Loading
In a head-to-head trial, tumour-infiltrating lymphocyte therapy halved the risk of progression compared with ipilimumab in melanoma that had mostly already failed PD-1 blockade.
This academic phase 3 trial from the Netherlands Cancer Institute and Copenhagen randomised 168 patients with unresectable stage IIIC-IV melanoma, 86% of whom had progressed on anti-PD-1 therapy, to TIL therapy (tumour resection, ex vivo expansion, cyclophosphamide-fludarabine lymphodepletion, infusion and high-dose interleukin-2) or ipilimumab 3 mg/kg. The primary endpoint was progression-free survival. Median PFS was 7.2 versus 3.1 months (hazard ratio 0.50); objective response was 49% versus 21% and complete response 20% versus 7%. Grade 3 or higher adverse events occurred in all TIL patients, driven by chemotherapy and IL-2, and were transient. Median overall survival was 25.8 versus 18.9 months, not statistically significant. It is the first randomised evidence that a cell therapy improves outcomes in a solid tumour.
This trial supplied the randomised proof that was missing for TIL therapy and showed academic centres can run cell-therapy phase 3 trials without industry. It supports TIL as a standard option after checkpoint inhibitor failure in melanoma and underpinned reimbursement in the Netherlands. The comparator, ipilimumab, is itself only modestly effective in this setting, and overall survival did not differ significantly.
Shares Ton Schumacher, John Haanen, Lifileucel, Tumour-infiltrating lymphocytes (TILs).
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, Lifileucel, TIL therapy, Melanoma.
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, Lifileucel, TIL therapy, Melanoma.
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, Lifileucel, TIL therapy, Melanoma.
Shares John Haanen, Netherlands Cancer Institute (NKI-AvL), CTLA-4, Ipilimumab.
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, Aldesleukin (high-dose IL-2), Lifileucel, TIL therapy.
Shares Aldesleukin (high-dose IL-2), CTLA-4, Ipilimumab, Melanoma.
Shares Ton Schumacher, John Haanen, Netherlands Cancer Institute (NKI-AvL), Melanoma.