Bristol-Myers Squibb has reported that the Phase III CheckMate -026 trial of Opdivo (nivolumab) has failed to meet the primary endpoint of progression-free survival in patients with previously untreated, advanced non-small-cell lung cancer (NSCLC).
Opdivo is an PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1, which is used by the cancer cells to take refuge from the immune system and block the tumour from being exposed to it.
It prevents the binding of PD-L1 and PD-L2, blocking the PD-1 pathway's suppressive signalling on the immune system including the interference with an anti-tumour immune response.
The open-label, randomised Phase III CheckMate 026 trial was designed to measure the efficacy of Opdivo as monotherapy against a chemotherapy regimen of the investigator’s choice to treat NSCLC.
The trial involved 541 patients who had no history of prior systemic treatment for advanced disease and tested positive for PD-L1 expression of the tumours.
It was primarily focused to determine the progression-free survival resulted by the administration of Opdivo, which was not met by the study.
Bristol-Myers Squibb CEO Giovanni Caforio said: “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 programme, including the ongoing Phase III 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.”
The company will fully examine the CheckMate -026 trial data and collaborate with the investigators for future presentation of the results.