Nivolumab plus ipilimumab conferred a durable survival benefit compared with chemotherapy as first-line treatment for unresectable malignant pleural mesothelioma, according to randomized phase 3 trial data released by the manufacturer.
The open-label, multicenter CheckMate-743 trial included 605 patients who received six cycles of pemetrexed and cisplatin or carboplatin chemotherapy (n = 302) or 3 mg/kg nivolumab (Opdivo, Bristol Myers Squibb) every 2 weeks plus 1 mg/kg ipilimumab (Yervoy, Bristol Myers Squibb) every 6 weeks.
First-line nivolumab plus ipilimumab significantly extended OS compared with platinum-based chemotherapy for patients with unresectable malignant pleural mesothelioma.
OS served as the primary endpoint. Minimum follow-up was 35.5 months.
Results showed 23% of patients who received the immunotherapy combination remained alive at 3 years compared with 15% of those who received chemotherapy, according to a Bristol Myers Squibb press release.
The combination conferred a sustained reduction in risk for death (HR = 0.73, 95% CI, 0.61-0.87) and improvement in median OS (18.1 months vs. 14.1 months) vs. chemotherapy.
In addition, 28% of patients who responded to the combination remained in response at 3 years vs. none in the chemotherapy group, regardless of histology (median duration of response, 11.6 months vs. 6.7 months). Objective response rates appeared comparable between the groups (39.6% vs. 44%).
Researchers observed no new safety signals with the combination.
“The results from the CheckMate-743 trial have changed the way physicians treat malignant pleural mesothelioma, a disease that had no new systemic treatment options for nearly 15 years before the approval of Opdivo plus Yervoy,” Abderrahim Oukessou, MD, vice president of thoracic cancers and development lead for Bristol Myers Squibb, said in the release. “We continue to see more evidence for the sustained survival benefits of dual immunotherapy across several tumors, including durable overall survival at 4 years in non-small cell lung cancer. Now, the combination has demonstrated long-term improvements in overall survival in mesothelioma, another thoracic cancer, extending the lives of patients with a devastating disease.”
Full results of the trial will be presented later this week during European Society for Medical Oncology Congress.
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