CHECKMATE-743
Trial question
What is the role of nivolumab plus ipilimumab in patients with previously untreated unresectable malignant pleural mesothelioma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 605
605 patients (138 female, 467 male).
Inclusion criteria: adult patients with previously untreated unresectable malignant pleural mesothelioma.
Key exclusion criteria: brain metastases; autoimmune disease; previous treatment with drugs targeting T-cell costimulation or checkpoint pathways.
Interventions
N=303 nivolumab plus ipilimumab (nivolumab 3 mg/kg IV once every 2 weeks plus ipilimumab 1 mg/kg IV once every 6 weeks for up to 2 years).
N=302 platinum plus pemetrexed chemotherapy (pemetrexed 500 mg/m² IV plus cisplatin 75 mg/m² IV or carboplatin once every 3 weeks for up to 6 cycles).
Primary outcome
Median overall survival
18.1 months
14.1 months
18.1 months
13.6 months
9.1 months
4.5 months
0.0 months
Nivolumab plus
ipilimumab
Platinum plus pemetrexed
chemotherapy
Significant
increase ▲
Significant increase in median overall survival (18.1 months vs. 14.1 months; HR 1.33, 95% CI 1.1 to 1.61).
Secondary outcomes
No significant difference in median progression-free survival (6.8 months vs. 7.2 months; HR 1, 95% CI 0.82 to 1.21).
Safety outcomes
No significant difference in grade 3-4 treatment-related adverse events.
Conclusion
In adult patients with previously untreated unresectable malignant pleural mesothelioma, nivolumab plus ipilimumab was superior to platinum plus pemetrexed chemotherapy with respect to median overall survival.
Reference
Paul Baas, Arnaud Scherpereel, Anna K Nowak et al. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386.
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