A dual I-O delivering
durable and superior efficacy*
for 1L mMel patients1,2
Actor portrayal.
*Based on the 13.2-month median final analysis, the primary endpoint of PFS was statistically significant; mPFS† was 10.1 months (95% CI: 6.4–15.7) with Opdualag vs 4.6 months (95% CI: 3.4–5.6) with nivolumab‡ (HR=0.75§; 95% CI: 0.62–0.92; P=0.0055¶).1,3 ¶At the median follow-up of 19.3 months, the final analysis for the secondary endpoint of OS was not statistically significant (HR=0.80; 95% CI: 0.64–1.01; P=0.0593); threshold for significance was P<0.04302.1,4 ORR could not be formally tested based on testing hierarchy and was descriptively analyzed for Opdualag (43%; 95% CI: 38–48) vs nivolumab (33%; 95% CI: 28–38).1,2,4
†Assessed by BICR.1 ‡Kaplan-Meier estimate.1 §Based on stratified Cox proportional hazards model.1
All data shown below is 4-year data based on minimum potential follow-up of 45.3 months.2
Overall survival at 4 years (secondary endpoint)
Opdualag was shown to reduce the risk of death by 23% vs nivolumab2
Symbols represent censored observations.
4-year data2:
- Median OS (95% CI)
- Opdualag: 53.3 months (34.0–NR)
- Nivolumab: 33.2 months (25.2–45.8)
- HR (95% CI): 0.77† (0.64–0.94)
Primary analysis (19.3-month median follow-up)1,4:
- The secondary endpoint of OS was not statistically significant. HR vs nivolumab: 0.80 (95% CI: 0.64–1.01; P=0.0593); threshold for significance was P<0.04302
Endpoints were tested in hierarchical order: PFS, OS, ORR.1
†Based on stratified Cox proportional hazards model.1
1L=first-line; BICR=blinded independent central review; CI=confidence interval; HR=hazard ratio; I-O=immuno-oncology; mMel=metastatic melanoma; mPFS=median progression-free survival; NR=not reached; ORR=overall response rate; OS=overall survival; PFS=progression-free survival.
Progression-free survival per BICR at 4 years (primary endpoint)
Opdualag showed a durable and superior* progression-free survival benefit vs nivolumab2
Symbols represent censored observations.
Separation of PFS curve was early—at the time of first scan (3 months)—and sustained over time5
4-year data2:
- Median PFS (95% CI):
- Opdualag: 10.2 months (6.5–15.7)
- Nivolumab: 4.6 months (3.5–6.5)
- HR (95% CI): 0.78† (0.65–0.93)
*Primary analysis (13.2-month median follow-up)1,2:
- Median PFS (95% CI):
- Opdualag: 10.1 months (6.4–15.7)
- Nivolumab: 4.6 months (3.4–5.6)
- HR (95% CI): 0.75† (0.62–0.92); P=0.0055‡
*Kaplan-Meier estimate.1 †Based on stratified Cox proportional hazards model.1 ‡Based on stratified log-rank test.1
My Path to Opdualag
Discover why Dr. Eric Whitman, a surgical oncologist specializing in melanoma treatment, chooses Opdualag for his patients.
Transcript still to come.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
First-line, NCCN Category 1 Preferred
Nivolumab and Relatlimab-rmbw (Opdualag®) is recommended as an NCCN Category 1, preferred first-line treatment option for unresectable or metastatic melanoma, regardless of BRAF status5
- Among preferred regimens, combination checkpoint blockade is preferred over anti–PD-1 monotherapy5*
- BRAF/MEK combination is recommended as a Category 1, other recommended first-line therapy5†
*Combination immune checkpoint blockade is associated with improved response rate, PFS, and OS compared with anti-PD-1 monotherapy. Considerations for using combination therapy versus monotherapy include: patient’s desire for potentially improved efficacy and willingness to take on a higher risk of toxicity; absence of comorbidities or autoimmune processes that would elevate the risk of irAEs; tumor burden and patient social support and preparedness to work with medical team to handle toxicities.4 †High-volume symptomatic disease BRAF+ patients may benefit from BRAF/MEK inhibition, as opposed to combination immunotherapy. Otherwise, nivolumab + ipilimumab is preferred first-line over BRAF/MEK therapy due to OS benefit.4 Category 1: Based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate; Preferred intervention: Interventions that are based on superior efficacy, safety, and evidence; and when appropriate, affordability; 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 outcomes.5
BRAF=B-raf proto oncogene; irAE=immune-related adverse events; MEK=mitogen-activated protein kinase; NCCN=National Comprehensive Cancer Network® (NCCN®); PD-1=programmed cell death protein-1.
PFS per BICR across patient subgroups with Opdualag2
BRAF mutant median PFS for Opdualag was 10.2 months vs 4.6 months for nivolumab6
4-year data update of BRAF mutant progression-free survival
Symbols represent censored observations. Based on an exploratory analysis.
BRAF mutant PFS 4-year data6:
- Median PFS (95% CI):
- Opdualag: 10.2 months (4.6–23.1)
- Nivolumab: 4.6 months (3.0–6.8)
- HR (95% CI): 0.70* (0.53–0.94)
BRAF wild-type PFS 4-year data6:
- Median PFS (95% CI):
- Opdualag: 12.0 months (6.4–18.3)
- Nivolumab: 4.6 months (3.0–7.6)
- HR (95% CI): 0.83* (0.66–1.04)
*Based on unstratified Cox proportional hazards model.1
Higher overall response rates were observed with 1L Opdualag vs nivolumab (secondary endpoint)2
4-year data update of overall response rate per BICR
mDOR was not yet reached for Opdualag at 4 years
Opdualag mDOR: NR (95% CI, months: 47.7–NR); nivolumab mDOR: 56.0 (95% CI, months: 43.2–NR)2
Primary analysis (19.3-month median follow-up)1,2:
- ORR for Opdualag was 43% (95% CI: 38–48) vs 33% (95% CI: 28–38) for nivolumab
- CR was 16% for Opdualag vs 14% for nivolumab
- PR was 27% for Opdualag vs 18% for nivolumab
4-year data based on minimum potential follow-up of 45.3 months.2
*At the time of the final OS analysis, which was event-driven and occurred after the final PFS analysis.1 †Not formally tested based on the testing hierarchy.1
CR=complete response; mDOR=median duration of response; PR=partial response.
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.
- Lipson EJ, Hodi S, Tawbi H, et al. Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update. Eur J Cancer. 2025:225:115547.
- Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in untreated advanced melanoma. N Engl J Med. 2022;386(1):24-34.
- Long GV, Hodi FS, Lipson EF, et al. Relatlimab and nivolumab vs nivolumab in previously untreated metastatic or unresectable melanoma: overall survival and response rates from RELATIVITY-047 (CA224-047). Oral background as ASCO Plenary Series 2022.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Cutaneous V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 11, 2025. 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.
- Data on file. BMS-REF-Rela-0018. Princeton, NJ: Bristol-Myers Squibb Company; 2025.
