Nivolumab (Opdivo)

How is this drug name pronounced?

Nivolumab: nih-VOL-yoo-mab

Opdivo:op-DEE-voh


What cancer(s) does this drug treat?

Opdivo has been approved for a number of cancer types and stages, in some cases as a single therapy and in some cases in combination with ipilimumab (Yervoy), another immunotherapy.

Opdivo is approved for:

Melanoma
Lung cancer
Kidney cancer
Classical Hodgkin lymphoma
Head and neck squamous cell cancer
Bladder and urinary tract (urothelial cell) cancer
Colorectal cancer (MSI-H/dMMR)
Liver cancer

Advanced melanoma

Opdivo is approved for:

  • Patients with advanced melanoma that is metastatic (cancer has spread to other parts of the body from the original cancer site) or cannot be completely removed by surgery. Opdivo may be used by itself or in combination with ipilimumab (Yervoy).
  • Patients with melanoma that was completely removed by surgery. In such cases, Opdivo is used to help keep melanoma from coming back.

Advanced lung cancer

Opdivo is approved for:

  • Patients with non-small cell lung cancer that has spread who have tried chemotherapy containing platinum, and it either did not work or stopped working. If the patient’s tumor has an abnormal EGFR or ALK gene, the patient has to have also tried an FDA-approved therapy for tumors with such abnormal genes prior to receiving Opdivo.
  • Patients with small cell lung cancer that has spread who have been treated with at least two different types of chemotherapy, including one containing platinum, and the treatments did not work or stopped working.

Advanced kidney cancer

Opdivo is approved for:

  • Patients with advanced renal cell carcinoma (kidney cancer) who have received other cancer treatments and whose cancer has grown or spread.
  • Patients with newly diagnosed, previously untreated advanced renal cell carcinoma that has grown or spread may be treated with Opdivo in combination with ipilimumab (Yervoy).

Classical Hodgkin lymphoma

Opdivo is approved for:

  • Adult patients with classical Hodgkin lymphoma that has come back or spread after autologous stem cell transplant(a type of transplant that uses the patient’s own stem cells) and either have received brentuximab vedotin (Adcetris)or have been treated with at least 3 kinds of cancer treatments (including the autologous stem cell transplant).

Head and neck squamous cell cancer

Opdivo is approved for:

  • Patients with head and neck squamous cell carcinoma whose cancer has come back or spread after treatment with chemotherapy that contains platinum.

Advanced bladder and urinary tract (urothelial cell) cancer

Opdivo is approved for:

  • Patients with advanced urothelial carcinoma (the most common type of bladder and urinary tract cancer) that has grown or spread who have been treated with chemotherapy containing platinum, and it did not work or stopped working.

Advanced colorectal cancer (MSI-H/dMMR)

Opdivo is approved for:

  • Adult and pediatric patients 12 years of age and older with colon or rectal cancer that has spread, have a tumor that is microsatellite instability-high (MSI-H)or mismatch repair-deficient (dMMR), and have been treated with a fluoropyrimidine, oxaliplatin, and irinotecan, and the treatment did not work or stopped working. Patients may be treated with Opdivo alone or in combination with ipilimumab (Yervoy).

Advanced liver cancer

Opdivo is approved for:

  • Patients with hepatocellular carcinoma (liver cancer) who have been treated with Nexavar (sorafenib).

Limitations of use

Age: The safety and efficacy of Opdivo in patients with MSI-H/dMMR metastatic colorectal cancer under 12 years of age have not been established. The safety and efficacy of Opdivo in patients under 18 years of age with all other cancer types approved for treatment with Opdivo have not been established.
Pregnancy/Breastfeeding: Opdivo can cause harm to a fetus, and is not recommended for use during pregnancy. The risks associated with Opdivo during breastfeeding are not known and cannot be ruled out; due to the potential for serious adverse reactions in the breastfed child, women are advised not to breastfeed during treatment and for 5 months after the last dose of Opdivo.


What type of immunotherapy is this?

Checkpoint Blockade

  • PD-1 blockade

How does this drug work?

  • Target: PD-1

Opdivo is an antibody that attaches to a molecule called PD-1, which is present on the surface ofT cells– the primary immune cells involved in killing cancer cells. In healthy tissues, PD-1 acts as a brake that keeps T cells from creating an immune reaction that gets out of control. However, cancers can hijack this safety mechanism and prevent T cells from doing their job – killing the cancer cells. This can happen when cancer cells or other cells within the tumor mass display on their surface molecules called PD-L1 or PD-L2. When PD-L1 or PD-L2 interact with PD-1 on T cells, the T cells become inactive and do not attack the cancer cells. Opdivo binds to the PD-1 molecules on T cells in such a way that it prevents the interaction between PD-1 and PD-L1/PD-L2, and allows the T cells to be active and attack the cancer cells.

Illustration that show how Opdivo works


How is this drug given to the patient?

Opdivo is administered via a tube into a vein (intravenous infusion, or I.V.) over 30 minutes and does not require a hospital stay. Opdivo is usually given to the patient either every two, three, or four weeks, depending on the dose and the cancer type.


