Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 5 mg/mL) |
| Drug Class | Cytotoxic T-lymphocyte antigen 4-blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab.
- For the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
- For the treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab.
- For the treatment of adult and pediatric patients 12 years and older 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, in combination with nivolumab.
- For the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib, in combination with nivolumab.
- For the treatment of adult patients with metastatic non-small cell lung cancer 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 nivolumab.
- For the treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy.
- For the treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab.
- For the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab.
Summary
- Ipilimumab (Yervoy) is primarily employed in conjunction with other immune checkpoint inhibitors like nivolumab for various advanced or metastatic cancers, including melanoma, renal cell carcinoma, colorectal cancer, non-small cell lung cancer (NSCLC), hepatocellular carcinoma, and pleural mesothelioma.
- A total of 62 studies were reviewed to gather information about the drug's safety and effectiveness across different indications and combinations.
- When combined with nivolumab, ipilimumab shows increased efficacy in terms of overall survival (OS) and progression-free survival (PFS) across multiple cancers. However, this combination also leads to a higher incidence of adverse events compared to monotherapy or other combinations.
- Patients with high PD-L1 expression (>1%) showed better outcomes when treated with ipilimumab in combination therapies for NSCLC and melanoma.
- In cases of melanoma brain metastases, treatment-naive patients show promising results when treated using a regimen that combines ipilimumab with nivolumab.
- For advanced renal cell carcinoma patients, especially those having intermediate or poor risk factors, lenvatinib has shown more favorable results than Yervoy's combination therapy.
- Compared to other drugs such as pembrolizumab, which offers competitive efficacy particularly in NSCLC but comes along with different safety profiles; nivolumab combined with ipilimumab typically provides a superior balance between efficacy (in terms of ORR, PFS, and OS) and safety (AEs).
- The use of the combo therapy involving both ipilimumab (Yervoy) and nivolumab, while effective, is associated with a high burden of Grade 3/4 AEs, making it crucial to manage patient care effectively.
- The incidence and severity of immune-related adverse events (irAEs) are pivotal considerations, especially in elderly populations and those with specific underlying conditions.
- Safety profiles varied significantly across different cancer types, dosages, and combination regimens, implying the need for personalized treatment approaches and careful monitoring.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Yervoy (ipilimumab) Prescribing Information. | 2023 | Bristol-Myers Squibb Company, Princeton, NJ |