Bristol-Myers Squibb Company — Opdualag EMA EPAR public assessment report (EMEA/H/C/005481, 2022)
Bristol-Myers Squibb Company · 2022 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report assesses Opdualag (nivolumab/relatlimab) for first-line advanced melanoma treatment. It details regulatory submissions, manufacturing, and quality aspects, including a 36-month shelf-life. Non-clinical studies show relatlimab's LAG-3 binding and synergistic anti-tumor effects with nivolumab, though immune-mediated toxicities were observed. Clinical trials (e.g., CA224047) demonstrate improved progression-free survival (PFS) with the combination, particularly in PD-L1 <1% patients, compared to nivolumab monotherapy. While efficacy is noted, the combination shows a higher incidence of Grade 3-4 adverse events, including myocarditis. The CHMP recommends marketing authorization for adults and adolescents aged 12+ with PD-L1 expression <1%, with conditions including restricted prescription and a Risk Management Plan.
Key findings — cited to the page
| Incidence of drug-related AEs (any grade) | 69.9 % | CA224047 · p.142 |
| Incidence of pruritus (any grade) | 25 % | CA224047 · p.142 |
| Incidence of adverse events (any grade) | 94 % | CA224047 · p.142 |
| Incidence of drug-related AEs (any grade) | 81.1 % | CA224047 · p.142 |
| Incidence of grade 3-4 drug-related AEs | 9.7 % | CA224047 · p.142 |
| Incidence of fatigue (any grade) | 29 % | CA224047 · p.142 |
| SAEs grade 3-4 | 19.5 % | Study CA224047 · p.144 |
| Incidence of adverse events (any grade) | 97 % | CA224047 · p.142 |
| Incidence of grade 3-4 adverse events | 40 % | CA224047 · p.142 |
| Incidence of grade 3-4 adverse events | 33 % | CA224047 · p.142 |
| Incidence of grade 3-4 drug-related AEs | 18.9 % | CA224047 · p.142 |
| Incidence of arthralgia (any grade) | 24 % | CA224047 · p.142 |
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 →