TALVEY

What it is

TALVEY (talquetamab) is a humanised immunoglobulin G4-proline, alanine, alanine (IgG4-PAA)-based bispecific antibody directed against G Protein-coupled receptor family C group 5 member D (GPRC5D) and the cluster of differentiation 3 (CD3) receptors. TALVEY is a colourless to light yellow preservative-free solution for injection. TALVEY is available in two presentations: a vial containing 3 mg of talquetamab (2 mg per mL) and a vial containing 40 mg of talquetamab (40 mg per mL).

Approved indications

— Adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Dosing overview

TALVEY is administered via subcutaneous injection. TALVEY is administered subcutaneously on a weekly or biweekly (every 2 weeks) dosing schedule. For weekly dosing, patients receive step-up doses of 0.01 mg/kg on day 1, 0.06 mg/kg on day 3, then 0.4 mg/kg as the first treatment dose one week later and weekly thereafter. For biweekly dosing, patients receive step-up doses of 0.01 mg/kg on day 1, 0.06 mg/kg on day 3, and 0.4 mg/kg on day 7, then 0.8 mg/kg as the first treatment dose two weeks later and every 2 weeks thereafter. Treatment continues until disease progression or unacceptable toxicity.

Key safety warnings

Cytokine release syndrome (CRS) and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), can occur in patients receiving TALVEY. Clinical signs and symptoms of CRS may include pyrexia, hypotension, chills, hypoxia, headache, and tachycardia. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Patients must remain within proximity of a healthcare facility and be monitored for 48 hours after administration of all doses within the TALVEY step-up phase for signs and symptoms of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Serious or life-threatening neurologic toxicities, including ICANS, have occurred following treatment with TALVEY. ICANS, including fatal reactions, have occurred following treatment with TALVEY. Clinical signs and symptoms of ICANS may include confusional state, depressed level of consciousness, disorientation, somnolence, lethargy and bradyphrenia. Oral toxicities, including dysgeusia, dry mouth, dysphagia, and stomatitis, may occur following treatment with TALVEY. Seventy-eight percent (78%) of patients had Grade 1 or 2 events, with Grade 3 events occurring in 2% of patients. Serious infections, including life-threatening or fatal infections, have been reported in patients receiving TALVEY. Treatment-emergent Grade 3 or 4 neutropenia and thrombocytopenia have been observed in patients who received TALVEY. A majority of events occurred during the first 8 to 10 weeks.

Contraindications

TALVEY is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

Regulatory history

TALVEY talquetamab 2 mg/mL and 40 mg/mL solutions for injection were first listed on the ARTG on 2024-09-26. TALVEY received approval on 2024-09-24 as monotherapy with provisional approval for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The decision to approve this indication was made on the basis of the overall response rate in a single arm study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials. This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information.