Multicenter phase 2 study of one-time autologous TIL cell therapy for recurrent and/or metastatic head and neck squamous cell carcinoma

Recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) has a high recurrence rate after first-line immunotherapy or chemoimmunotherapy. The presence of a high density of tumor-infiltrating lymphocytes (TILs) in HNSCC tumors was shown to be associated with improved clinical outcomes. A multicenter phase 2 trial in the USA evaluated one-time autologous TIL cell therapy in patients with R/M HNSCC. Most patients (98%) had stage IV disease; median prior lines of systemic therapy were two. The objective response rate to TIL cell therapy was 11% with a median duration of response 7.6 months. Additional 64% of patients had stable disease. The authors conclude that this study demonstrated the feasibility of consistently generating sufficient TIL from HNSCC tumors.