Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 40 mg/4 mL, [10 mg/mL], 100 mg/10 mL, [10 mg/mL], 120 mg/12 mL [10 mg/mL], 240 mg/24 mL [10 mg/mL]) |
| Drug Class | Human programmed death receptor-1 (PD-1) blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma as a single agent or in combination with ipilimumab
- Indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma
- Indicated for the treatment of adult patients with resectable (tumors 4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy
- Indicated for the treatment of Non-Small Cell Lung Cancer (NSCLC) in adult patients expressing PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab
- Indicated for the treatment of metastatic or recurrent non-small cell lung cancer in adult patients with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy
- Indicated for the treatment of adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy
- Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO
- Indicated for the treatment of unresectable malignant pleural mesothelioma in adult patients, as first-line treatment in combination with ipilimumab
- Indicated for use as a first-line treatment in combination with ipilimumab in adult patients with intermediate or poor risk advanced renal cell carcinoma
- Indicated for use as a first-line treatment in combination with cabozantinib in adult patients with advanced renal cell carcinoma
- Indicated for the treatment of adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
- Indicated for the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after an autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT
- Indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
- Indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC
- Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- Indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab
- Indicated for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib, as a single agent or in combination with ipilimumab
- Indicated for the treatment ofadult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy
- Indicated for the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum containing chemotherapy
- Indicated for the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab
- Indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy
- Indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.
Latest News
Summary
- This summary is based on the review of 132 systematic review(s)/meta-analysis(es). [1-132]
- Progression-Free Survival (PFS): Nivolumab combined with Ipilimumab demonstrated a notable improvement in PFS, especially in the microsatellite instability (MSI) subgroup of metastatic colorectal cancer (mCRC) (hazard ratio (HR) =0.21; 95% confidence interval (CI), 0.13-0.34). For the microsatellite-stable (MSS) subgroup, Nivolumab with standard of care (SOC) showed moderate PFS improvement (HR=0.74; 95% CI, 0.53-1.02), and Atezolizumab with SOC showed efficacy in second-line therapy (HR=0.66; 95% CI, 0.44-0.99).
- Overall Survival (OS): In advanced urothelial carcinoma (aUC), Nivolumab combined with platinum-based chemotherapy showed significant OS improvement compared to other therapies, such as Pembrolizumab combined with platinum chemotherapy (HR=0.60; 95% CI: 0.45-0.81). Similarly, the combination of Pembrolizumab and Enfortumab Vedotin (PEM+EV) demonstrated a significant OS advantage in aUC (HR=0.55; 95% CI: 0.42-0.72).
- Objective Response Rate (ORR): In aUC, Pembrolizumab with Enfortumab Vedotin (PEM+EV) significantly improved ORR compared to other treatments (odds ratio (OR)=2.63; 95% CI: 2.00-3.45), reflecting enhanced response rates.
- Disease Control Rate (DCR): Nivolumab was associated with improved DCR in hepatocellular carcinoma (HCC) studies compared to regorafenib, though results varied in statistical significance across studies.
- Grade 3 or Higher Adverse Events (AEs): The incidence of severe adverse events was notably elevated in combination therapies, particularly Nivolumab + Ipilimumab, with a relative risk (RR) of 1.52 (95% CI: 1.30 to 1.78) compared to Nivolumab alone.
- Immune-Related AEs: Immune-related AEs, such as colitis and skin reactions, were more common in combination therapies like anti-cytotoxic T lymphocyte antigen-4 (CTLA-4) and anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) agents. Endocrinopathies were also more frequent with Pembrolizumab and Nivolumab, including hypothyroidism and hyperthyroidism.
- Hepatotoxicity in Comorbid Populations: Higher hepatotoxicity rates were observed with combination therapies involving Nivolumab in patients with hepatitis B or C, underscoring the need for careful liver monitoring and consideration of antiviral prophylaxis during treatment.
- Comparative Safety in aUC: The PEM+EV combination had fewer grade 3 or higher AEs than other treatments in aUC, suggesting a more favorable safety profile in this patient population.
- PD-L1 Expression and Comorbid Hepatitis: High PD-L1 expression (e.g., combined positive score (CPS) ≥10) was associated with improved outcomes for Pembrolizumab combined with chemotherapy across multiple studies, while patients with hepatitis B or C treated with Nivolumab showed an increased risk of hepatitis-related adverse events, necessitating close monitoring and possible antiviral prophylaxis.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Opdivo (nivolumab) Prescribing Information. | 2024 | Bristol-Myers Squibb Company, Princeton, NJ |