Study of Nivolumab in NSCLC Fails to Meet Primary Endpoint

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The CheckMate-026 study failed to meet its primary endpoint of progression-free survival.
The CheckMate-026 study failed to meet its primary endpoint of progression-free survival.

The CheckMate-026 study, which is investigating the use of single-agent Opdivo (nivolumab) for patients with previously untreated advanced non-small cell lung cancer (NSCLC), whose tumors expressed PD-L1 at 5% or greater, failed to meet its primary endpoint of progression-free survival.1

Nivolumab, an immune checkpoint inhibitor, is approved by the U.S. Food and Drug Administration for the treatment of a variety of cancer types, including advanced melanoma, previously treated advanced NSCLC, advanced renal cell carcinoma, and relapsed/refractory classical Hodgkin lymphoma. Researchers evaluated nivolumab as first-line therapy in this patient population.

For this open-label study, investigators enrolled 541 patients with advanced NSCLC who had received no prior systemic therapy for advanced disease, and who were positive for PD-L1 expression.  Participants were randomly assigned to receive nivolumab monotherapy 3 mg/kg intravenously every 2 weeks or investigator's choice of chemotherapy until disease progression, unacceptable toxicity, or completion of 6 cycles.

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"While we are disappointed CheckMate -026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase 3 CheckMate -227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients,” said Giovanni Caforio, MD, chief executive officer of Bristol-Myers Squibb.              


  1. Bristol-Myers Squibb announces top-line results from CheckMate -026, a phase 3 study of Opdivo (nivolumab) in treatment-naive patients with advanced non-small cell lung cancer. Bristol-Myers Squibb Website. Updated August 5, 2016. Accessed August 8, 2016.

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