Multinational phase 3 study of tumor infiltrating lymphocytes versus ipilimumab for advanced melanoma

Immune checkpoint inhibitors and targeted therapies have greatly improved the outcome of patients with advanced melanoma. However, as approximately half will not derive durable benefit, a large unmet need for additional treatment options remains. Adoptive cell therapy with tumor-infiltrating lymphocytes (TIL) is a treatment modality with promising response rates in advanced melanoma in phase 2 trials. A multinational phase 3 trial evaluated TIL versus ipilimumab for patients with advanced melanoma (86% anti-PD-1 refractory). Median PFS was 7.2 months with TIL versus 3.1 months with ipilimumab (HR 0.50; p<0.001). Median OS was 25.8 months with TIL versus 18.9 months with ipilimumab (HR 0.83; p=0.39). Grade 3 or higher TRAEs occurred in all TIL patients and 57% of ipilimumab patients. The authors conclude thet TIL may be a new treatment option for (anti-PD-1-refractory) advanced melanoma.