Bristol-Myers Squibb Company — Yervoy EMA EPAR variation assessment report (EMEA/H/C/002213, 2011)
Bristol-Myers Squibb Company · 2011 · EMA EPAR variation assessment report · company profile →
Report summary
This report details Bristol-Myers Squibb's Type II variation application for Yervoy (ipilimumab) and Opdivo (nivolumab) to extend their first-line indication for unresectable or advanced hepatocellular carcinoma (HCC). The application is supported by the Phase 3 CA2099DW study, which compared the combination therapy to sorafenib or lenvatinib. The study demonstrated statistically significant improvements in overall survival and objective response rate for the combination, despite a higher incidence of Grade 3-4 adverse events. The report includes detailed pharmacokinetic, immunogenicity, and exposure-response analyses for nivolumab and ipilimumab, along with the study's design and statistical analysis plan. The benefit-risk balance was deemed positive, leading to a recommendation for approval.
Key findings — cited to the page
| Grade 3-4 AEs (all causality) | 62.5 % | · p.146 |
| Grade 3-4 hepatitis | 15.4 % | · p.144 |
| Grade 3-4 AEs (nivo+ipi) | 69.3 % | · p.144 |
| Grade 3-4 AEs (all causality) | 69.3 % | · p.146 |
| Grade 3-4 AEs (drug-related) | 42.5 % | · p.146 |
| Grade 3-4 AEs (drug-related) | 41.3 % | · p.146 |
| Any grade AE (nivo+ipi) | 99.7 % | · p.144 |
| Any grade AE (SOC) | 98.5 % | · p.144 |
| Grade 3-4 AEs (SOC) | 62.5 % | · p.144 |
| OS improvement | 3 months | · p.147 |
| AEs leading to discontinuation (all causality) | 23.1 % | · p.146 |
| OESIs Pancreatitis | 0.3 % | · p.146 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →