MonumenTAL-1 Data From Lead Author, Ajai Chari, MD

By Ajai Chari, MD - Last Updated: December 12, 2023

Ajai Chari, MD, Professor of Clinical Medicine and Director of the Myeloma Program at the University of California, San Francisco, told Blood Cancers Today about findings from the MonumentTAL-1 study that he presented at the 65th American Society of Hematology Annual Meeting & Exposition in San Diego, California.

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“MonumenTAL-1 was the study that led to the accelerated approval of talquetamab, which is the first GPRC5D-targeting therapy in myeloma; and the background to this year’s ASH abstract is, those results from MonumenTAL-1 showed, in a heavily-treated population, a response rate of over 70%, a [progression-free survival (PFS)] of 14 months for the 0.8 mg/kg every two week dosing, and, encouragingly, we didn’t see a lot of infectious complications, in particular, not a lot of COVID deaths.”

The trial included over 350 patients with myeloma, and Dr. Chari noted that PFS was nearly identical between high- and standard-risk disease subgroups, “which is something we almost never see because typically high-risk patients respond, but they tend not to be lasting.”

Dr. Chari did discuss some unique side effects resulting from on-target, off-tumor activity with talquetamab including loss of taste, palmar plantar peeling, other rashes of the body, and nail changes. “I would say of those the one that can be the most challenging for patients, and therefore the treatment team, is the [loss of] taste.”

Primarily, MonumenTAL-1 examined if the dosing of talquetamab could be reduced in intensity to mitigate the side effects. In an initial retrospective cohort analysis, the authors found that response, PFS, and duration of response did not seem to be adversely impacted by less frequent dosing.

To verify this finding, researchers enrolled a prospective cohort of 19 patients with myeloma to examine the effects of a dose or schedule reduction on disease control. Patients swapped from 0.8 mg/kg every two weeks to either 0.4 mg/kg every two weeks or 0.8 mg/kg once a month.

“What we found in these 19 patients was the same thing, no drop in response or PFS, and duration of response seemed comparable with the overall cohort, so that was encouraging to see. But we also saw a hint that some of these toxicities got better.”

Dr. Chari highlighted that future studies are going to further examine the loss of taste to get a better understanding of the impact of talquetamab, “but until we get that, we have this dosing strategy,” he closed.

Post Tags:ASHNEWS2023
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