The European Commission (EC) has granted conditional marketing authorisation (CMA) for Janssen’s Talvey (talquetamab) as monotherapy for relapsed and refractory multiple myeloma (RRMM).
It is approved in adult patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Talquetamab is a bispecific T cell engaging antibody that binds to CD3, on the surface of T cells, and G protein-coupled receptor class C group 5 member D (GPRC5D), a target expressed on the surface of multiple myeloma cells and hard keratinised tissues.
“As multiple myeloma progresses and patients cycle through treatments, the disease becomes more difficult to treat and remission periods shorten,” said Maria-Victoria Mateos, Consultant Physician in Haematology, University Hospital of Salamanca. “Targeting GPRC5D has been shown to deliver deep responses, and unlike many other targets for multiple myeloma, its expression is limited on immune cells providing an important new approach to targeting this heterogenous disease.”
The CMA was supported by positive results from the Phase I/II MonumenTAL-1 study), in which 60.8% of patients on the 0.8mg/kg dose achieved a very good partial response or better and 38.7% achieved a complete response or better. An estimated 76.3% and 51.5% of patients maintained a response for at least nine months at the 0.8mg/kg and 0.4mg/kg doses, respectively.
The most common adverse event (AEs) observed in the study was cytokine release syndrome (77%, 1.5% Grade 3 or 4).
The EC approval follows the US Food and Drug Administration (FDA) approval of talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, in August 2023.
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World