Opdivo was not proven as an effective monotherapy in patients with non-small cell lung cancer.
Bristol-Myers Squibb recently announced that its drug Opdivo (nivolumab) did not reach its primary endpoint in the clinical trial CheckMate-026 as a monotherapy for advanced non-small cell lung cancer (NSCLC).
The phase 3 clinical trial enrolled 541 treatment-naïve patients whose tumors tested positive for PD-L1 expression. Patients included in the trial had tumors that expressed PD-L1 at ≥ 5%.
Patients either received Opdivo every 2 weeks or a chemotherapy in squamous patients, according to a press release. The primary endpoint was progression-free survival, which was not met.
Opdivo previously received FDA-approval for the treatment of metastatic melanoma, advanced renal cell carcinoma, classical Hodgkin lymphoma, and for certain patients with metastatic NSCLC with progression on or after platinum-base chemotherapy.
“Opdivo has become a foundational treatment that is transforming cancer care across multiple tumor types,” said Giovanni Caforio, MD, chief executive officer, Bristol-Myers Squibb. “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.”