U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Approvals and Databases
  5. Drug Trials Snapshot: OPDUALAG
  1. Drug Approvals and Databases

Drug Trials Snapshot: OPDUALAG

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the OPDUALAG Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

OPDUALAG (nivolumab and relatlimab-rmbw)
(Op-DEW-uh-lag)
Bristol Myers Squibb
Original Approval date: March 18, 2022

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

OPDUALAG is a fixed-drug combination of nivolumab and relatlimab. OPDUALAG is used to treat adult and pediatric patients 12 years of age or older with a type of skin cancer called melanoma that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic).

How is this drug used?

OPDUALAG is injected into the vein (intravenous infusion) by a healthcare provider once every four weeks. It takes about 30 minutes to receive an OPDUALAG infusion.

Who participated in the clinical trials?

The FDA approved OPDUALAG based on evidence from one clinical trial of 714 patients with previously untreated metastatic or unresectable melanoma. The trial was conducted at 114 sites across the US and 24 other countries. This same clinical trial was used to assess efficacy and safety.

What are the benefits of this drug?

The benefit of OPDUALAG was evaluated by measuring the length of time tumors did not grow after treatment (progression-free survival or PFS). In the clinical study, the progression-free survival for patients taking OPDUALAG was about 10.1 months compared to 4.6 months for patients taking nivolumab.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: OPDUALAG works similarly in males and females.
  • Race: The number of patients of races other than White was small; therefore, differences in how OPDUALAG worked among races could not be determined.
  • Age: OPDUALAG worked similarly in patients below and above 65 years of age.

What are the possible side effects?

The most common side effects of OPDUALAG are muscle and bone pain, tiredness, rash, itching, and diarrhea. The most common laboratory abnormalities include decreased red blood cell and white blood cell counts, increased liver function test results, and decreased salt (sodium) in the blood.

OPDUALAG can cause serious immune reactions such as inflammation of the organs and tissues of the body (including the lungs, gut, liver, kidneys, hormonal glands, skin, or heart) or allergic reactions to the drug infusion.

Were there any differences in side effects of the clinical trials among sex, race, and age?

  • Sex: The occurrence of side effects was similar in males and females
  • Race: The number of patients of races other than White was small; therefore, differences in the occurrence of side effects among races could not be determined.
  • Age: The occurrence of side effects was similar in patients below and above 65 years of age.

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many men and women were enrolled in the clinical trials.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were enrolled in the clinical trial. In total, 416 (58%) male and 298 (42%) female patients participated in the clinical trial.

Source: Clinical Trial Data

Figure 2 summarizes the percentage of patients by race enrolled in the clinical trial.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, American Indian or Alaskan, and other patients were in the clinical trial. In total, 690 (97%) White patients, 5 (<1%) Black or African American patients, 1 (<1%) American Indian or Alaskan patients, 12 (2%) Other patients, and 7 (<1%) patients who did not report a race participated in the clinical trial. Table 6 summarizes the baseline demographics by race.

Source: Clinical trial data

Table 6: Baseline Demographics by Race in the Clinical Trial

Race

Number of Patients

Percentage

White

690

97

Black or African American

5

<1

American Indian or Alaska Native

1

<1

Other

11

2

Not Reported

7

<1

Source: Clinical trial data

Figure 3 summarizes the percentage of patients by age group enrolled in the clinical trial.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 383 (54%) patients below the age of 65 years of age and 331 (46%) patients above the age of 65 years of age participated in efficacy population of the clinical trial.

Source: Clinical trial data

Figure 4 below summarizes how many patients by ethnicity were in the trial.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many patients by ethnicity were in the clinical trial. In total, 47 (6%) patients were Hispanic or Latino, 291 (41%) patients were not Hispanic or Latino, and 376 (53%) patients not reporting an ethnicity participated in the clinical trial.

Source: Clinical trial data

How were the trials designed?

The efficacy and safety of OPDUALAG were evaluated in a multicenter, randomized, double-blind trial of 714 patients with previously untreated unresectable or metastatic melanoma. The trial compared patients who were randomly assigned to receive either OPDUALAG (nivolumab 480 mg and relatlimab 160 mg) or nivolumab 480 mg intravenously every four weeks. The treatment continued until cancer progression or development of intolerable side effects. The benefit of OPDUALAG in comparison to nivolumab was assessed by the length of time that patients lived without disease progression (progression free survival or PFS).

Additional efficacy outcome measures were overall survival (OS) and overall response rate (ORR). Safety assessments were performed on all patients who received at least one dose of study drug.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

LINK TO DRUG PACKAGE INSERT: OPDUALAG

Back to Drug Trials Snapshots

Back to Top