Among patients treated with the combination of nivolumab and ipilimumab, 23% were alive at 3 years, compared to 15% of patients treated with chemotherapy.
Data from the CheckMate-743 trial has found durable overall survival (OS) rates among patients with first-line unresectable malignant pleural mesothelioma who received nivolumab (Opdivo; Bristol Myers Squibb) and ipilimumab (Yervoy; Bristol Myers Squibb).
According to a press release, CheckMate-743 remains the only phase 3 trial to demonstrate a survival improvement with first-line immunotherapy in this patient population, which has now been sustained more 3 years. Data will be featured during the 2021 European Society for Medical Oncology Virtual Congress.
After a minimum follow-up of 35.5 months among patients treated with the combination of nivolumab and ipilimumab, 23% were alive at 3 years, compared to 15% of patients treated with chemotherapy. Furthermore, treatment with the dual immunotherapy combination continued to demonstrate a reduction in the risk of death and improvement in median OS, which was the trial’s primary endpoint.
The safety profile for the combination remained consistent with previously reported data in first-line malignant pleural mesothelioma, with no new safety signals identified.
“For patients with malignant pleural mesothelioma, the prognosis is generally poor, with a 5-year survival rate of approximately 10%,” said Solange Peters, MD, PhD, chair of thoracic oncology at Lausanne University Hospital in Switzerland, in the press release. “In this aggressive cancer that historically has had limited treatment options, we’ve now not only seen the potential for patients to live longer with nivolumab plus ipilimumab, but that this benefit is sustained at 3 years compared to treatment with chemotherapy.”
In addition to these findings, the researchers said that at 3 years of follow-up and approximately 1 year of being off treatment per protocol, more patients who responded to the combination remained in response than those treated with chemotherapy. Duration of response was also longer with the dual immunotherapy combination, regardless of histology.
According to the press release, 28% of patients who responded to the combination remained in response at 3 years, compared to no patients in the chemotherapy arm. Those treated with the dual immunotherapy combination had a median duration of response of 11.6 month, compared to 6.7 months with chemotherapy. Finally, the objective response rate among patients treated with the combination was comparable to chemotherapy (39.6% vs 44%, respectively).
“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,” said Abderrahim Oukessou, MD, vice president and thoracic cancers development lead at Bristol Myers Squibb, in the press 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.”
The combination has already received approval for use in first-line unresectable malignant pleural mesothelioma and the combination has shown significant improvements in OS in 6 phase 3 clinical trials among 5 tumor types: malignant pleural mesothelioma, non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, and esophageal squamous cell carcinoma.
Opdivo (nivolumab) plus Yervoy (ipilimumab) demonstrates durable overall survival at 3 years compared to chemotherapy in first-line unresectable malignant pleural mesothelioma in phase 3 CheckMate-743 trial. News release. Bristol Myers Squibb; September 13, 2021. Accessed September 14, 2021. https://news.bms.com/news/details/2021/Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Demonstrates-Durable-Overall-Survival-at-Three-YearsCompared-to-Chemotherapy-in-First-Line-Unresectable-Malignant-Pleural-Mesothelioma-in-Phase-3-CheckMate--743-Trial/default.aspx