Real-world outcomes with ipilimumab and nivolumab in advanced melanoma: a multicentre retrospective study

Purpose: To assess efficacy and toxicity of combination immunotherapy with ipili-mumab plus nivolumab in routine practice in a retrospective multicentre cohort of patients with advanced melanoma.Patients and methods: This retrospective analysis included patients with advanced melanoma treated with ipilimumab and nivolumab between October 2015 and January 2020 at six centres in Australia, Europe and the United States of America. We describe efficacy outcomes (overall survival [OS], progression-free survival [PFS] and objective response rate [ORR]) in treatment-nai spacing diaeresis ve and pre-treated patients, with and without brain metastases, plus treatment-related adverse events (trAEs) in all patients treated.Results: A total of 697 patients were identified; 472 were treatment-nai spacing diaeresis ve of which 138 (29.2%) had brain metastases, and 225 were previously treated of which 102 (45.3%) had brain metas-tases. At baseline, 32.3% had stage M1c and 34.4% stage M1d disease. Lactate dehydrogenase was high in 280 patients (40.2%). With a median follow-up of 25.9 months, median OS in the 334 treatment-nai spacing diaeresis ve patients without brain metastases was 53.7 months (95% confidence inter-val [CI] 40.8-NR) and 38.7 months (95% CI 18.6-NR) for the 138 treatment-nai spacing diaeresis ve patients with brain metastases. For the entire cohort the ORR was 48%, for treatment-nai spacing diaeresis ve patients without brain metastases ORR was 56.6% with a median PFS of was 13.7 months (95% CI 9.6-26.5). Median PFS was 7.9 months (95% CI 5.8-10.4) and OS 38 months (95% CI 31-NR) for the entire cohort. Grade 3-4 trAE were reported in 44% of patients, and 4 (0. 7%) treatment-related deaths (1 pneumonitis, 2 myocarditis and 1 colitis) were recorded.Conclusion: The outcome and toxicity of combination immunotherapy with ipilimumab and nivolumab in a real-world patient population are similar to those reported in pivotal trials. 2022 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Automated summary

This retrospective study assessed the efficacy and toxicity of combination immunotherapy with ipilimumab and nivolumab in patients with advanced melanoma. The results demonstrated that this treatment regimen achieved similar treatment outcomes and adverse events in real-world patient population as reported in pivotal trials.