BMS Announces Fails Phase 3 Trial

Bristol-Myers Squibb Company has announced that CheckMate -026, a trial investigating the use of Opdivo (nivolumab) 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 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, M.D., chief executive officer, Bristol-Myers Squibb, commented, “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.”

About CheckMate -026

CheckMate -026 is a Phase 3, open-label, randomized study of Opdivo as monotherapy versus investigator’s choice chemotherapy in patients with advanced non-small cell lung cancer (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 Opdivo 3 mg/kg intravenously every two weeks or investigator’s 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 ≥ 5% PD-L1 tumor expression.