Dr. Bunn on Missed Endpoint for Nivolumab in CheckMate-026 for NSCLC

Paul A. Bunn Jr., MD
Published: Friday, Aug 05, 2016


Paul A. Bunn Jr, MD, Distinguished Professor, Division of Medical Oncology/University of Colorado, James Dudley Chair in Lung Cancer Research, University of Colorado Denver, 2014 Giant of Cancer Care in Lung Cancer, discusses the phase III results from CheckMate-026, which explored nivolumab (Opdivo) monotherapy in treatment-naïve patients with advanced non–small cell lung cancer (NSCLC).

Earlier immunotherapy trials studied nivolumab, pembrolizumab (Keytruda), and atezolizumab (Tecentriq) in the second-line setting, Bunn explains, adding that all 3 agents were found to be favorable over chemotherapy. When these antibodies were moved into first-line studies, people with no PD-L1 expression were excluded. However, the CheckMate-026 study enrolled patients with PD-1 positivity ≥ 5%.

In CheckMate-026, results showed that nivolumab missed its primary endpoint of progression-free survival (PFS); moreover, Bunn says, PFS is not an appropriate endpoint. Additionally, the trial could end up having an improvement in overall survival. Full data will be presented at an upcoming medical meeting. CheckMate-227, Bunn says, is an ongoing frontline combination trial of nivolumab and ipilimumab (Yervoy) in the first-line setting that will likely need to be modified following these initial findings.

<<< View more from the 2016 International Lung Cancer Congress


Paul A. Bunn Jr, MD, Distinguished Professor, Division of Medical Oncology/University of Colorado, James Dudley Chair in Lung Cancer Research, University of Colorado Denver, 2014 Giant of Cancer Care in Lung Cancer, discusses the phase III results from CheckMate-026, which explored nivolumab (Opdivo) monotherapy in treatment-naïve patients with advanced non–small cell lung cancer (NSCLC).

Earlier immunotherapy trials studied nivolumab, pembrolizumab (Keytruda), and atezolizumab (Tecentriq) in the second-line setting, Bunn explains, adding that all 3 agents were found to be favorable over chemotherapy. When these antibodies were moved into first-line studies, people with no PD-L1 expression were excluded. However, the CheckMate-026 study enrolled patients with PD-1 positivity ≥ 5%.

In CheckMate-026, results showed that nivolumab missed its primary endpoint of progression-free survival (PFS); moreover, Bunn says, PFS is not an appropriate endpoint. Additionally, the trial could end up having an improvement in overall survival. Full data will be presented at an upcoming medical meeting. CheckMate-227, Bunn says, is an ongoing frontline combination trial of nivolumab and ipilimumab (Yervoy) in the first-line setting that will likely need to be modified following these initial findings.

<<< View more from the 2016 International Lung Cancer Congress


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TitleExpiration DateCME Credits
Community Practice Connections™: ALK-Positive NSCLC: Emerging Strategies to Inform Sequencing, Optimize Outcomes, and Address Unmet Clinical Needs Along the Disease ContinuumAug 29, 20181.5
Community Practice Connections™: Oncogenic Tumor Board in Advanced NSCLC: Leveraging Actionable Mutations Along the Disease Continuum to Optimize Patient OutcomesAug 30, 20182.0
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