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Now APPROVED

For the 1L treatment of unresectable or metastatic melanoma

Dual I-O efficacy paired
with a similar safety
profile as
nivolumab to
move even more patients
beyond monotherapy1*

Median progression-free survival was 10.1 months for Opdualag vs 4.6 months for
nivolumab (HR=0.75; 95% CI: 0.62–0.92); P=0.0055.1

*Nivolumab monotherapy.

Efficacy

Opdualag was evaluated in a global, randomized,
phase 3 trial vs nivolumab monotherapy1,2

RELATIVITY-047: First phase
3 trial confirming the benefits
of an anti–LAG-3 therapy
in combination with the
PD-1 inhibitor, nivolumab1

Opdualag Phase 3 Trial Design Opdualag Phase 3 Trial Design

Median duration of treatment for Opdualag after 13.2 months of follow-up was 5.6 months, and at 19.3 months of follow-up was 8.3 months.2,3 Treat until disease progression or unacceptable toxicity.1

Inclusion criteria1,2:
  • Histologically confirmed Stage III
    (unresectable) or Stage IV
    melanoma
  • Expression of LAG-3 and PD-L1 that could be evaluated in tumor tissue
Exclusion criteria1:
  • Patients with active autoimmune disease
  • Medical conditions requiring systemic
    treatment with
    moderate- or high-dose
    corticosteroids or
    immunosuppressive
    medications
  • Patients with uveal melanoma
  • Patients with active or untreated brain or leptomeningeal metastases
  • *Patients were allowed to receive prior adjuvant and neoadjuvant melanoma therapy. Anti-PD-1, anti-CTLA-4, or BRAF-MEK was allowed as long as there was at least 6 months between the last dose of therapy and date of recurrence; interferon therapy was allowed as long as the last dose was at least 6 weeks prior to randomization.1
  • PD-1 expression (≥1% vs <1%) using PD-L1 IHC 28-8 pharmDx test.1
  • LAG-3 expression (≥1% vs <1%) using a clinical trial assay.1
  • §The final analysis of OS was not statistically significant.1

1L=first-line; AJCC=American Joint Committee on Cancer; BICR=blinded independent central review; BRAF=B-Raf proto-oncogene; CI=confidence interval; CTLA-4=cytotoxic T-lymphocyte-associated antigen-4; ECOG PS=Eastern Cooperative Oncology Group Performance Status; HR=hazard ratio; IHC=immunohistochemistry; IV=intravenous; LAG-3=lymphocyte-activation gene-3; M=metastases; MEK=mitogen-activated extracellular signal-regulated kinase; ORR=overall response rate; OS=overall survival; PD-1=programmed death protein-1; PD-L1=programmed death-ligand 1; PFS=progression-free survival; PS=performance status; Q4W=every 4 weeks; RECIST=Response Evaluation Criteria in Solid Tumors.

More than doubled median progression-free survival*†‡ vs nivolumab monotherapy1,2

Progression-free survival1,2*†‡
Progression-Free Survival with Opdualag vs nivolumab Progression-Free Survival with Opdualag vs nivolumab
  • Superior progression-free survival (PFS)*†‡ with Opdualag vs nivolumab (HR=0.75§; 95% CI: 0.62–0.92); P=0.00551,2||
    • Median follow-up was 13.2 months1,2
  • Separation of PFS curve was early—at time of first scan (at 3 months) and sustained over time1,2
  • *Assessed by BICR.1
  • Final PFS analysis.1
  • Kaplan-Meier estimate.1
  • §Based on stratified Cox proportional hazard model.1
  • ||Based on stratified log-rank test.1

Median OS* for Opdualag has not yet been reached vs 34.1 months for nivolumab monotherapy1,3

Overall survival*
Overall Survival with Opdualag vs nivolumab Overall Survival with Opdualag vs nivolumab

Symbols represent censored observations.

  • Opdualag lowered the risk of death by 20% at 19.3 months of median follow-up vs nivolumab monotherapy* (HR=0.80; 95% CI: 0.64–1.01)1,3
  • At a median follow-up of 19.3 months, the final analysis for the secondary endpoint of OS was not significant (P=0.0593); threshold for significance was P<0.043023
  • *At the time of the final OS analysis, which was event-driven and occurred after the final PFS analysis.1
  • Based on stratified Cox proportional hazard model.1
  • Based on stratified log-rank test.1
  • §Not significant at alpha level 0.04302.1

mOS=median overall survival; NS=not significant.

Higher overall response rates*†‡ were observed vs nivolumab monotherapy1

Overall response rate1*‡
Overall Response Rate (ORR) with Opdualag vs nivolumab Overall Response Rate (ORR) with Opdualag vs nivolumab
  • Overall response rate*†‡ for Opdualag was 43% (n=153/355; 95% CI: 38–48) vs 33% (n=117/359; 95% CI: 28–38) for nivolumab1
  • Median DOR was not yet reached for both Opdualag and nivolumab3
  • Median time to response was 2.79 months for both Opdualag and nivolumab3
  • *Assessed by BICR.1
  • 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

DOR=duration of response; ORR=overall response rate.

Safety

No additional safety events and similar rates of most common Grade 3/4 adverse reactions vs nivolumab monotherapy1,2

Adverse reactions occurring in ≥15% of patients receiving Opdualag or nivolumab monotherapy arm1
Opdualag Adverse Reactions Chart
  • The only Grade 3/4 increases greater than 1% vs nivolumab monotherapy were fatigue (1.4%) and musculoskeletal pain (2.5%)1
  • Treatment-related discontinuation rates were 14.6% with Opdualag vs 6.7% with nivolumab2
    • Grade 1/2 discontinuation rate was 6.1% with Opdualag vs 3.6% with nivolumab
    • Grade 3/4 discontinuation rate was 8.5% with Opdualag vs 3.1% with nivolumab
  • Toxicity was graded per NCI CTCAE v5.
  • *Clinically relevant adverse reactions in <15% of patients who received Opdualag included vitiligo, adrenal insufficiency, myocarditis, and hepatitis.1
  • Includes multiple terms.1

NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

Choose Opdualag for your
appropriate
1L metastatic
melanoma patients

See Full Prescribing Information

Dosing

Opdualag is a fixed-dose combination administered as
a 30-minute intravenous infusion every 4 weeks1

Opdualag Dosing Schedule Opdualag Dosing Schedule
  • *12 years of age or older who weigh at least 40 kg. A recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age has not been established.

A single, fixed-dose infusion may help reduce preparation and infusion
times and could help minimize potential risk of administration errors2

  • Opdualag is a fixed-dose combination: a co-formulation of 2 active ingredients in a single vial administered as a single infusion1,4
  • A single-dose vial contains 240 mg of nivolumab and 80 mg of relatlimab per 20 mL (one dose will require 2 vials)1

Select Important Safety Information

Infusion-Related Reactions

Opdualag can cause severe infusion-related reactions. Discontinue Opdualag in patients with severe or life-threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild to moderate infusion-related reactions. In patients who received Opdualag as a 60-minute intravenous infusion, infusion-related reactions occurred in 7% (23/355) of patients.

Learn more about Opdualag
fixed-dose combination

Download dosing guide