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Bristol-Myers Squibb Company (NYSE:BMY) today announced long-term follow-up results (median follow up of 20.3 months) from the lung cancer cohort (n=129) of the expanded Phase 1 dose-ranging study (003) of nivolumab, an investigational PD-1 immune checkpoint inhibitor. Results showed sustained activity in heavily pre-treated patients with non-small-cell lung cancer (NSCLC) as defined by one- and two-year survival rates of 42% and 24%, respectively, across dose cohorts. These data, which are based on Kaplan-Meier estimates, will be presented on October 29 at the World Conference on Lung Cancer (Abstract # MO18.03).
“Our goal with immuno-oncology is to change survival expectations and the way patients live with cancer,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunology, Bristol-Myers Squibb. “These are encouraging Phase 1 results from the expanded cohort of patients with lung cancer, the leading cause of cancer deaths globally, and we are seeking to confirm these early data in ongoing Phase 3 trials.”
“Lung cancer is very difficult to treat and there continues to be a high unmet medical need for these patients, especially those who have received multiple treatments,” added Dr. David Spigel, program director of Lung Cancer at Sarah Cannon Research Institute and Study 003 investigator. “With nivolumab, we are investigating an approach to treating lung cancer that is designed to work with the body’s own immune system, and these are encouraging Phase 1 results that support further investigation in larger scale trials.”
Study 003 Results
This analysis is reflective of 129 NSCLC patients, including both squamous and non-squamous histologies. All patients had at least one therapy prior to nivolumab and 54% received three or more therapies prior to nivolumab. Across dose cohorts, the one- and two-year survival rates were 42% and 24%, respectively, based on Kaplan-Meier estimates, and median overall survival (mOS) was 9.9 months. In all treated patients, the objective response rate (ORR) was 17%, as measured by RECIST criteria. An analysis of the 129 NSCLC patients in this study by select patient characteristics demonstrated that nivolumab had activity across a broad range of patients, including those with mutations in key signaling pathways in lung cancer such as EGFR and KRAS.