Bristol Myers Squibb (BMS) has reported positive data from the Phase III CheckMate -743 trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) in previously untreated, unresectable malignant pleural mesothelioma (MPM).
Data revealed a significant improvement in overall survival (OS).
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The combination therapy decreased the risk of death by 26%, with a median OS of 18.1 months compared to 14.1 months on platinum-based standard of care chemotherapy after a minimum follow-up of 22 months.
At two years, 41% of patients treated with the Opdivo plus Yervoy were alive compared with 27% of those who received chemotherapy.
The safety profile of the combination was observed to be consistent with previous data, without any new safety signals.
Improvements in survival were found in non-epithelioid and epithelioid MPM patients treated with the combination, while the magnitude of benefit was reported to be larger in the non-epithelioid subgroup.
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By GlobalDataMedian OS was 18.7 months in epithelioid patients and 18.1 months in non-epithelioid patients, compared to 16.5 months and 8.8 months, respectively, with chemotherapy.
Bristol Myers Squibb Oncology Clinical Development vice-president Sabine Maier said: “These data in malignant pleural mesothelioma follow on the established long-term efficacy of Opdivo plus Yervoy in patients with non-small cell lung cancer and further demonstrate the combination’s potential to change survival expectations in thoracic cancers.
“For more than 15 years, no new systemic treatment options that can extend survival have been approved for patients with malignant pleural mesothelioma.”
The company intends to discuss these results with global health authorities over the coming months.
Yervoy is designed to activate and proliferate T cells, while Opdivo helps existing T cells to identify the tumour.
The open-label, multi-centre, randomised CheckMate -743 trial compared the combination to chemotherapy in patients with previously untreated MPM.
The primary endpoint of the study was OS, while key secondary endpoints included objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
The trial also assessed exploratory endpoints, including safety, pharmacokinetics, immunogenicity, and patient reported outcomes.
In March, BMS said that the ELOQUENT-1 Phase III trial evaluating the Empliciti combination in patients with newly diagnosed, previously untreated multiple myeloma failed to meet the primary endpoint.
