Bristol-Myers Squibb Company — Opdualag EMA EPAR variation assessment report (EMEA/H/C/005481, 2022)
Bristol-Myers Squibb Company · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
Bristol-Myers Squibb sought to expand Opdualag's (nivolumab/relatlimab) advanced melanoma indication to include patients with PD-L1 expression ≥ 1%. This Type II variation application was based on updated 4-year data from Study CA224047, comparing the fixed-dose combination (FDC) with nivolumab monotherapy. While the initial approval was limited to PD-L1 < 1% patients due to benefit-risk concerns, updated 4- and 5-year efficacy data showed improved overall survival and progression-free survival for the combination, especially in the PD-L1 < 1% subgroup. However, in the PD-L1 ≥ 1% subgroup, the combination did not achieve statistical significance for OS benefit and showed increased rates of serious adverse events and drug-related adverse events. Consequently, the benefit-risk assessment remained positive only for PD-L1 < 1% patients, concluding a negative benefit-risk for the PD-L1 ≥ 1% population due to unproven additional benefit and increased toxicity.
Key findings — cited to the page
| drug-related SAEs (any grade) (%) | 16.1 % | · p.42 |
| all-causality AEs leading to DC (any grade) (%) | 23.7 % | · p.42 |
| all-causality SAEs (any grade) (%) | 39.7 % | · p.42 |
| all-causality SAEs (Grade 3-4) (%) | 24.5 % | · p.42 |
| drug-related SAEs (Grade 3-4) (%) | 11.3 % | · p.42 |
| drug-related SAEs (Grade 3-4) (%) | 5.3 % | · p.42 |
| folliculitis (any grade) (%) | 1.4 % | · p.45 |
| hypothyroidism (any grade) (%) | 17.7 % | · p.45 |
| all-causality SAEs (any grade) (%) | 34.5 % | · p.42 |
| all-causality SAEs (Grade 3-4) (%) | 31.3 % | · p.42 |
| drug-related SAEs (any grade) (%) | 8.4 % | · p.42 |
| all-causality AEs leading to DC (any grade) (%) | 17.3 % | · p.42 |
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 →