Recommended Phase II Doses of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma From MonumenTAL-1: Clinical Pharmacology Results.
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Journal:
Clinical pharmacology and therapeutics
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Published:
July 24, 2025
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Authors:
['Gong J', 'Zhou J', 'Yuan D', 'Ma X', 'Vishwamitra D', 'Hilder B', 'Masterson TJ', 'Tolbert J', 'Renaud T', 'Heuck C', 'Kane C', 'Samtani MN', 'Girgis S', 'Haddish-Berhane N', 'Berdeja J', 'Krishnan A', 'Ouellet D.']
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Category:
Immunology
Talquetamab, the first GPRC5D × CD3 bispecific antibody, shows remarkable 66% response rates in relapsed/refractory multiple myeloma patients. Its optimal dosing regimen balances efficacy and safety, paving the way for a promising new treatment option.
This study characterized the pharmacokinetics, pharmacodynamics, immunogenicity, and exposure-response relationships of talquetamab in patients with relapsed/refractory multiple myeloma. The findings support the recommended phase II doses of 0.4 mg/kg weekly and 0.8 mg/kg every other week, which demonstrated high overall response rates with manageable safety profiles. The study's significance lies in its comprehensive evaluation of talquetamab's clinical pharmacology, guiding the optimal use of this novel bispecific antibody. Limitations include the need for further investigation in larger patient populations and the potential impact of myeloma subtype and disease stage on talquetamab exposure.