Multicenter phase 3 trial of tumor-infiltrating lymphocyte therapy versus ipilimumab for advanced melanoma

Immune checkpoint inhibitors and targeted therapies have improved outcomes in patients with advanced melanoma, but approximately half these patients will not have durable benefit. A phase 3 trial in The Netherlands and Denmark compared adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) versus ipilimumab as first- or second-line therapy for advanced melanoma. The median progression-free survival (primary end point) was 7.2 months in the TIL group versus 3.1 months in the ipilimumab group (HR 0.50; p<0.001), while median overall survival was 25.8 months versus 18.9 months. TRAEs of grade 3 or higher were seen in all patients in the TIL group versus 57% of patients in the ipilimumab group (quick take video summary).