Drug updated on 9/4/2024
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.
Latest News
Summary
- Yervoy (ipilimumab) is indicated 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; and for the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first-line treatment in combination with nivolumab.
- This summary is based on the review of 63 systematic review(s)/meta-analysis(es). [1-63]
- In advanced renal cell carcinoma (aRCC), pembrolizumab plus lenvatinib had a 57.1% chance of being the preferred treatment for progression-free survival (PFS), while pembrolizumab plus axitinib was considered the best for overall survival (OS) with a 40.2% probability.
- In metastatic uveal melanoma (mUM), the pooled overall response rate (ORR) was 9.2%, with 4.1% for anti-CTLA4, 7.1% for anti-PD(L)1, and 13.5% for anti-CTLA4 plus anti-PD1. The median OS for ipilimumab plus anti-PD1 was 16.0 months.
- In melanoma brain metastases (MBM), the combination of ipilimumab and nivolumab showed higher intracranial ORR and resulted in longer PFS and OS compared to control therapies.
- In non-small cell lung cancer (NSCLC), nivolumab plus ipilimumab demonstrated a 3-year OS of 50% in patients discontinuing treatment due to treatment-related adverse events (TRAEs).
- Ipilimumab is associated with a higher incidence of immune-related serious adverse events (irSAEs) compared to other immune checkpoint inhibitors (ICIs).
- Nivolumab plus ipilimumab in melanoma brain metastases (MBM) patients resulted in common grade 3/4 adverse events, including diarrhea or colitis (16%), hepatitis (15%), and rash (8%).
- Combination treatments involving ipilimumab, particularly in higher doses, showed increased rates of severe immune-related adverse events, including cutaneous immune-related adverse events (cirAEs) such as rash, pruritis, and vitiligo.
- Pembrolizumab plus axitinib demonstrated a lower incidence of overall adverse events compared to nivolumab plus ipilimumab, which had significantly higher toxicity, especially in older adults (≥75 years) and MBM patients.
- NSCLC: Nivolumab plus ipilimumab showed efficacy across different PD-L1 expression levels, with significant long-term survival benefits in patients with PD-L1 ≥ 1%, and differential outcomes based on histology, including both squamous and non-squamous subtypes.
- MBM: The combination of ipilimumab and nivolumab was particularly effective in treatment-naive and asymptomatic patients, highlighting better outcomes in these subgroups compared to others.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Yervoy (ipilimumab) Prescribing Information. | 2023 | Bristol-Myers Squibb Company, Princeton, NJ |