Dr Schinke on the Rationale for the MonumenTAL-1 Trial in Multiple Myeloma

Carolina D. Schinke, MD, associate professor, medicine, Myeloma Center, University of Arkansas for Medical Sciences, discusses the rationale for conducting the phase 1/2 MonumenTAL-1 trial (NCT04634552) in patients with multiple myeloma.

Patients who have received several previous treatments for relapsed/refractory multiple myeloma have an unmet need that should be addressed, Schinke begins, stating that few treatment options exist for this population. In response to this unmet need, investigators launched the phase 1/2 MonumenTAL-1 trial of talquetamab-tgvs (Talvey), a GPRC5DxCD3 bispecific antibody, in patients with relapsed/refractory disease. At the 2023 ASCO Annual Meeting, investigators shared data from the trial. Talquetamab is a novel immunotherapy that is part of a new class of bispecific antibodies, Schinke says. Notably, novel immunotherapies are gaining traction in multiple myeloma, especially in relapsed/refractory disease, she explains.

Moreover, prior early-phase clinical trials showed impressive response rates of approximately 70% with talquetamab in patients with relapsed/refractory multiple myeloma, a previously unseen response rate in this patient population, which is typically refractory to most treatments, Schinke expands. With these encouraging results from early clinical trials, investigators moved this research to a phase 1/2 clinical trial that evaluated talquetamab in this patient population, Schinke said.

Some patient cohorts treated with talquetamab in the MonumenTAL-1 trial had received prior T-cell redirecting treatment or were pretreated with CAR T-cell therapy, Schinke continues. Conversely, 2 other cohorts did not receive this type of pretreatment and received talquetamab on a different dosing schedule, she adds. One cohort received talquetamab weekly, and the other cohort received talquetamab every other week, Schinke explains. Comparing the dosing schedules of these cohorts was informative because no other clinical trial evaluating a bispecific antibody in patients with multiple myeloma has incorporated different dosing schedules, Schinke says.

Based on the results of MonumenTAL-1, on August 10, 2023, the FDA granted accelerated approval to talquetamab for patients with relapsed/refractory multiple myeloma.