Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) met its primary endpoint in a late-stage lung cancer trial, resulting in an early of the study.
The company said that its Phase III study evaluating Opdivo versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) was stopped early because the drug met its primary endpoint. An assessment conducted by the independent Data Monitoring Committee (DMC) concluded that Opdivo met the primary endpoint of demonstrating superior overall survival (OS), and therefore the DMC recommended that the company stop the study early and provide study participants the opportunity to continue or start treatment with Opdivo in an open-label extension.
“The results of CheckMate -057 mark the second time Opdivo has demonstrated a survival advantage in lung cancer,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Through our Opdivo clinical development program, we seek to bring the potential for long-term survival to a broad range of patients, across lines of therapy and stages of disease.”
Opdivo, a PD-1 inhibitor designed to take the brakes off the immune system to fight cancer, was approved last month by the US Food and Drug Administration (FDA) to treat a less common squamous form of NSCLC that had spread following treatment with chemotherapy. Additionally, the drug is approved for treatment of patients with metastatic melanoma, following treatment with the company’s Yervoy.
BMS said that it will complete a full evaluation of the final CheckMate -057 data and work with investigators on the future presentation and publication of the results.
Lung cancer is the leading cause of cancer-related death worldwide, with more than 1.5 million deaths resulting from the disease each year, according to the World Health Organization (WHO). NSCLC is one of the most common types of lung cancer, accounting for approximately 85 percent of cases. Survival rates vary depending on the type of the cancer and the stage when it is diagnosed. Globally, the five-year survival rate for Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the five-year survival rate is only two percent.
Source: Bristol-Myers Squibb
Last updated: 4/17/15; 11:50am EST