Bristol-Myers Squibb Company announced that CheckMate 026, a trial investigating the use of Opdivo or nivolumab as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer whose tumors expressed PD-L1 at equal to or less than 5%.
Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb, commented quote Opdivo 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 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 pluschemotherapy in PD-L1 negative patients unquote.
CheckMate -026 is a Phase 3, open-label, randomized study of nivolumab as monotherapy versus investigators choice chemotherapy in patients with advanced non-small cell lung cancer. 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 Opdivo 3 mg/kg intravenously every two weeks or investigators choice chemotherapy in squamous patients (gemcitabine with cisplatin/gemcitabine with carboplatin/paclitaxel with carboplatin) and non-squamous patients (pemetrexed 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 greater than or equal to 5% PD-L1 tumor expression.