[ An Opdivo plus Yervoy combination ] significantly improved overall survival (OS) versus chemotherapy in the first-line treatment of patients with unresectable malignant pleural mesothelioma, according to findings from a prespecified analysis of the phase 3 CheckMate-743 trial (NCT02899299) that were presented during the 2020 International Association for the Study of Lung Cancer’s World Conference on Lung Cancer Virtual Presidential Symposium.
Results showed that the median OS was 18.1 months (95% CI, 16.8-21.4) in those who received the [ Opdivo plus Yervoy combination ] (n = 303) versus 14.1 months (95% CI, 12.4-16.2) in those who received chemotherapy (n = 302; hazard ratio [HR], 0.74; 95% CI, 0.60-0.91; P = .0020). Moreover, the OS rates at 12 months were 68% versus 58% in the investigational and control arms, respectively; at 24 months, the OS rates were 41% versus 27%, respectively.
“This is the first positive randomized trial of dual immunotherapy in the first-line treatment of patients with malignant pleural mesothelioma,” said Paul Baas, MD, PhD, chief of the Department of Thoracic Oncology at the Netherlands Cancer Institute in Amsterdam, during a presentation. “Therefore, [ the Opdivo plus Yervoy combination ] should be considered as the new standard of care.”
The randomized, open-label phase 3 trial enrolled a total of 605 patients with unresectable pleural mesothelioma who had received no previous systemic therapy and had an ECOG performance status of 0 to 1. These patients were stratified based on histology, either epithelial or non-epithelial disease, and gender.
Participants were randomized 1:1 to either nivolumab at 3 mg/kg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks for up to 2 years (n = 303) or cisplatin or carboplatin plus pemetrexed every 3 weeks (n = 302). Patients received treatment until progressive disease, unacceptable toxicities, or for up to 2 years for those in the immunotherapy.
The primary end point of the trial was OS, and the key secondary end points included objective response rate (ORR), disease control rate, and progression-free survival (PFS) per blinded independent central review (BICR) and PD-L1 expression as a predictive biomarker.
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