|Date of Abstract presentation
|11th December 2023
TALVEY (talquetamab) is a bispecific T-cell engaging antibody designed to target the CD3 receptor found on T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D). The findings presented at the ASH 2023, from the first-ever study of a regimen combining a GPRC5D-targeted therapy and an immunomodulatory agent revealed that, in the Phase Ib MonumenTAL-2 trial, a group of 35 patients received treatment with subcutaneous TALVEY. Among them, 19 were administered TALVEY at a recommended dose of 0.8 mg/kg Q2W or 0.4 mg/kg QW with step-up doses, plus two milligrams of oral pomalidomide daily. After a median follow-up of 15 months for the QW cohort, an impressive 94% overall response rate (ORR) was observed in evaluable patients, with 63% achieving a complete response (CR) or better. Notably, 88% of responders attained a very good partial response (VGPR) or higher. In the Q2W cohort, with a median follow-up of 11.1 months, the ORR remained robust at 84% in evaluable patients. Around 37% achieved a CR or better, and 68% achieved a VGPR or better. These compelling results were consistent across diverse patient subgroups, including those who had received prior treatment with pomalidomide or CAR-T cell therapy. Apart from that, the responses in both patient cohorts were rapid, with a median time to first response of 1.7 months in the QW cohort and 1.2 months in the Q2W cohort. The efficacy outcomes from the Phase Ib MonumenTAL-2 trial, investigating TALVEY in conjunction with pomalidomide for patients with R/R MM, underscore the promising prospect of integrating TALVEY with additional anti-myeloma treatments.
In terms of safety outcomes, the most common grade 3/4 hematologic adverse events (AEs) were neutropenia (54%), anemia (26%), and thrombocytopenia (20%). Moreover, the adverse events led to TALVEY dose reduction or schedule change in 34% of patients and dose reduction of pomalidomide in 46% of patients. Furthermore, treatment discontinuation was reported for four patients, and unfortunately, one patient succumbed due to pulmonary embolism.
“Findings from the MonumenTAL-2 demonstrate the versatility of TALVEY across patient subgroups, showing the efficacy, manageable safety profile, and effect of TALVEY on B-cell preservation –Expert Opinion.
The outcomes from the MonumenTAL-2 study underscore TALVEY’s adaptability in R/R MM patients, affirming its effectiveness, well-tolerated safety profile, and impact on B-cell preservation. The encouraging initial findings with the TALVEY and pomalidomide combination, particularly in patients with prior exposure to pomalidomide or CAR-T cell therapy, reaffirm strategic commitment to enhancing and intensifying treatment responses through innovative combination regimens. This not only demonstrates the therapeutic potential of TALVEY but also emphasizes the dedication to advancing scientific approaches for improved outcomes in multiple myeloma.
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