TIL Therapy vs Ipilimumab in Advanced Melanoma
Source: The ASCO Post, December 2022
In a Dutch-Danish phase III trial reported in The New England Journal of Medicine, Rohaan et al found that tumor-infiltrating lymphocyte (TIL) therapy prolonged progression-free survival vs ipilimumab in patients with advanced melanoma.
Study Details
The open-label trial included 168 patients (intention-to-teat [ITT] population) with unresectable stage IIIC or IV melanoma at Netherlands Cancer Institute or the National Center for Cancer Immune Therapy, Copenhagen University Hospital. They were randomly assigned between September 2014 and March 2022 to receive TIL therapy (n = 84) or ipilimumab at 3 mg/kg every 3 weeks for four doses (n = 84). Patients in the TIL group underwent metastasectomy for retrieval and expansion of TILs followed by nonmyeloablative lymphodepleting chemotherapy with cyclophosphamide and fludarabine; a single infusion of at least 5 × 109 TILs was administered, followed by high-dose interleukin-2. Stage IV disease was present in 98% of patients in both groups. Among the 168 patients, 86% had disease refractory to anti–PD-1 therapy. The primary outcome measure was progression-free survival in the ITT population.
Progression-Free Survival
At data cutoff in June 2022, median follow-up was 33.0 months. Median progression-free survival was 7.2 months (95% confidence interval [CI] = 4.2–13.1 months) in the TIL group vs 3.1 months (95% CI = 3.0–4.3 months) in the ipilimumab group (hazard ratio [HR] = 0.50, 95% CI = 0.35–0.72, P < .001). Rates at 6 months were 52.7% (95% CI = 42.9%–64.7%) vs 21.4% (95% CI = 14.2%–32.2%).