WINGLORE

What it is

Winglore (ipilimumab) is a recombinant, fully human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). Winglore is a sterile, preservative-free liquid for intravenous administration, which may contain a small amount of visible translucent-to-white, amorphous ipilimumab particulates.

Approved indications

— Unresectable or metastatic melanoma, as monotherapy. — Unresectable or metastatic melanoma, in combination with nivolumab. — Intermediate or poor-risk, previously untreated advanced renal cell carcinoma, in combination with nivolumab. — First-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumour aberrations, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy. — First-line treatment of unresectable malignant pleural mesothelioma, in combination with nivolumab. — First-line treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%, in combination with nivolumab. — Unresectable or metastatic colorectal cancer that is microsatellite instability high or mismatch repair deficient, in combination with nivolumab. — First-line treatment of unresectable or metastatic hepatocellular carcinoma, in combination with nivolumab.

Dosing overview

**Monotherapy (unresectable or metastatic melanoma):** The recommended dose is 3 mg/kg administered intravenously over 30 minutes every 3 weeks for a total of 4 doses (induction therapy). Additional treatment with 4 doses may be considered for patients who develop progressive disease after prior complete or partial response or after stable disease lasting longer than 3 months, administered at 3 mg/kg intravenously over 30 minutes every 3 weeks.

Key safety warnings

Winglore can cause severe and life-threatening immune-related adverse reactions. These reactions are seen more frequently and are more severe with Winglore and nivolumab combination therapy than with either agent alone. Immune-related adverse reactions can involve any organ system. The majority of immune-related adverse reactions initially manifest during treatment; however, some can occur weeks to months after discontinuation. Some immune-related adverse reactions can be permanent, such as thyroid dysfunction and diabetes mellitus. Life-threatening or fatal immune-related adverse reactions that have occurred include colitis, intestinal perforation, hepatitis, pneumonitis, hypophysitis, adrenal insufficiency, toxic epidermal necrolysis, myocarditis, encephalitis, myasthenia gravis and neuropathy. Monitoring at least prior to each dose is recommended. Patients should be advised of the importance of immediately reporting symptoms. Winglore monotherapy and Winglore in combination with nivolumab therapy should be administered and monitored under the supervision of physicians experienced in the treatment of cancer. Dose reduction is not recommended.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Regulatory history

Winglore (ipilimumab) was approved by the TGA on 27 June 2011 as monotherapy for the treatment of patients with unresectable or metastatic melanoma who have failed or are intolerant to prior therapy. The two strengths were first listed on the ARTG on 4 July 2011: the 50 mg in 10 mL vial and the 200 mg in 40 mL vial (both 5 mg/mL concentrate solutions for intravenous infusion).