arm had an objective response rate (ORR) of 31.4% (5.9% achieving complete response and 25.5% partial response). Almost 80% (79.3%) of patients saw tumor burden reduction. Nearly a third of responders maintained their response through the five-year mark.
Median response duration was 36.5 months, with median overall survival (OS) at 13.9 months. The 5-year OS rate was 19.7%. Responders had lower baseline tumor burden and fewer liver/brain metastases vs. the wider study population.
Adverse events were consistent with known effects of lymphodepletion and IL-2 administration, and no ew safety signals were reported.
“The 5-year analysis of the C-144-01 study showed long-term benefit and favorable survival with lifileucel, and no related long-term safety concerns," the authors wrote. "Lifileucel provides an optimal response when administered soon after treatment failure with anti–PD-1/PD-L1 or BRAF/MEK inhibitors."
Source: Medina T, et al. Journal of Clinical Oncology. 2025. doi:10.1200/JCO-25-00765