What is the use of Nivolumab (Opdivo)?

From the Guidelines

Nivolumab is a highly effective treatment for various types of cancer, including melanoma and kidney cancer, and should be considered as a first-line treatment option due to its ability to improve overall survival and quality of life, as demonstrated in the most recent and highest quality study 1.

Key Points

• Nivolumab works by blocking the PD-1 protein on T cells, enhancing the immune system's ability to detect and destroy cancer cells.
• The recommended dosing regimen for nivolumab is 3 mg/kg every 2 weeks, or in combination with ipilimumab, 3 mg/kg and 1 mg/kg respectively, every 3 weeks for four cycles, followed by nivolumab 3 mg/kg every 2 weeks.
• Common side effects include fatigue, rash, itching, diarrhea, and nausea, while more serious immune-related adverse effects can occur, such as inflammation in organs like the lungs, liver, or endocrine glands.
• Regular monitoring of liver and thyroid function is necessary during treatment, and patients should report any new or worsening symptoms promptly to their healthcare provider.

Efficacy and Safety

• A 2022 study found that nivolumab plus ipilimumab improved overall survival and progression-free survival compared to sunitinib in patients with previously untreated advanced renal cell carcinoma 1.
• The study also found that nivolumab plus ipilimumab was associated with fewer patient-reported symptoms and better health-related quality of life compared to sunitinib.
• Grade 3 or higher adverse events were seen in 47.3% of patients treated with nivolumab plus ipilimumab, compared to 64.1% of patients treated with sunitinib.

Treatment Considerations

• Nivolumab should be considered as a first-line treatment option for patients with advanced melanoma or kidney cancer, due to its ability to improve overall survival and quality of life.
• Patients should be closely monitored for side effects and have regular liver and thyroid function tests during treatment.
• The combination of nivolumab and ipilimumab may be considered for patients with previously untreated advanced renal cell carcinoma, due to its improved efficacy and safety profile compared to sunitinib.

From the FDA Drug Label

OPDIVO is a prescription medicine used to treat: • adults and children 12 years of age and older with a type of skin cancer called melanoma: • adults with a type of lung cancer called non-small cell lung cancer (NSCLC) • adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma • adults with a type of kidney cancer called renal cell carcinoma (RCC). • adults with a type of blood cancer called classical Hodgkin lymphoma (cHL). • adults with head and neck cancer (squamous cell carcinoma) • adults with a type of cancer of the lining of the urinary tract called urothelial carcinoma (UC). • adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer).

Nivolumab (OPDIVO) is used to treat various types of cancer, including:

• Melanoma
• Non-small cell lung cancer (NSCLC)
• Malignant pleural mesothelioma
• Renal cell carcinoma (RCC)
• Classical Hodgkin lymphoma (cHL)
• Head and neck cancer (squamous cell carcinoma)
• Urothelial carcinoma (UC)
• Colorectal cancer 2

From the Research

Nivolumab Overview

• Nivolumab is a monoclonal antibody that inhibits programmed cell death 1, approved by the US Food and Drug Administration for treating advanced melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and other malignancies 3.
• It has been shown to be associated with long-term survival in a subset of heavily pretreated patients with advanced melanoma, RCC, or NSCLC 3.

Pharmacokinetics and Efficacy

• A prospective cohort study found that nivolumab pharmacokinetics are affected by gender, body surface area (BSA), and serum albumin, with women having 22% lower clearance compared to men 4.
• The study also found a clearance-response relationship in NSCLC, with higher clearance associated with progressive disease, but not in melanoma 4.
• Nivolumab has been shown to improve overall survival, progression-free survival, and overall response rate for advanced/recurrent NSCLC, with combination therapy being superior to monotherapy 5.

Safety and Tolerability

• Nivolumab has been found to be safe and effective in patients with advanced NSCLC, with no enhanced risk of commonly reported adverse events, but an increased risk of immune-related adverse events 5.
• A retrospective study found that treatment with nivolumab beyond progression is associated with improved survival in patients with NSCLC, with no safety concerns emerging in patients who continued treatment beyond progression 6.

Clinical Applications

• Nivolumab has been approved for the treatment of patients with metastatic melanoma, squamous and nonsquamous NSCLC, Hodgkin disease, and RCC 7.
• It may be beneficial for patients with NSCLC in both first-line and second-line treatment, and its efficacy is not correlated with PD-L1 expression levels 5.