Five-Year Survival Observed With Opdivo (nivolumab) in PatientsWith Previously Treated Advanced Non-Small Cell Lung Cancer(NSCLC), in Phase 1 Study CA209-003
Estimated five-year overall survival rate in previously treatedadvanced NSCLC patients who received Opdivo was 16%; survival wasobserved across PD-L1 expression levels and tumor histologies
Data represent the longest survival follow-up with an anti-PD-1therapy in advanced NSCLC
MONDAY, APRIL 3, 2017 8:30 AM EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company(NYSE:BMY) today announced the first report of five-year overallsurvival (OS) data from the Phase 1 dose-ranging study CA209-003evaluating Opdivo in patients with previously treated advancednon-small cell lung cancer (NSCLC; n=129). Overall survival was anexploratory endpoint in this study. The estimated OS rate at fiveyears was 16% in heavily pre-treated NSCLC patients; survival wasobserved across PD-L1 expression levels and tumor histologies. Thesafety profile of Opdivo from this study was previously reported;no new safety signals were identified in this analysis. These datawere featured today during the official press program at theAmerican Association for Cancer Research (AACR) Annual Meeting 2017in Washington, D.C.
Scott N. Gettinger, M.D., a senior author of CA209-003 andassociate professor of medicine, Yale Cancer Center, New Haven,Conn., commented, 「Historically, five-year survival rates forpatients with advanced NSCLC have been less than 5%. With new dataemerging from the NSCLC cohort of CA209-003, we observe that theestimated five-year overall survival rate in Opdivo-treatedpatients in the study was 16%. In addition, based on investigatorassessments, the majority of these patients showed no evidence thattheir lung cancer had progressed at the time of their lastfollow-up. These findings offer important new insights into thelong-term clinical profile of Opdivo in this patientpopulation.」
These results also will be presented today at AACR from 4:05 –4:20 p.m. during the Update, Novel Indication, and NewImmuno-Oncology Clinical Trials session (Late-Breaking AbstractCT077).
Nick Botwood, M.D., development lead, Lung, Bristol-MyersSquibb, commented, 「Opdivo is a standard of care for second-lineNSCLC and has been an important treatment option for thesepatients. CA209-003 represents the longest follow-up analysis ofdata from a clinical trial testing an anti-PD-1 immunotherapy, andit is encouraging to observe that a subset of these heavilypre-treated patients experienced, at minimum, five years ofsurvival. We look forward to further evaluating our Immuno-Oncologyagents, including Opdivo-based combinations, with the goal ofimproving long-term survival for lung cancer patients.」