Pivotal phase III trial included approximately 600 patients not eligible for curative surgery
Nivolumab in combination with ipilimumab demonstrated statistically and clinically significant gains of overall survival (OS) in patients with previously untreated malignant pleural mesothelioma (MPM).
CheckMate 743 is an open-label, multicenter, randomized phase III trial that investigated the safety and efficacy of nivolumab and ipilimumab in comparison with chemotherapy as first-line therapy in patients with unresectable MPM (NCT02899299).
Eligible patients were over 18 years old with histologically confirmed MPM that was not eligible for curative surgery. Patients were required to have an ECOG of 0 or 1, an acceptable blood work and an available tumor sample for testing.
Exclusion criteria were:
• patients with primary mesotheliomas of the peritoneum, pericardium and testicular vaginal tunica;
• untreated central nervous system metastases;
• and a history of another malignancy in the past 3 years.
Approximately 600 patients were included in the trial. In the investigation group, patients received nivolumab 3 mg / kg every 2 weeks and ipilimumab 1 mg / kg every 6 weeks. In the control arm, the chemotherapy regimen consisted of pemetrexed and cisplatin or carboplatin.
The primary end point was OS and the secondary end points were objective response rate, disease control rate, progression-free survival and correlation of PD-L1 expression with outcomes. The pre-specified interim analysis was conducted by an independent data monitoring committee.
The trial showed no new adverse effects from the combination of immunotherapy. Other findings from the trial will be presented at an upcoming medical meeting and sent to regulatory agencies.
Disselhorst MJ, Quispel-Janssen J, Lalezari F, et a. Ipilimumab and nivolumab in the treatment of recurrent malignant pleural mesothelioma (INITIATE): results of a prospective, single-arm, phase 2 trial. Lancet. doi:10.1016/S2213-2600(18)30420-X