Janssen's Subcutaneous Bispecific Antibody Talquetamab Approved in Korea for Relapsed/Refractory Multiple Myeloma

▎WuXi AppTec Content Team Report

July 2nd,Johnson & JohnsonA Korean company announced that itsBispecific AntibodyMedicinetalquetamabApproved for marketing in South Korea, with the indication ofMonotherapy for adult patients with relapsed or refractory multiple myelomaThese patients have received at least three prior treatments, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies.TalquetamabIt is an off-the-shelf, subcutaneously injectable, first-in-class bispecific antibody targeting GPRC5D and CD3., which had previously received accelerated approval from the U.S. FDA in August 2023.

Multiple Myeloma, often referred to as "elderly blood cancer," has seen an increase in incidence of over 60% in the past decade, with many patients experiencing relapses. In a cohort study, multiple myeloma patients who received three or more treatments, including anti-CD38 monoclonal antibodies, had an objective response rate (ORR) of only 30% or lower, resulting in a short life expectancy and poor prognosis.

Public information shows that talquetamabIt is a bispecific T-cell engager antibody that binds to the CD3 receptor expressed on the surface of T cells and to group 5 member D of the G protein-coupled receptor family C (GPRC5D).The latter is a novel target for multiple myeloma, highly expressed on the surface of multiple myeloma cells, non-malignant plasma cells, and some healthy tissues such as skin and tongue epithelial cells. Targeting GPRC5D has been shown to provide deep responses, and unlike many other targets in multiple myeloma, its expression is restricted to immune cells, offering an important new approach to targeting this heterogeneous disease.In addition, talquetamabFor once weekly (QW) or once every two weeks (Q2W) subcutaneous injection.

According to a press release from Johnson & Johnson, thisTalquetamab Approved in South KoreaBased on the MonumenTAL-1 study, which evaluatedtalquetamabEfficacy and safety of 0.4 mg/kg once weekly or 0.8 mg/kg every two weeks in patients who have failed or are refractory to three or more prior treatments. Based on the results of this study,Talquetamab has previously been approved for marketing by the FDA.

In the study, 143 patients received treatment at a dose of 0.4 mg/kg weekly.ORR was 74.1%, and the stringent complete response rate (sCR) was 24%.10% and 26% of patients achievedComplete Remission (CR) and Very Good Partial Remission (VGPR).145 patients received 0.8 mg/kg treatment every two weeks.ORR was 71.7%,sCR is30%，9% and 22% of patients achievedCR and VGPR。

It is worth mentioning that, in China,talquetamab（Taqiutumab) has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration in February 2024 and includedPriority Review, for the indication ofMonotherapy for patients who have previously received at least three treatmentsAdult patients with relapsed or refractory multiple myeloma。

[1]Janssen's bispecific antibody drug for multiple myeloma wins nod in Korea. Retrieved  July 2  , 2024,   from https://www.koreabiomed.com/news/articleView.html?idxno=24437