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Indication

Opdualag™ showed
a durable and superior
progression-free survival* benefit
vs nivolumab monotherapy1-3

*Kaplan-Meier estimate.1

Actor portrayal.

Opdualag more than doubled median progression-free survival* vs nivolumab monotherapy1-3

PFS per BICR at the 33.8-month median follow-up

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Opdualag™ progression-free survival (PFS) per BICR, graph

Symbols represent censored observations.

Median PFS at the 13.2-month median primary analysis (95% CI)1,3:

  • Opdualag: 10.1 months (6.4–15.7)
  • Nivolumab: 4.6 months (3.4–5.6)

Separation of PFS curve was early—at time of first scan (at 3 months)—and sustained over time.1,3

Median PFS at 33.8-month median follow-up (95% CI)2:

  • Opdualag: 10.2 months (6.5–15.4)
  • Nivolumab: 4.6 months (3.5–6.5)

*Kaplan-Meier estimate.1 Based on stratified Cox proportional hazard model.1 Based on stratified log-rank test.1

BICR=blinded independent central review; CI=confidence interval; HR=hazard ratio; mo=month; PFS=progression-free survival.

Continue scrolling for BRAF mutant data

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 status4

  • Among preferred regimens, combination checkpoint blockade is preferred over anti–PD-1 monotherapy4*
  • BRAF/MEK combination was moved from Category 1 “preferred regimens” to “other recommended regimens”4†

*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.4 High-volume symptomatic disease BRAF+ patients may benefit from BRAF/MEK inhibition, as opposed to combination immunotherapy.4 Otherwise, nivolumab + ipilimumab is preferred first-line over BRAF/MEK therapy due to OS benefit.4

Category 1=Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate4; 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 outcomes4; Preferred intervention=Interventions that are based on superior efficacy, safety, and evidence; and when appropriate, affordability.4

PFS per BICR across pre-specified subgroups and stratification factors at the 33.8-month median follow-up2,5

gradient

Based on an exploratory analysis.

BRAF=B-Raf proto-oncogene; ECOG PS=Eastern Cooperative Oncology Group Performance Status; LAG-3=lymphocyte-activation gene-3; LDH=lactate dehydrogenase; PD-L1=programmed death-ligand 1; ULN=upper limit of normal.

BRAF mutant PFS per BICR at the 33.8-month median follow-up2,5

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BRAF mutant PFS pcer BICR, graph

Symbols represent censored observations. Based on an exploratory analysis.

BRAF mutant PFS at the 33.8-month median follow-up5:

  • Median PFS (mos, 95% CI):
    • Opdualag: 10.2 (4.6–19.6)
    • Nivolumab: 4.6 (3.0–6.9)
  • HR vs nivolumab (95% CI): 0.72* (0.54–0.96)2

BRAF wild-type PFS at the 33.8-month median follow-up5:

  • Median PFS (mos, 95% CI):
    • Opdualag: 12.0 (6.4–18.3)
    • Nivolumab: 4.6 (3.0–7.6)
  • HR vs nivolumab (95% CI): 0.84* (0.67–1.06)2

*Based on unstratified Cox proportional hazard model.5

Median Overall Survival for Opdualag was 51.0 months vs 34.1 months for nivolumab monotherapy1,2*

OS at the 33.8-month median follow-up

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Opdualag™ overall survival (OS), graph

Symbols represent censored observations.

At the 33.8-month median follow-up:

  • Median OS (mos, 95% CI)2
    • Opdualag: 51.0 (34.0–NR)
    • Nivolumab: 34.1 (25.2–44.7)

At the 19.3-month median primary analysis*:

  • A 20% risk reduction of death was observed with Opdualag vs nivolumab monotherapy; HR vs nivolumab: 0.80 (95% CI: 0.64–1.01); P=0.05931,6‡
  • Primary analysis for the secondary endpoint of OS was not significant (P=0.0593); threshold for significance was P<0.043021,6

*At the 19.3-month median primary analysis, OS was not statistically significant.1 Based on stratified Cox proportional hazard model.1 Based on stratified log-rank test.1

NR=not reached; OS=overall survival.

Higher overall response rates were observed for Opdualag vs nivolumab monotherapy1,2

ORR per BICR at the 33.8-month median follow-up

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Opdualag™ overall response rate (ORR), chart

At the 33.8-month median follow-up:

  • Median DOR was not yet reached for both Opdualag and nivolumab5
    • mDOR for Opdualag: NA (95% CI, months: 46.9–NA)
    • mDOR for nivolumab: NA (95% CI, months: 39.8–NA)
  • ORR for Opdualag was 44% (n=155/355; 95% CI: 38–49) vs 34% (n=121/359; 95% CI: 29–39) for nivolumab2
    • CR was 20% (n=70/355) for Opdualag vs 19% (n=67/359) for nivolumab
    • PR was 24% (n=85/355) for Opdualag vs 15% (n=54/359) for nivolumab
  • Median time to response for Opdualag was 2.79 months (1.2–20.1) and for nivolumab was 2.79 months (1.7–42.3)5

At the 19.3-month median primary analysis*:

  • ORR for Opdualag was 43% (n=153/355; 95% CI: 38–48) vs 33% (n=117/359; 95% CI: 28–38) for nivolumab1,6
    • CR was 16% (n=58/355) for Opdualag vs 14% (n=51/359) for nivolumab1
    • PR was 27% (n=95/355) for Opdualag vs 18% (n=66/359) for nivolumab1

*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; DOR=duration of response; mDOR=median duration of response; NA=not available; ORR=overall response rates; PR=partial response.

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Safety Data

Find information about adverse reactions seen in the clinical trial.

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Dosing Schedule

Learn more about the dosing schedule for this fixed-dose combination therapy.

References:

  1. Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Tawbi HA, Hodi FS, Lipson EJ, et al. Nivolumab plus relatlimab vs nivolumab in previously untreated metastatic or unresectable melanoma (RELATIVITY-047): Overall survival and melanoma-specific survival outcomes at 3 years. Poster presentation at: Annual Meeting of the American Society of Clinical Oncology; May 31-June 2, 2024; Chicago, IL. Poster 9524.
  3. 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.
  4. 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.
  5. Data on file. BMS-REF-Rela-0014. Princeton, NJ. Bristol-Myers Squibb Company; 2024.
  6. 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 at ASCO Plenary Series 2022.


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1425-US-2400192 09/24