For the 1L treatment of unresectable or metastatic melanoma
Dual I-O efficacy paired
with a similar safety profile
as nivolumab monotherapy for patients regardless of
BRAF status1*
Actor portrayals.
At the 13.2-month median primary analysis, the median progression-free survival† was 10.1 months (95% CI: 6.4–15.7) for Opdualag™ (nivolumab and relatlimab-rmbw) vs 4.6 months (95% CI: 3.4–5.6) for nivolumab‡ (HR=0.75§; 95% CI: 0.62–0.92); P=0.0055.1II
*At the 13.2-month median primary analysis, PFS† in BRAF MT: HR=0.74¶ (95% CI: 0.54–1.03); PFS† in BRAF WT: HR=0.76¶ (95% CI: 0.59-0.98).2 †Assessed by BICR.1,2 ‡Kaplan-Meier estimate.1 §Based on stratified Cox proportional hazard model.1 IIBased on stratified log-rank test.1 ¶Based on unstratified Cox proportional hazard model.2
1L=first-line; BICR=blinded independent central review; BRAF=B-Raf proto-oncogene; CI=confidence interval; HR=hazard ratio; I-O=immuno-oncology; MT=mutant; PFS=progression-free survival; WT=wild-type.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
First-line, NCCN Category 1 Preferred
Nivolumab and Relatlimab-rmbw (Opdualag™) is recommended as a Category 1, preferred first-line treatment for unresectable or metastatic melanoma, regardless of BRAF status3
- Among preferred regimens, combination checkpoint blockade is preferred over anti–PD-1 monotherapy3*
- BRAF/MEK combination was moved from Category 1 “preferred regimens” to “other recommended regimens”3†
*Considerations for using combination nivolumab/ipilimumab or nivolumab and relatlimab-rmbw versus PD-1 monotherapy include: Patient willingness to take on a higher risk of treatment-related toxicities (immune-related adverse events [irAEs]); absence of comorbidities or autoimmune processes that would elevate the risk of irAEs; and patient social support and preparedness to work with medical team to handle toxicities.3 †High-volume symptomatic disease BRAF+ patients may benefit from BRAF/MEK inhibition, as opposed to combination immunotherapy.3 Otherwise, nivolumab + ipilimumab is preferred first-line over BRAF/MEK therapy due to OS benefit.3
Category 1=Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate3; MEK=mitogen-activated extracellular signal-regulated kinase; NCCN=National Comprehensive Cancer Network® (NCCN®); Other recommended intervention=other interventions that may be somewhat less efficacious, more toxic, or based on less mature data; or significantly less affordable for similar outcomes3; Preferred intervention=Interventions that are based on superior efficacy, safety, and evidence; and when appropriate, affordability.3
NEW
Efficacy Data
Explore the 33.8-month median follow-up data from the clinical trial.
Safety Data
Find information about adverse reactions seen in the clinical trial.
Dosing Schedule
Learn more about the dosing schedule for this fixed-dose combination therapy.
References:
- Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
- Data on file. BMS-REF-Rela-0016. Princeton, NJ. Bristol-Myers Squibb Company; 2022.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Cutaneous V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed May 3, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
