Nivolumab Did Not Meet Primary Endpoint of Progression-Free Survival in NSCLC in CheckMate-026 Trial
Bristol-Myers Squibb Company announced last week that CheckMate-026, a phase III trial investigating the use of nivolumab (Opdivo) as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non–small cell lung cancer (NSCLC) whose tumors expressed programmed death ligand 1 (PD-L1) at ≥ 5%. The company will complete a full evaluation of the CheckMate-026 data and work with investigators on the future presentation of the results.
Giovanni Caforio, MD, Chief Executive Officer of Bristol-Myers Squibb, commented, “[Nivolumab] has become a foundational treatment that is transforming cancer care across multiple tumor types. 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 III CheckMate-227 study exploring the potential of the combination of [nivolumab] plus [ipilimumab] for PD-L1–positive patients, and [nivolumab] plus [ipilimumab] or [nivolumab] plus chemotherapy in PD-L1–negative patients.”
About CheckMate-026
CheckMate-026 is a phase III, open-label, randomized study of nivolumab as monotherapy vs investigator’s choice chemotherapy in patients with advanced NSCLC. Patients enrolled in the trial had received no prior systemic treatment for advanced disease and tested positive for PD-L1 expression. The trial randomized 541 patients to receive either nivolumab 3 mg/kg intravenously every 2 weeks or investigator’s choice chemotherapy in squamous patients (gemcitabine with cisplatin/gemcitabine with carboplatin/paclitaxel with carboplatin) and non–squamous patients (pemetrexed [Alimta] with cisplatin/pemetrexed with carboplatin) until disease progression, unacceptable toxicity, or completion of 6 cycles. The primary endpoint is progression-free survival, as assessed by the Independent Radiology Review Committee, in patients with ≥ 5% PD-L1 tumor expression.
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