Nivolumab and relatlimab-rmbw (Opdualag)

How is the drug name pronounced?

Nivolumab and relatlimab-rmbw: nih-VOL-yoo-mab and reh-LAT-lih-mab

Opdualag: Op-DOO-ah-lag


What cancer(s) does this drug treat?

Melanoma

Opdualag is approved for:

  • adult and pediatric patients who are 12 years or older with melanoma that cannot be removed by surgery, or that has spread to other parts of the body.

Limitations of use:

Age: The safety and efficacy of Opdualag have not been established in patients under 12 years of age or less than 40 kg in body weight.
Pregnancy/Breastfeeding: Opdualag may cause harm to the fetus and is not recommended for use during pregnancy. Women are advised to use effective contraception during treatment with Opdualag and for at least 5 months after the last dose of Opdualag. The risks associated with Opdualag in a breastfed child are not known and cannot be ruled out. Due to the potential for serious reactions in the breastfed child, patients are advised not to breastfeed during treatment with Opdualag and for 5 months after the last dose of Opdualag.
Complications of stem cell transplant: Serious and life-threatening complications that can lead to death can occur in patients who have received a stem cell transplant from a stem cell donor before or after being treated with Opdualag. The benefit of treatment with Opdualag versus the possible risk of transplant-related complications (especially in patients with a history of graft-versus-host disease) should be carefully considered.


What type of immunotherapy is this?

Checkpoint blockade

  • PD-1 blockade
  • LAG3 blockade

How does this drug work?

Targets:

  • PD-1
  • LAG3

Opdualag is a checkpoint blockade therapy consisting of two types of therapeutic antibodiesnivolumab and relatlimab. Nivolumab attaches to a molecule called PD-1, while relatlimab binds to a molecule called LAG3, both of which are present on the surfaces of T cells – the primary immune cells involved in killing cancer cells. In healthy tissues, PD-1 and LAG3 act as checkpoints or brakes that keep T cells from creating an immune reaction that gets out of control. However, cancers can hijack this safety mechanism and prevent T cells from killing the cancer cells. This can happen when cancer cells or other cells within the tumor mass display molecules on their surface that interact with PD-1 or LAG3, as these interactions cause the T cells to become inactive, preventing them from attacking the cancer cells. Nivolumab and relatlimab bind to PD-1 and LAG3, respectively, preventing such interactions and allowing T cells to remain active and attack the cancer cells. Combining nivolumab and relatlimab into Opdualag results in an even stronger effect on the anti-cancer T cells than use of either antibody alone.

Illustration showing how Opdualag works


How is this drug given to the patient?

Opdualag is administered via a tube in the vein (intravenous infusion, or i.v.) once every 4 weeks. Each infusion of Opdualag lasts for about 30 minutes and does not require a hospital stay.


What are the observed clinical results?

It is important to keep in mind that each patient’s actual outcome is individual and may be different from the results found in the clinical studies. In addition, with immunotherapy, sometimes it takes several months for responses to be observed.

Advanced melanoma

In a clinical trial, 714 patients with advanced melanoma that had spread to other parts of the body (metastatic) or could not be removed by surgery (unresectable), and who had not received prior treatment for their advanced disease were treated with either Opdualag or nivolumab (Opidvo). At a median follow-up of 19 months:

Results after treatment with Opdualag vs Opdivo alone (diagram)


What are the potential side effects?

The most common side effects of Opdualag include muscle and joint pain, fatigue, low white blood cell counts, abnormal liver function test results, rash, itchiness, diarrhea, and abnormal blood test results.

Opdualag can cause the patient’s T cells to attack healthy cells throughout the body. Because of this, Opdualag can cause side effects that can become serious or life-threatening, and may lead to death. Some of the serious side effects related to Opdualag include inflammation of the lungs, liver, brain, kidneys (which can lead to kidney failure), colon (which can result in tears or holes in the intestine), or heart. Additionally, problems can arise with hormone glands (including thyroid, pituitary, and adrenal glands, as well as the pancreas). Opdualag may cause Type 1 diabetes. Skin rash (which could become severe and life-threatening), and reactions related to the infusion may also occur. Symptoms of an infusion-related reaction may include chills or shaking, itching or rash, flushing, shortness of breath, dizziness, lightheadedness, fever, and back or neck pain.

Patients who experience side effects should report them to their healthcare provider who can then initiate actions to limit or reverse the side effects. For a more complete list of possible side effects, see the full prescribing information.


Additional Information

Manufacturer

Bristol-Myers Squibb

Approval

FDA

Other references: 

Last updated: May 31, 2022


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