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Talquetamab for patients with RRMM: Updated results from the MonumenTAL-1 trial
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The phase I/II MonumenTAL-1 trial (NCT03399799, NCT04634552) assessed the safety and efficacy of talquetamab, a GPRC5D/CD3-targeted bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM).1 Results from this trial, which were previously reported by the Multiple Myeloma Hub, led to the approval of talquetamab by the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of patients with RRMM who have received ≥4 or ≥3 lines of therapy, respectively. Updated efficacy and safety results from three cohorts of patients from the MonumenTAL-1 trial – 0.4 mg/kg weekly (QW), 0.8 mg/kg biweekly (Q2W), and patients with prior T-cell redirected therapy (TCR) – with a longer median follow-up and including additional patients were presented at the European Hematology Association (EHA) 2024 Hybrid Congress by Rasche.1 |
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With a longer follow-up, the overall response rates in MonumenTAL-1 were 74%, 70%, and 67% in the QW, Q2W, and prior TCR cohorts, respectively. |
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Patients continued to experience durable responses, particularly patients with a complete response or better (≥CR); in the QW and Q2W cohorts, the median durations of response were 9.5 months and 17.5 months, respectively, and 28.6 months and not reached, respectively, among patients with ≥CR. |
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The median progression-free survival was 7.5 months, 11.2 months, and 7.7 months, and the 24-month overall survival rates were 60.6%, 67.1%, and 57.3% in the QW, Q2W, and prior TCR cohorts, respectively. |
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The safety profile of talquetamab was consistent with previous results, with no new safety signals observed. |
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These findings support the use of talquetamab for the treatment of patients with RRMM. |
- Rasche L. Long-term efficacy and safety results from the phase 1/2 MonumenTAL-1 study of talquetamab, a GPRC5D×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. Poster #P915. Presented at: European Hematology Association 2024 Hybrid Congress; Jun 13–16, 2024; Madrid, ES.
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