What is the use of Nivolumab (Opdivo)?

From the Guidelines

Nivolumab, in combination with ipilimumab, is the recommended treatment for patients with previously untreated advanced renal cell carcinoma, due to its improved overall survival (OS) and progression-free survival (PFS) rates compared to sunitinib, as shown in the CheckMate 214 trial 1.

Key Points

• Nivolumab is an immunotherapy medication that works by blocking the PD-1 protein on immune cells, enhancing the body's own immune response to recognize and attack cancer cells more effectively.
• The typical administration of nivolumab is intravenously every 2-4 weeks at doses ranging from 240-480 mg, depending on the specific cancer type and treatment protocol.
• Treatment with nivolumab often continues until disease progression or unacceptable toxicity occurs.
• Common side effects of nivolumab include fatigue, rash, itching, diarrhea, and nausea, while more serious immune-related adverse effects can affect the lungs, liver, kidneys, or endocrine system.
• Patients receiving nivolumab should be monitored regularly with blood tests and imaging studies to assess treatment response and potential side effects.
• Before starting treatment, patients should be screened for autoimmune conditions and active infections, as nivolumab can exacerbate these conditions.

Evidence

The CheckMate 214 trial, a phase III study, compared nivolumab plus ipilimumab to sunitinib in patients with previously untreated advanced renal cell carcinoma 1. The results showed that nivolumab plus ipilimumab improved OS and PFS rates compared to sunitinib, with a 52% vs 39% OS probability and a 33% vs 16% PFS probability at a minimum study follow-up of 42 months.

Recommendations

Based on the strongest and most recent evidence, nivolumab in combination with ipilimumab is the recommended treatment for patients with previously untreated advanced renal cell carcinoma, due to its improved OS and PFS rates compared to sunitinib 1. Some key considerations for treatment with nivolumab include:

• Monitoring for immune-related adverse effects and managing them promptly.
• Regular assessment of treatment response and potential side effects through blood tests and imaging studies.
• Screening for autoimmune conditions and active infections before starting treatment.
• Individualized treatment planning based on the specific cancer type, treatment protocol, and patient characteristics.

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.

Efficacy and Safety

• Nivolumab has been found to improve overall survival, progression-free survival, and overall response rate for advanced/recurrent NSCLC 4.
• The efficacy of nivolumab is not correlated with PD-L1 expression levels 4.
• Nivolumab combination therapy has been shown to be superior to nivolumab monotherapy 4.
• Treatment with nivolumab beyond progression is associated with improved survival in patients with NSCLC 5.
• Nivolumab has been found to be safe, with no significant increase in commonly reported adverse events, but it does enhance the risk of immune-related adverse events, such as pneumonitis 4.

Pharmacokinetics

• The pharmacokinetics of nivolumab have been found to be affected by gender, body surface area (BSA), and serum albumin 6.
• Women have been found to have 22% lower clearance of nivolumab compared to men, while a BSA greater than 2.2m2 and serum albumin less than 37.5g/L are associated with increased clearance 6.
• A clearance-response relationship has been observed in NSCLC, with higher clearance associated with progressive disease 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 has been found to be effective in both first-line and second-line treatment for NSCLC 4.
• Nivolumab may be beneficial for patients with NSCLC and progressive disease, with continued treatment beyond progression associated with improved survival 5.