CHMP recommends Talvey to treat relapsed and refractory multiple myeloma (RRMM) in patients who have received at least three prior therapies
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation (CMA) for Talvey (talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) 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 subcutaneous bispecific antibody that binds G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target on multiple myeloma cells, and CD3, on T-cells.
The CHMP also recommended the approval of a Type II variation for teclistamab, providing a reduced, biweekly dosing schedule of 1.5mg/kg every other week in patients who have achieved a complete response or better for six months or longer. Teclistamab is the first bispecific antibody targeting B-cell maturation antigen (BCMA) on myeloma cells, and CD3 on T-cells to be licensed in Europe for the treatment of adult patients with RRMM who have had 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.
Despite recent advances, multiple myeloma remains a highly heterogenous and incurable disease that is unique to every patient. As the disease progresses and with each successive line of treatment, responses tend to decrease and patient outcomes become progressively worse. An unmet need remains for more therapeutic options with different modes of action, including for patients treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs through different cellular targets.
The CHMP recommendation for talquetamab is based on data from the Phase 1/II MonumenTAL-1 study (Phase 1: NCT03399799; Phase II: NCT04634552), evaluating the safety profile and efficacy of talquetamab in patients with RRMM. The latest data from the study were recently presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (2-6 June, Chicago) and the 2023 European Hematology Association (EHA) Hybrid Congress (8-11 June, Frankfurt).
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