Positive results from CHECKMATE 078 study of Opdivo for NSCLC in Chinese patients.- BMS

Bristol-Myers Squibb Company announced results from the pivotal, randomized Phase III CheckMate -078 trial evaluating Opdivo (nivolumab) versus docetaxel in a predominantly Chinese population with previously treated advanced non-small cell lung cancer (NSCLC). In the study, Opdivo demonstrated a statistically significant benefit versus docetaxel on the primary endpoint of overall survival (OS; HR 0.68; 97.7% CI: 0.52 to 0.90; p=0.0006). An OS benefit was observed regardless of PD-L1 expression or tumor histology. Additionally, the two secondary endpoints of objective response rate (ORR) and median duration of response (mDOR) demonstrated durability with Opdivo compared with docetaxel (ORR: 17% vs. 4%; mDOR: not reached vs. 5.3 months, respectively). Findings will be presented on Monday, April 16 from 4:05-4:20 PM CDT during the Updates in Immuno-Oncology Trials session at the American Association for Cancer Research (AACR) Annual Meeting 2018 in Chicago (Abstract #CT114).

Prof. Yi-Long Wu, principal investigator of CheckMate -078, commented, �The prevalence of lung cancer in China continues to rise, and the disease remains a leading cause of cancer death. Results from CheckMate -078, in which approximately 90% of the patients are from China, are groundbreaking, as they show for the first time an immunotherapy, Opdivo, can significantly improve outcomes across key endpoints, including overall survival, compared with chemotherapy, representing a potential new approach for these patients.�

Additional data presented at AACR 2018 include progression-free survival with Opdivo versus docetaxel. In the study, Opdivo decreased risk of disease progression by 23% versus chemotherapy (HR 0.77; 95% CI: 0.62, 0.95; p=0.0147). In addition, subgroup analyses by tumor histology and PD-L1 expression levels showed Opdivo extended OS versus docetaxel. In patients with squamous NSCLC, the hazard ratio (HR) for OS was 0.61 (95% CI: 0.42 to 0.89), and in patients with non-squamous NSCLC, the HR was 0.76 (95% CI: 0.56 to 1.04). In patients whose tumors expressed PD-L1 <1% and 1 the hrs for os were 0.75 95 ci: 0.52 to 1.09 and 0.62 95 ci: 0.45 to 0.87 respectively.>

In November 2017, the Company announced that the China Food and Drug Administration had accepted the Biologics License Application for Opdivo for the proposed indication of previously treated NSCLC.