MonumenTAL-1: Outcomes From the Extended Median Follow-Up Data (Part 2)
Panelists discuss how the extended median follow-up data from the MonumenTAL-1 trial demonstrate that Q2 weekly dosing of talquetamab shows superior progression-free survival (11.2 vs 7.5 months), duration of response (19.5 vs 7.5 months), and overall survival compared with weekly dosing, with particularly encouraging efficacy in high-risk cytogenetics and older patients while maintaining a manageable safety profile.
MonumenTAL-1 Outcomes and Extended Median Follow-Up Data
The MonumenTAL-1 trial’s extended follow-up data, presented at a recent meeting, provides crucial insights into long-term outcomes for BCMA-targeted therapy with median follow-up ranging from 30 to 38 months across different cohorts. The study examined 3 main dosing cohorts: weekly dosing, every-2-week (Q2W) dosing, and a prior T-cell redirecting therapy cohort. Overall response rates remained consistent in the mid-60s to mid-70s range, with no significant new findings in terms of efficacy rates compared with earlier data presentations.
The most notable finding from this extended follow-up concerns the superior outcomes with Q2W dosing compared with weekly administration. The Q2W arm demonstrated significantly improved progression-free survival (11.2 months vs 7.5 months), nearly doubled median duration of response (19.5 months vs 7.5 months), and better overall survival outcomes. The 3-year overall survival rates showed 61% for Q2W dosing compared with 49% for weekly dosing, with median overall survival not yet reached for the Q2W cohort vs 34 months for weekly dosing.
Subgroup analyses revealed particularly encouraging results for traditionally challenging patient populations, including high-risk cytogenetics and older patients, where this agent demonstrated effectiveness comparable to or better than standard-risk patients. The safety profile remained consistent with previous reports, showing grade 3 or higher infection rates in the low-to-mid 20% range, which compares favorably with BCMA-targeted therapies. Movement-related disorders were noted as rare occurrences. The low discontinuation rate of 2.5% across cohorts supports the tolerability profile, making this an attractive option for older and high-risk patients who often have limited treatment alternatives.