What are the observed clinical results?

For:

Advanced melanoma (metastatic or not removable by surgery)
Advanced melanoma (completely removed by surgery)
Advanced non-small cell lung cancer (squamous and non-squamous)
Advanced small cell lung cancer
Advanced kidney cancer (previously treated or untreated)
Classical Hodgkin lymphoma
Head and neck squamous cell cancer
Advanced bladder and urinary tract cancer
Advanced colorectal cancer (MSI-H/dMMR)
Advanced liver cancer

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 described below. In addition, with immunotherapy, sometimes it takes several months for responses to be observed.

Advanced melanoma (metastatic or not removable by surgery)

In two clinical studies involving patients with melanoma that was metastatic or could not be removed by surgery who were treated with Opdivo:

Results after treatment with Opdivo (diagram)

In another clinical study comparing the combination of Opdivo and ipilimumab (Yervoy)to Yervoy alone, at a 4-year follow-up:

Comparative results for treatment with Opdivo and Yervoy vs Yervoy alone (diagram)

Advanced melanoma (completely removed by surgery)

In a clinical study of patients with melanoma that was completely removed by surgery who were treated with either Opdivo or ipilimumab (Yervoy) to prevent the cancer from coming back:

Comparative results after treatment with either Opdivo or Yervoy (diagram)

Advanced non-small cell lung cancer (squamous and non-squamous)

In a clinical study of patients with metastatic squamous non-small cell lung cancer treated with either Opdivo or docetaxel (a chemotherapy):

Comparative results after treatment with either Opdivo or docetaxel (diagram)

In another clinical study of patients with metastatic non-squamous non-small cell lung cancer treated with either Opdivo or docetaxel (a chemotherapy):

Comparative results after treatment with either Opdivo or docetaxel (diagram)

Advanced small cell lung cancer

In a clinical study of patients with metastatic small cell lung cancer who were treated with Opdivo:

Results after treatment with Opdivo (diagram)

Advanced kidney cancer (previously treated or untreated)

In a clinical study of patients with previously treated advanced kidney cancer who were treated with either Opdivo or everolimus (an oral chemotherapy):

Comparative results after treatment with either Opdivo or everolimus (diagram)

In a clinical study of patients with previously untreated advanced kidney cancer who were treated with either a combination of Opdivo and ipilimumab (Yervoy)or with sunitinib (an oral chemotherapy):

Comparative results after treatment with Opdivo and Yervoy vs sunitinib (diagram)

Classical Hodgkin lymphoma

In two clinical studies of patients with classical Hodgkin lymphoma who were treated with Opdivo, 1 year after treatment:

Results after treatment with Opdivo (diagram)


Twenty months after treatment:

Results after 20 months (diagram)

Head and neck squamous cell cancer

In a clinical study of patients with head and neck squamous cell cancer treated with Opdivo or with the investigator’s choice of treatment (cetuximab, methotrexate, or docetaxel):

Comparative results with Opdivo vs cetuximab or methotrexate or docetaxel (diagram)

Advanced bladder and urinary tract cancer

In a clinical study of patients with advanced bladder cancer treated with Opdivo:

Results after treatment with Opdivo (diagram)

Advanced colorectal cancer (MSI-H/dMMR)

In a clinical study of patients with microsatellite instability-high (MSI-H)or mismatch repair-deficient (dMMR)colon or rectal (“colorectal”) cancer who were treated with Opdivo or a combination of Opdivo and Yervoy (ipilimumab):

Comparative results between Opdivo alone and Opdivo with Yervoy (diagram)

Advanced liver cancer

In a clinical study of patients with advanced liver cancer treated with Opdivo:

Results after treatment with Opdivo (diagram)


What are the side effects?

The most common side effects of Opdivo include fatigue, rash, pain (in the muscles, bones, joints, back, and stomach area), headache, itching, diarrhea, constipation, nausea, vomiting, decreased appetite, cough, shortness of breath, upper respiratory tract infection, and fever.

Opdivo can cause the patient’s T cells to attack healthy cells throughout the body. Because of this, Opdivo can cause side effects that can become serious or life-threatening, and may lead to death. Some of the serious side effects related to Opdivo include inflammation of the lungs, liver, brain, kidneys (which can lead to kidney failure), or colon (which can result in tears or holes in the intestine). Additionally, problems can arise with hormone glands (including thyroid, pituitary, and adrenal glands, as well as the pancreas). Skin rash (which could become severe and life-threatening), and reactions related to the infusion may also occur. Patients should report any symptoms to their healthcare provider who can then initiate actions to limit or reverse the side effects.

Patients may experience other side effects when Opdivo is used in combination with other treatments. For a more complete list of possible side effects, see the full prescribing information.


Additional information

Manufacturer

Bristol‑Myers Squibb

Approval

FDA and EMA (but different indications, this document is for FDA only)

Other references


Understanding Cancer Immunotherapy Research

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