Bristol-Myers Squibb Company has reported negative results from the Phase III CheckMate -331 trial of Opdivo.
The trial examined Opdivo (nivolumab) against chemotherapy, topotecan or amrubicin, to treat patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy.
It failed to meet its primary endpoint of overall survival (OS) with Opdivo versus chemotherapy.
However, safety profile of Opdivo was reported to be consistent with that found in previous monotherapy studies involving patients with SCLC.
During the open-label, randomised trial, patients were distributed into two treatment arms. The experimental arm assessed Opdivo, while the active comparator arm evaluated topotecan or amrubicin based on their approval.
The trial’s secondary endpoints comprised progression-free survival and objective response rate.
Bristol-Myers Squibb thoracic cancers development lead Sabine Maier said: “Small cell lung cancer is a highly aggressive disease in which significant unmet need remains.
“We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer.”
According to the World Health Organization, lung cancer is the major cause of cancer deaths globally, resulting in around 1.8 million deaths annually.
SCLC is one of two main types of lung cancer. It is an aggressive disease and its symptoms are often not detected until the cancer is at an advanced stage.
The disease is estimated to account for nearly 10% to 15% of all lung cancers.
Bristol-Myers Squibb’s Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is capable of restoring the body's anti-tumour immune response.
The drug can be used as a treatment option for various cancers.