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opdualag
opdualag

Safety

Viktig sikkerhets- og forskrivningsinformasjon

Median follow-up was 33.8 months
Opdualag safety summary in treatment-naïve, advanced melanoma1*

 

*ITT-population. EU approved indication: PD-L1 <1%.

 

 

 

Safety_summary_one

aIncludes AEs of any grade occurring in ≥1% of patients considered by investigators to be potentially immune mediated that met the following criteria: occurred within 100 days of last dose, regardless of causality; treated with immune-modulating medication with no clear alternate aetiology; or had an immune-mediated component.

NOTE. Data are No. (%) unless otherwise specified.
IMAE – immune-mediated AE.

aIMAEs included AEs of any grade that occurred in at least 1% of patients in the nivolumab plus relatlimab arm, that were considered by investigators to be potentially immune-mediated, and that met the following criteria: occurred within 100 days after the last dose (regardless of causality) and were treated with immune-modulating medication with no clear alternate cause or had an immune-mediated component; b Treatment-related deaths: nivolumab plus relatlimab (n = 4): hemophagocytic lymphohistiocytosis, acute edema of the lung, pneumonitis, and multiorgan failure; nivolumab (n = 2): sepsis and myocarditis, and worsening pneumonia. No new treatment-related deaths were reported since the last database lock.

Reference:

  1. Tawbi HA, et al. Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047 (2024). J Clin Oncol. 2024 Dec 13:JCO2401124. https://doi.org/10.1200/JCO.24.01124.


1425-NO-2500004 February 2025

We refer to the SmPC for full information on Opdualag®