EPKINLY

What it is

Epcoritamab is a humanised bispecific antibody that specifically binds to CD3+ T cells and CD20+ B cells. EPKINLY is available as a 4 mg/0.8 mL concentrate solution for injection and a 48 mg/0.8 mL solution for injection. EPKINLY is for subcutaneous injection only.

Approved indications

— Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Dosing overview

The EPKINLY dosing schedule includes an initial priming dose of 0.16 mg on Cycle 1 Day 1, an intermediate dose of 0.8 mg on Cycle 1 Day 8, and a full dose of 48 mg administered from Cycle 1 Day 15 and onwards, according to a 28-day cycle schedule. In Cycle 1, the 48 mg full dose is given on Days 15 and 22; in Cycles 2–3, 48 mg is given on Days 1, 8, 15, and 22; in Cycles 4–9, 48 mg is given on Days 1 and 15; and in Cycles 10 and beyond, 48 mg is given on Day 1. EPKINLY is administered until disease progression or unacceptable toxicity.

Key safety warnings

Cytokine release syndrome (CRS) and neurological toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), can occur in patients receiving EPKINLY and may be serious and life-threatening. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia, with a median time to onset of 2 days from the most recent dose and 20.6 hours after the first full dose, with most CRS events occurring in Cycle 1 and associated with the first full dose. Following administration of the first full dose, patients should remain within close proximity to a healthcare facility that can assess and manage potential CRS and/or ICANS for at least 24 hours. ICANS, including fatal cases, have occurred in patients receiving epcoritamab and may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema, with a median time to onset of 16.5 days from the start of treatment. At the first signs or symptoms of ICANS, institute treatment with corticosteroids and non-sedating anti-seizure medications as appropriate. Treatment with EPKINLY may lead to an increased risk of infections, and serious infections, including fatal infections, were observed in patients treated with epcoritamab in clinical trials. Avoid administration of EPKINLY in patients with clinically significant active systemic infections. Tumour lysis syndrome (TLS) has been reported in patients receiving epcoritamab, and patients at increased risk are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent, with monitoring especially for patients with high tumour burden or rapidly proliferative tumours.

Contraindications

Hypersensitivity to epcoritamab, or to any of the excipients listed in the product information.

PBS listing

EPKINLY is listed on the PBS in two presentations: a 48 mg/0.8 mL solution for subcutaneous injection (4 items, authority required and streamlined restriction, ex-manufacturer price A$9230.77) and a 4 mg/0.8 mL concentrate solution for subcutaneous injection (2 items, authority required restriction, ex-manufacturer price A$769.23). The PBAC recommended the 48 mg strength for the treatment of relapsed or refractory DLBCL in November 2024 under Section 100 (Efficient Funding of Chemotherapy Program) with authority required streamlined listing.

Regulatory history

EPKINLY (epcoritamab 48 mg/0.8 mL and 4 mg/0.8 mL solutions for injection) was registered on the ARTG on 6 January 2025. The medicine has provisional approval in Australia for the treatment of adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy, based on overall response and duration of response from an uncontrolled, open-label Phase I/II study, with continued approval dependent on verification and description of benefit in confirmatory trials. In November 2024, the PBAC recommended EPKINLY for listing with a finding of significant improvement in efficacy over rituximab + gemcitabine + oxaliplatin, subject to price reduction and a risk-sharing arrangement.