A dual immunotherapy regimen of Opdivo (nivolumab) and Yervoy (ipilimumab) can prolong the survival of patients with untreated, inoperable malignant pleural mesothelioma (MPM), according to data from a Phase 3 clinical trial.
Findings from this study about MPM, a severe form of cancer of the pleura (the protective lining surrounding the lungs), were presented by Bristol Myers Squibb, the therapies’ developer, at the 2020 World Conference on Lung Cancer Virtual Presidential Symposium. The event was hosted by the International Association for the Study of Lung Cancer on Aug. 8.
Opdivo and Yervoy belong to a class of medications known as immune checkpoint inhibitors and work by blocking the activity of proteins — PD-1 in the case of Opdivo and CTLA-4 in the case of Yervoy — found on the surface of immune T-cells. These proteins often are hijacked by cancer cells to avoid being targeted and destroyed by the immune system.
By blocking the activity of these proteins, the medications are expected to increase T-cells numbers and their effectiveness at recognizing and eliminating malignant cancer cells.
When used together, their effects are thought to be amplified, as Yervoy can promote the activation and formation of new T-cells, including memory-T-cells, while Opdivo can help existing T-cells to find the tumor.
The CheckMate -743 Phase 3 trial (NCT02899299) was designed to investigate the safety and effectiveness of this combination therapy, versus standard treatment with one of two platinum-based chemotherapy regimens (cisplatin or carboplatin plus pemetrexed), in 605 untreated patients with inoperable MPM.
Those assigned to the combination therapy received both medications for up to two years, or until showing signs of disease progression or unacceptable toxicity. Patients assigned to chemo received treatment for up to six cycles, or until disease progression or unacceptable toxicity.
The main goal of the study is to determine if the Opdivo-Yervoy combination is superior to chemo at prolonging patients’ survival. Additional study goals include the percentage of patients responding to treatment and those showing no signs of disease worsening. The time patients live without disease progression also will be assessed.
Data from CheckMate -743 now presented by the company showed that at a minimum follow-up of 22 months, the combination therapy prolonged the time patients lived from a median of 14.1 months with standard chemo to 18.1 months, lowering the risk of death by 26%.
Trial data also showed that two years after starting treatment, nearly half (41%) of the patients treated with Opdivo and Yervoy were still alive, compared with 27% of those receiving standard treatment.
Importantly, the survival benefits of the combination therapy were seen in patients with different mesothelioma subtypes, including those with the non-epithelioid form that is normally associated with a poorer prognosis. In this subset of patients, the immunotherapy combination prolonged survival from a median of 8.8 to 18.1 months.
“Now, for the first time, we have evidence that a dual immunotherapy combination showed a superior, sustained overall survival benefit compared to chemotherapy in the first-line treatment of all types of malignant pleural mesothelioma,” Paul Baas, MD, PhD, from the department of Thoracic Oncology at the Netherlands Cancer Institute and University of Leiden, said in a press release.
The CheckMate -743 data support the potential for nivolumab plus ipilimumab to become a new standard of care,” Baas said.
The safety profile of the combination was found to be consistent with that reported in previous studies. No new safety signals were observed.
“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,” said Sabine Maier, vice president of Oncology Clinical Development at Bristol Myers Squibb.
“We look forward to discussions with global health authorities over the coming months about the positive results from CheckMate -743,” Maier added.
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