Sustained Overall Survival Benefit Observed in Lung Cancer Patients Treated with Opdivo

At the landmark 2-year time point from a pair of pivotal phase 3 studies, nivolumab (Opdivo) showed an overall survival benefit compared with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who had prior treatment.

Opdivo is a PD-1 immune checkpoint inhibitor that binds to PD-1 expressed in activated T cells, blocking the binding of PD-L1 and PD-L2 and preventing the PD-1 pathway from signaling the suppression of the immune system.

The 2 studies included the landmark phase 3, open-label, randomized CheckMate-057 clinical trial that evaluated advanced non-squamous NSCLC patients who progressed during or after 1 previous platinum doublet-based chemotherapy regimen. The second phase 3, open-label, randomized clinical trial was CheckMate-017, which evaluated Opdivo in patients with advanced squamous NSCLC who progressed during or after 1 previous platinum doublet-based chemotherapy regimen.

The primary endpoint for both studies was improved overall survival (OS) at the landmark 2-year time point, while the secondary endpoints for CheckMate-057 were objective response rate (ORR), progression-free survival (PFS) and efficacy by tumor PD-L1 expression. The secondary endpoints for CheckMate-017 included PFS and response rate.

Patients were included in both studies regardless of their PD-L1 expression status.

Participants enrolled in the CheckMate-057 and CheckMate-017 clinical trials were administered 3 mg/kg of Opdivo every 2 weeks or 75 mg/m² of docetaxel every 3 weeks.

The results of CheckMate-057 demonstrated that 29% of non-squamous NSCLC patients (with prior treatment) administered Opdivo were alive at 2 years (n=81/292) versus 16% treated with docetaxel (n=45/290) (HR: 0.75 [95% CI: 0.63, 0.91]).

CheckMate-017 revealed 23% of patients treated with Opdivo were alive at 2 years (n= 29/135) versus 8% treated with docetaxel (n=11/137) (HR: 0.62 [95% CI: 0.47, 0.80]).

“Our fundamental goal for Immuno-Oncology research is to redefine the expectation of long-term, quality survival for all patients with lung cancer,” said Nick Botwood, MD, development lead, Lung and Head & Neck, Bristol-Myers Squibb. “We will seek to continue to leverage our deep scientific expertise and our unwavering commitment to patients to deliver transformative cancer care. Today, these data from CheckMate -057 and -017 expand our understanding of the potential for Opdivo to provide a meaningful, durable survival benefit to patients with previously treated metastatic NSCLC.”

Opdivo treatment-related adverse events (AEs) occurred at 71% in CheckMate-057 and 61% in CheckMate-017. The safety profile of Opdivo at 2 years was consistent with prior data from both studies.

The data will be presented at the 52^nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago and will also include additional research to explore biomarkers that could help predict outcomes with Opdivo.

“These new data from CheckMate -057 and -017 are robust randomized phase 3 data, with the longest published follow up of patients being on therapy available for a PD-1 inhibitor in lung cancer, across histologies,” said Hossein Borghaei, DO, chief of Thoracic Oncology at Fox Chase Cancer Center. “Data presented at ASCO underscore the potential of Opdivo to improve long-term outcomes for patients with this particularly challenging disease.”