talquetamab Clinical Evidence: MONUMENTAL-1 to Real-World Data
Panelists discuss how talquetamab demonstrates impressive clinical efficacy with approximately 70% response rates in the pivotal MONUMENTAL-1 trial, including patients previously treated with other immunotherapies, and how real-world data from studies like Real Italy corroborate these trial results with similar 67% response rates across diverse patient populations including high-risk subgroups.
EP: 1.Karen's Story: Navigating Multiple Myeloma Treatment Lines
EP: 2.Understanding Bispecific Mechanisms and Dual Targeting in Multiple Myeloma: Why talquetamab for This Patient Journey
EP: 3.talquetamab Clinical Evidence: MONUMENTAL-1 to Real-World Data
EP: 4.Between Real-World Decisions: Selecting GPRC5D vs BCMA-Targeting Bispecific
Clinical Trial Foundation and Efficacy
The approval of talquetamab was based on the pivotal MONUMENTAL-1 study, which demonstrated impressive efficacy in heavily pretreated multiple myeloma patients. The trial tested 2 different dosing regimens: 0.8 mg every other week and 0.4 mg once weekly. Remarkably, approximately 70% of patients responded to treatment, including those who had previously received other immunotherapies such as BCMA-targeted CAR-T cell therapy or BCMA bispecific antibodies. The responses proved durable, with median response duration reaching 17 months and progression-free survival extending to about 10 months. Patients achieving deeper responses, such as complete responses, experienced even longer durations of benefit, suggesting that the depth of response correlates with treatment durability.
Real-World Validation
Following regulatory approval, real-world studies have validated the clinical trial results, confirming that talquetamab's effectiveness translates beyond controlled trial settings. The Real Italy study, analyzing data from nearly 100 patients treated in clinical practice, demonstrated a response rate of approximately 67%, closely matching the clinical trial outcomes. This consistency between trial and real-world data provides reassurance that the treatment benefits observed in controlled settings are reproducible in everyday clinical practice across diverse patient populations and treatment centers.
Efficacy Across Patient Subgroups
Importantly, talquetamab has shown effectiveness across various patient subgroups, including those with high-risk genomic features and patients refractory to multiple treatment lines —populations that are traditionally difficult to treat. In high-risk patient cohorts, the overall response rate remained substantial at approximately 50%, demonstrating the drug's broad applicability. Indirect comparisons with other available treatments suggest talquetamab's superiority in terms of both efficacy and progression-free survival, making it a valuable option across different patient risk categories rather than being limited to favorable patient populations.
