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Update From Phase II MonumenTAL-1 Study of Talquetamab in Resistant Myeloma

By: Joshua D. Madera, MD
Posted: Wednesday, July 5, 2023

Consistent with the phase I findings of the MonumenTAL-1 study, the phase II analyses have revealed improved clinical outcomes and increased response rates in patients with relapsed or refractory multiple myeloma treated with talquetamab—a GPRC5D x CD3 bispecific antibody—according to a presentation given at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8036). In addition, treatment with talquetamab yielded “high” response rates in patients with prior T-cell redirection therapy, stated Carolina D. Schinke, MD, of the University of Arkansas for Medical Sciences, Little Rock, and colleagues.

A total of 339 patients with relapsed or refractory multiple myeloma were recruited for the study. Patients were randomly assigned to receive 0.4 mg/kg of talquetamab weekly (n = 143) or 0.8 mg/kg of talquetamab biweekly (n = 145) with step-up doses. The remaining 51 patients had previously received T-cell redirection therapy and were randomly assigned to receive either of the aforementioned regimens.

The overall response rate to treatment with talquetamab was 74%, 73%, and 63% for the once- and twice-weekly talquetamab-treated groups and the T-cell redirection therapy groups, respectively. These observed rates were also consistent across all treatment subgroups. Furthermore, the median progression-free survival was 7.5 months in the once-weekly talquetamab cohort, 11.9 months in the twice-weekly talquetamab cohort, and 5.1 months in the T-cell redirection therapy cohort, according to the investigators.

Moreover, treatment-related adverse events included cytokine-release syndrome (79% for once-weekly talquetamab vs. 75% for twice-weekly talquetamab vs. 77% for T-cell redirection therapy), dysgeusia (50% vs. 48% vs. 61%), nail-related conditions (54% vs. 53% vs. 61%), and skin-related conditions (56% vs. 71% vs. 69%). Rates of infection were 58%, 65%, and 71% with reduced rates of opportunistic infections, respectively.

Disclosure: For full disclosures of the study authors, visit

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