The [ immunotherapy combination ] of ipilimumab and nivolumab may result in a higher levels of toxicities in patients with unresectable pleural mesothelioma than was reported in the CheckMate 743 trial, according to a recent study published by McNamee et al in the Journal of Thoracic Oncology.
Background: Australia has one of the highest rates of asbestos-associated diseases such as mesothelioma—which remains an area of unmet need, with a 5-year overall survival rate of 10%.
Based on the results of the CheckMate 743 trial and supportive data from the later-line single-arm MAPS2 trial, first-line [ immunotherapy combination of ] ipilimumab plus nivolumab may be the standard of care for the treatment of this patient population.
Study Methods and Results: In [ Brief Report: Real-World Toxicity and Survival of Combination Immunotherapy in Pleural Mesothelioma—RIOMeso ], investigators retrospectively collected demographic and clinicopathologic data from 119 patients, with a median age of 72, who had pleural mesothelioma and received treatment with ipilimumab plus nivolumab in both first-line and subsequent settings. A total of 83% of the patients were male, 92% had Eastern Cooperative Oncology Group (ECOG) scores ≤ 1, 50% were current or former smokers, and 78% had known asbestos exposure. Additionally, 50%, 19%, and 14% of the patients had epithelioid, sarcomatoid, and biphasic mesothelioma, respectively.
The investigators further assessed the patients’ survival and toxicity outcomes using the Kaplan-Meier method and the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, respectively.
The investigators reported the median overall survival among all patients was 14.5 months. First-line use of [ immunotherapy combination of ] ipilimumab and nivolumab was observed in 75% of patients. Those treated with the drug combination in a second- or later-line setting had a median overall survival of 15.4 months.
The investigators reported no statistically significant differences in median overall survival between patients with epithelioid and nonepithelioid histology. Approximately 24% of the patients experienced CTCAE grade ≥ 3 adverse events—with colitis being the most frequent.
Conclusions: According to the investigators, their new findings may mark a significant milestone as one of the first detailed reports of real-world survival and toxicity outcomes in patients undergoing [ immunotherapy combination of ] ipilimumab and nivolumab treatment for pleural mesothelioma. They suggested that in real-world practice, the [ immunotherapy combination ] may have poorer survival outcomes and cause more toxicities compared with clinical trial data—underscoring the significance of understanding the treatment landscape beyond controlled trial settings.
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