Yervoy (ipilimumab) is a cancer medication developed by Bristol-Myers Squibb. It is approved in the U.S. and the European Union for the treatment of advanced stage melanoma — a type of skin cancer — in adults and adolescents, age 12 and older. Yervoy also is used by adults with advanced renal carcinoma or kidney cancer.
In addition to stand-alone treatment, Yervoy also has been approved as combination therapy for different cancer types. In July 2018, the FDA granted accelerated approval to Yervoy in combination with Opdivo (nivolumab) by Bristol-Myers Squibb as a treatment for two types of metastatic colorectal cancer in patients 12 and older. The combination has also been approved for untreated patients with advanced renal carcinoma (kidney cancer). Both the FDA and European medicines agency (EMA) also approved Yervoy-Opdivo combination for the treatment for advanced metastatic melanoma.
How Yervoy works
Yervoy is an immunotherapeutic agent, meaning that it harnesses the body’s own immune system to fight and clear cancer cells. Furthermore, it helps the body “remember” this function even after the treatment is complete, making it self-sufficient to remove cancer cells.
A type of white blood cells called T-cells plays a vital role in regulating the immune system. These cells attack foreign substances, including cancer cells, and help in their clearance. There are proteins on the surface of these T-cells, such as CTLA-4, that serve as checkpoints that can switch off or turn on their function.
Yervoy is administered into the patient’s bloodstream through a vein at an outpatient clinic. Hospital stay usually is not required. Its dosage is calculated based on the cancer being treated and the patient’s weight. For metastatic melanoma, up to four doses of 3 mg Yervoy per kilogram, every three weeks is the regular dosage. Each session can take up to 90 minutes for complete administration of the treatment.
Yervoy in clinical trials
Several studies have shown Yervoy treatment, either alone or as a combination therapy, to be effective in helping patients with advanced melanoma or renal cancer live longer. Descriptions of two pivotal studies follow:
In a multinational Phase 3 (NCT01515189) clinical trial, 727 patients with untreated or previously treated inoperable Stage 3 or 4 melanoma were randomly divided into two groups to receive either 3 mg/kg (365 patients) or 10 mg/kg (362) of Yervoy. The median follow-up of the study was 14.5 months for the 10 mg/kg group and 11.2 months for the 3 mg per kg group. Researchers found that a higher dose of Yervoy significantly increased the overall survival of the patients (15.7 months) compared with the low dose (11.2 months), but it also was related to increased side effects.
A Phase 3 study (NCT00636168) assessed the effect of Yervoy treatment at 10 mg/kg on overall survival, recurrence-free survival, and metastasis-free survival in 475 patients who underwent complete removal of Stage 3 cutaneous melanoma tumors. The results were compared to 476 patients who received a placebo. Yervoy treatment resulted in an increased rate of regression-free survival, metastasis-free survival, and overall survival compared with the placebo when administered as a follow-up treatment to surgery (called “adjuvant therapy”). This study supported the FDA approval of Yervoy as the only immune checkpoint treatment as adjuvant therapy.
Other information and side effects
A detailed discussion with one’s doctor about Yervoy therapy and the use of immunosuppressive treatments is critical to understand the adverse side effects and possible cross-reaction between treatments. Some patients may not be eligible for Yervoy treatment, such as those seeking treatment for active autoimmune conditions like rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or lupus.
Yervoy treatment aims for an active immune system to clear the cancer cells. Vaccination during, or six months after, treatment is not recommended because the immune system may render the vaccination ineffective.
The most common side effects of Yervoy therapy include tiredness, nausea, diarrhea, rash, decreased appetite, itching, and stomach pains.
Yervoy cause may other complication when used in combination with Opdivo. These include thyroid hormone imbalance, joint pain, gut inflammation or colitis, headache, breathing problems, and fever.
The effect of Yervoy treatment on fertility is not known. The treatment may harm the fetus in pregnant women, so it is important to discuss pregnancy plans and effective contraception options with a doctor before starting the treatment.
Breastfeeding is not advised while undergoing Yervoy therapy because of the possibility of passing the medication to the baby through breast milk.
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