ASH 2025 | MonumenTAL-2 safety & efficacy results: talquetamab + pomalidomide in patients with RRMM

At this ASH meeting, I had the privilege of providing an update of the safety and efficacy data of a monumental Phase Ib study exploring the combination of talquetamab in combination with pomalidomide in patients with relapsed refractory multiple myeloma. Talquetamab is a first-in-class bispecific antibody T-cell engager targeting GPRC5D and CD3. Pomalidomide is an immunomodulatory drug that has T-cell enhancing capacity as well as direct tumor cytotoxic effect, making this combination a biologically compelling combination. The Part 1B of the Monumental 2 study enrolled 35 patients. These were heavily pretreated patients with a median of 3 and up to 12 prior lines of therapy. Around three-quarters of these patients were triple-class exposed or refractory. And importantly, a proportion of patients also had prior BCMA-targeted therapy, just underscoring the challenging patient population that was involved in this study. Talquetamab was given at 0.4 mg per kg every week or 0.8 mg per kg every two weeks after a step-up dosing. And pomalidomide was only introduced at the beginning of cycle 2 at 2 mg orally daily, days 1 to 21 in a 28-day cycle and then escalating as tolerated to a 4 milligram and treatment continued until disease progression. And after a longer follow-up of 20.7 months, the results remained strong. We saw a robust overall response rate of just over 85% with a VGPR or better of over 80% and a complete response or better of more than 45%. The median duration of response was not reached. The 12-month duration of response was over 70% and the median progression-free survival was reached at 25.8 months. With respect to side effects, pleasingly we saw no new safety signal and importantly there were no further treatment discontinuations because of side effects indicating that there were no cumulative toxicity with longer-term follow-up. So overall this longer follow-up data confirms the continued deep and durable response with talquetamab and pomalidomide, not only reinforcing the earlier results, but also supports the ongoing Phase 3 Monumental study that explores talquetamab and pomalidomide versus the investigator’s choice of either elotuzumab, pomalidomide, dexamethasone or pomalidomide, bortezomib and dexamethasone. So overall I think these results are really encouraging and it does inspire a lot of hope for the future of multiple myeloma

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