US FDA Accepts Bristol-Myers Squibb’s sBLA for Opdivo (nivolumab) to Include Previously Treated Squamous NSCLC

The FINANCIAL — Bristol-Myers Squibb Company on September 7 announced longer term survival and safety data from CheckMate -017 and -063, two pivotal trials evaluating Opdivo in previously treated squamous (SQ) non-small cell lung cancer (NSCLC), showing sustained survival benefit across these studies.

In both trials, Opdivo showed an estimated 18 month overall survival (OS) rate of 27% (CheckMate -063) to 28% (CheckMate -017); survival benefit was independent of PD-L1 expression. The safety profile of Opdivo is consistent with previously-reported trials, and in CheckMate -017, is also favorable compared to docetaxel. These data will be presented today at the 16th World Conference on Lung Cancer, according to Bristol-Myers Squibb.

“Immuno-Oncology agents like Opdivo provide a novel approach to treating cancer. The improvement in survival observed in advanced squamous non-small cell lung cancer represents an important step forward for our patients,” said Suresh S. Ramalingam, M.D., director, Division of Medical Oncology, Winship Cancer Institute of Emory University. “These updated results demonstrate the ability to achieve longer term survival outcomes in this patient population. In fact, the Kaplan-Meier curve from this study suggests a prolonged survival benefit for a subset of patients.”

Previously-reported one year results from CheckMate -017 showed a significantly superior OS rate of 42% versus 24% for docetaxel. In CheckMate -063, the estimated one-year survival rate was 39%.

“Our approach to Immuno-Oncology research is intended to show meaningful improvement over the traditional standard of care on the benchmark endpoint of overall survival,” said Michael Giordano, senior vice president, head of Development, Oncology. “We have taken a comprehensive research approach in lung cancer, one focused on a commitment to providing the first major advancement in squamous non-small cell lung cancer in more than a decade – Opdivo – that offers the potential to replace chemotherapy. With the data presented today, we remain confident in our Immuno-Oncology strategy, including fulfilling our goal in showing the survival benefit for Opdivo, not only in non-small cell lung cancer, but similar to the data already observed in advanced melanoma and other tumor types.”