Ipilimumab (Yervoy)

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General information

Class/mechanism: Anti-CTLA-4 antibody. CTLA-4 is a negative regulator of T-cell activation and ipilimumab interferes with the ability of CTLA-4 to interact with its ligands CD80/CD86. CTLA-4 blockade results in T-cell activation and proliferation, and it is suspected that its anti-neoplastic activity may be due to T-cell mediated anti-tumor immune responses.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Toxicity management

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Colorectal cancer

Hepatocellular carcinoma

  • 2020-03-10: Accelerated approval in combination with nivolumab for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. (Based on CheckMate 040combo)

Melanoma

  • 2011-03-25: FDA approved for the treatment of unresectable or metastatic melanoma. (Initial approval; based on MDX010-20)
  • 2015-10-28: FDA approved for adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (Approval extended to adjuvant setting; based on EORTC 18071)

Malignant pleural mesothelioma

Non-small cell lung cancer

  • 2020-05-15: Approved in combination with nivolumab as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1 (at least 1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (New disease entity; based on CheckMate 227)
  • 2020-05-26: Approved in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (PD-L1 expression requirement removed when given with chemotherapy; based on CheckMate 9LA)

Renal cell carcinoma

History of changes in EMA indication

  • 2011-07-13: Initial marketing authorization as Yervoy. Yervoy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. (Based on MDX010-20)
  • 2013-10-31: Extension of indication of Yervoy for the treatment of previously untreated adult patients with advanced (unresectable or metastatic) melanoma.
  • 2018-01-18: Extension of indication to include the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
  • 2018-05-31: Extension of indication to include the treatment of advanced (unresectable or metastatic) melanoma in adults in combination with nivolumab for Yervoy.
  • 2019-01-11: Extension of indication to include the combination treatment with nivolumab and ipilimumab of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
  • 2020-11-05: Extension of indication to include first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation for combination of OPDIVO/Yervoy and chemotherapy.
  • 2021-06-01: Extension of indication to include first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) for combination treatment of Opdivo and Yervoy.
  • 2021-06-24: Extension of indication to include the combination of nivolumab with ipilimumab in the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine based combination chemotherapy.
  • 2022-04-01: Extension of indication to include first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PD-L1 expression at least 1% for Opdivo in combination with Yervoy.
  • 2023-05-23: Extension of indication to include in combination with nivolumab the treatment of adolescents (12 years of age and older) for advanced (unresectable or metastatic) melanoma. (Based on NCI-2014-01222)

History of changes in Health Canada indication

Colorectal cancer

  • 2022-03-03: New indication in combination with nivolumab for Microsatellite Instability-High (MSI-H)/ Mismatch Repair Deficient (dMMR) Metastatic colorectal cancer.

Melanoma

  • 2012-02-01: Initial notice of compliance for the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease.
  • 2014-09-10: Revised indication for the treatment of unresectable or metastatic melanoma.
  • 2017-04-13: New indication in combination with Opdivo (nivolumab) for the treatment of unresectable or metastatic melanoma in previously untreated adults.
  • 2022-03-03: New reduction of indication for Unresectable or Metastatic Melanoma (unclear details).

Malignant pleural mesothelioma

Renal cell carcinoma

  • 2018-12-04: New indication in combination with Opdivo (nivolumab) for the treatment of adult patients with intermediate/poor-risk advanced or metastatic renal cell carcinoma.

Non-small cell lung cancer

History of changes in PMDA indication

Colorectal cancer

  • 2020-09-25: New indication for the treatment of unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer that has progressed after cancer chemotherapy.

Esophageal cancer

  • 2022-05-26: New indication and a new dosage for the treatment of unresectable advanced or recurrent esophageal cancer.

Malignant pleural mesothelioma

Melanoma

  • 2015-07-03: Initial approval for the treatment of unresectable melanoma.

Non-small cell lung cancer

Renal cell carcinoma

  • 2018-08-21: New indication and a new dosage for the treatment of unresectable or metastatic renal cell carcinoma.

Also known as

  • Code names: BMS-734016, MDX-010
  • Brand name: Yervoy

References

  1. ↑ 1.0 1.1 1.2 Ipilimumab (Yervoy) package insert
  2. ↑ Ipilimumab (Yervoy) package insert (locally hosted backup)
  3. ↑ Yervoy manufacturer's website
  4. ↑ YERVOY Risk Evaluation and Mitigation Strategy (REMS) Site
  5. ↑ Ipilimumab (Yervoy) patient drug information (Chemocare)
  6. ↑ Ipilimumab (Yervoy) patient drug information (UpToDate)
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