The FDA approval was based on results from the talquetamab Phase 2 MonumenTAL-1 study in which Talvey showed meaningful overall response rates of more than 70% with durable responses
Janssen gets FDA approval for Talvey. (Credit: Vysotsky (Wikimedia))
The Janssen Pharmaceutical Companies of Johnson & Johnson has secured the US Food and Drug Administration (FDA) approval for Talvey (talquetamab-tgvs) to treat patients with heavily pretreated multiple myeloma (MM).
Talvey is a first-in-class bispecific T-cell engaging antibody. It sticks to the CD3 receptor found on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells.
FDA has approved Talvey for adult patients with relapsed or refractory MM who were administered with at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
The MonumenTAL-1 study enrolled 300 patients to assess the safety and efficacy of Talvey in adults with multiple myeloma at the recommended Phase 2 dose(s), established at SC 0.4 mg/kg weekly and 0.8 mg/kg every two weeks, respectively.
The approval was based on results from the talquetamab Phase 2 MonumenTAL-1 study in which Talvey showed meaningful overall response rates (ORR).
At the SC biweekly dose of 0.8 mg/kg, 73.6% of patients achieved an ORR.
A very good partial response (VGPR) or better was attained by 58% of patients with a median follow-up of approximately six months among responders, with a complete response (CR) or better attained by 33% of patients.
Additionally, 73.1% of patients experienced an ORR at the SC weekly dose of 0.4 mg/kg.
A VGPR or better was attained by 57% of patients with a median follow-up of around 14 months after the first response among responders, with a CR or better being attained by 35% of patients.
Janssen Research & Development Oncology Global Therapeutic Area head Peter Lebowitz said: “The approval of Talvey, our fifth innovative therapy and second bispecific antibody approved for the treatment of multiple myeloma, demonstrates our commitment to expanding our portfolio of medicines to help address unmet needs for patients who continue to face challenges with this complex hematologic malignancy.”
MonumenTAL-1 is a Phase 1/2 single-arm, open-label, multicohort, multicentre dose-escalation study.
Its efficacy was based on ORR and duration of response (DOR) as assessed by an Independent Review Committee using IMWG criteria.