Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study.

This study presents a 5-year follow-up of the C-144-01 trial evaluating lifileucel, a one-time autologous tumor-infiltrating lymphocyte therapy, in patients with advanced melanoma resistant to immune checkpoint or BRAF/MEK inhibitors.

The results include:

• Objective response rate: 31.4%, including 5.9% complete responses and 25.5% partial responses
• Tumor burden reduction: Experienced by 79.3% of patients
• Deepened responses: Observed over time in 16 patients
• Ongoing responses at 5 years: Maintained by 31.3% of responders
• Median duration of response: 36.5 months
• Median overall survival: 13.9 months, with a 5-year survival rate of 19.7%

Responders generally had lower tumor burden and fewer liver or brain metastases.

Adverse events were consistent with expected toxicities from lymphodepletion and interleukin-2, mostly resolving within 30 days.

Overall, lifileucel demonstrated durable efficacy and manageable safety in this difficult-to-treat population.