Johnson & Johnson (J&J) announced that Talvey (talquetamab-tgvs) has shown long-term efficacy and durability in patients with relapsed or refractory multiple myeloma (RRMM).
The US drugmaker unveiled positive data from the Phase 1/2 MonumenTAL-1 trial.
In the study, Talvey was effective and durable when used before or after CAR-T therapy or bispecific antibody therapies in triple-class-exposed patients with RRMM.
Patients treated with the drug maintained high overall response rates (ORR) and durable responses with 20 to 30 months of median follow-up, regardless of prior T-cell therapy.
Talvey is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D).
GPRC5D is a novel multiple myeloma target, highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, along with some healthy tissues.
Johnson & Johnson Innovative Medicine multiple myeloma disease area leader vice president Jordan Schecter said: “With multiple dosing options and the ability to be used both before or after CAR-T therapy and BCMA bispecifics, TALVEY is an important and versatile treatment option for the treatment of relapsed or refractory multiple myeloma.
“The low rate of grade 3/4 infections seen in MonumenTAL-2 suggests the flexibility of TALVEY as a combination partner with an immunomodulatory agent for patients who continue to face limited treatment options with this complex hematologic disease.”
The MonumenTAL-1 study enrolled 297 patients with no prior exposure to T-cell redirection therapy and received Talvey at the Phase 2 dose of 0.8 mg/kg biweekly or 0.4 mg/kg weekly.
Patients in the Q2W cohort showed a median duration of response (DOR) of 17.5 months at a median follow-up of 23.4 months, with median DOR not reached in patients with complete response (CR) or better.
The QW arm showed a median DOR of 9.5 months a median follow-up of 29.8 months, with a median DOR of 28.6 months in patients with CR or better.
After 24 months, 67.1% of patients were alive from Q2W and 60.6% QW dosing cohorts, respectively.
Talvey continued to show strong efficacy, with 55.1% of patients achieving a very good partial response (VGPR) or better and 57.3% alive at 24.2 months, at a median follow-up of 20.5 months.
The drug resulted in infection rates that remained lower than in studies of B-cell maturation antigen–targeted bispecific antibodies (BsAbs), consistent with previous reports.
In August last year, Talvey received FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
The drug also secured the European Commission (EC) conditional marketing authorisation (CMA) for the treatment of adult patients with (RRMM) who have received prior therapies.
