Nivolumab (Opdivo) plus ipilimumab (Yervoy) 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 [ overall survival (OS) ] was 18.1 months (95% CI, 16.8-21.4) in those who received the [ nivolumab plus ipilimumab 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 nivolumab plus ipilimumab 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 [ overall survival (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.[Article continues at original source]
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