💊FDA & DRUG TODAY
Opdivo (nivolumab), First PD-1 Inhibitor to Demonstrate Superior Survival Benefit Compared with Chemotherapy in a Predominantly Chinese Population with Previously Treated Non-Small Cell Lung Cancer (NSCLC)
(PRINCETON, NJ, APRIL 13, 2018) – Bristol-Myers Squibb Company (NYSE: BMY) announced
results from the pivotal, randomized Phase 3 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).News Release
http://www.ono.co.jp/eng/news/pdf/sm_cn180416.pdf
Opdivo Plus Low-Dose Yervoy Combination Reduces the Risk of Progression or Death by 42% Versus Chemotherapy in First-Line Lung Cancer Patients with High Tumor Mutational Burden (TMB)
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced initial results from the pivotal Phase 3 study, CheckMate -227, evaluating the Opdivo(nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab, 1 mg/kg) combination in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). In the study, the combination demonstrated a superior benefit for the co-primary endpoint of progression-free survival (PFS) versus chemotherapy (HR 0.58; 97.5% CI: 0.41 to 0.81; p=0.0002).
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