This therapy is based on infusion of in vitro expanded autologous TILs preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2. It is a personalized treatment strategy, that include resection of tumor from an individual patient, followed by in vitro isolation, activation and expansion of the TILs from the resected tumor. After 3-6 weeks of culture, TILs are re-infused back into the same patient intravenously. Multiple ongoing phase I and II studies are evaluating TIL treatment in diverse solid tumor types. M14TIL is the first phase 3 trial to demonstrate a benefit for patients.
The Netherlands Cancer Institute and CCIT-DK will present the primary results of the study at an upcoming medical meeting. M14TIL trial findings will be discussed with EU regulatory authorities in 2022. The NKI and CCIT-DK will seek registration of TIL treatment in The Netherlands and Denmark.
The NKI and CCIT thank the patients, families and healthcare personnel who were involved in the M14TIL trial. The study was supported financially by The Dutch Cancer Society, the Netherlands Organization for Health Research and Development, The Dutch Ministry of Health, Welfare and Sport, Stichting Avento, Copenhagen University Hospital, Herlev, The Danish Cancer Society, The Capital Region of Denmark, Aase and Ejnar Danielsens Foundation. No commercial entities were involved in this study.
M14TIL (clinicaltrials.gov identifier NCT 02278887) is an investigator-sponsored, randomized, controlled phase 3 study evaluating TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 compared to ipilimumab in 168 patients with unresectable or metastatic melanoma. The primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints are PFS at 6 months according to RECIST 1.1, PFS according to immune-related response criteria (irRC), overall response rate, complete response rate, overall survival, safety and health technology assessment. Follow up for the secondary endpoints is ongoing.
Melanoma is an aggressive form cancer, where a certain type of pigment-producing cell that is primarily located in the skin grows uncontrolled. Melanoma is curable in most cases when treated at an early stage, when the disease is located only in the skin. However, when the disease spreads beyond the skin (metastatic melanoma), it is characterized by a high level of lethality despite best current care. Current medical treatments are effective only in a proportion of patients. The incidence of melanoma is rising steadily worldwide.
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