NR = not reached, HR = hazard ratio, CI = confidence interval. 

Reference: 

1. Opdualag SmPC

At the 33.8-month median follow-up
Secondary endpoint: Overall survival (OS) for the ITT population^1,*

Overall survival (OS) of Opdualag vs nivolumab^{1 *}

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

Descriptive analysis. Statistical model for HR: stratified Cox proportional hazards model. Stratified by LAG-3, BRAF mutation status, and AJCC M stage. PD-L1 was removed from stratification because it led to subgrounds with < 10 patients.

CI = confidence interval; HR = hazard ratio; LAG-3 = lymphocyte-activation gene 3; BRAF = B-Raf proto-oncogene; AJCC = American Joint Committee on Cancer; PD-L1 = programmed death ligand; NR = not reached.

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.

Median follow-up 33.8 months¹
Opdualag vs nivolumab PFS, OS and ORR by subgroups^* 
 

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

^aMeasurements shown are the sums of the reference diameters of the target lesions. bM1 HR and 95% CI were not calculated due to small patient numbers.

PFS = progression free survival; OS = overall survival; ORR = objective response rate

1. Supplementary appendix to 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.

At the 33.8-month median follow-up
Melanoma specific survival (MSS) of Opdualag vs nivolumab^1,*

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

Exploratory/post hoc analysis. MSS was defined as the time from randomization to death due to melanoma per investigator assessment, with deaths due to any other reason (including death due to study drug toxicity) being censored. Patients who were alive were censored at their last known alive date. 

^aReasons for death were determined by the investigator.
^bDeath due to toxicity was considered a nonmelanoma death.
^cMost common reasons for ”other” included septic shock, myocardial infraction, stroke, pneumonia, and respitatory insufficienty.

CI = confidence interval; HR = hazard ratio; NR = not reached.
Descriptive analysis

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.