Lancet Respir Med 2021 Apr 9. Epub 2021 Apr 9.
Center for Immuno-Oncology, Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Siena, Italy; EPigenetic Immune-Oncology Consortium Airc (EPICA), Rome, Italy; Department of Medicine, Surgery, and Neuroscience, University of Siena, Siena, Italy; Fondazione Italian Network for Tumour Biotherapy (NIBIT) Onlus, Siena, Italy. Electronic address:
Background: The NIBIT-MESO-1 study demonstrated the efficacy and safety of tremelimumab combined with durvalumab in patient with unresectable mesothelioma followed up for a median of 52 months [IQR 49-53]. Here, we report 4-year survival and outcomes after retreatment, and the role of tumour mutational burden (TMB) in identifying patients who might have a better outcome in response to combined therapy.
Methods: NIBIT-MESO-1 was an open-label, non-randomised, phase 2 trial of patients with unresectable pleural or peritoneal mesothelioma who received intravenous tremelimumab (1 mg/kg bodyweight) and durvalumab (20 mg/kg bodyweight) every 4 weeks for four doses, followed by maintenance intravenous durvalumab at the same dose and schedule for nine doses. Read More