Opdivo’s Phase III failure paves the way for Keytruda to be the first PD-1/PD-L1 inhibitor for first-line NSCLC.
By Dustin Phan, Analyst
13 August 2016
I am an analyst at Datamonitor Healthcare based in the San Diego – California office, where I am currently a member of...
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On 5 August 2016, Bristol-Myers Squibb announced that its blockbuster immunotherapy Opdivo (nivolumab) had failed to meet the primary endpoint of its pivotal Phase III trial in treatment-naïve non-small cell lung cancer (NSCLC) patients. While the company will continue to pursue this treatment setting by testing Opdivo in combination with other therapies, these disappointing results delay Opdivo’s expansion into the first-line setting, positioning Keytruda (pembrolizumab; Merck & Co) to become the first programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitor approved for treatment-naïve NSCLC.
Topline data from the pivotal Phase III CheckMate 026 trial revealed that Opdivo failed to meet its primary endpoint of progression-free survival (PFS) in previously untreated NSCLC. Patients in this study were randomized to either Opdivo monotherapy or a physician’s choice platinum-based chemotherapy regimen. In addition, all patients were screened for PD-L1-positive expression at ≥5% (ClinicalTrials.gov identifier: NCT02041533). Despite selecting patients with PD-L1-positive expression, the drug was unable to demonstrate statistically significant improvements in efficacy over conventional chemotherapy regimens.
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