ASH 2023: Final CENTAURUS Analysis Supports Daratumumab’s Role in Smoldering Myeloma

By: Celeste L. Dixon
Posted: Tuesday, December 19, 2023

The monoclonal antibody daratumumab potentially delayed the progression of smoldering multiple myeloma to multiple myeloma, according to the final analysis of the phase II CENTAURUS study, in which the median follow-up was about 7 years. Ola Landgren, MD, of Sylvester Comprehensive Cancer Center, University of Miami, and colleagues presented their work, which corroborated the conclusions of two earlier study analyses, during the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 210).

In CENTAURUS, eligible patients (n = 123; median age, 61 years; all diagnosed with intermediate- or high-risk smoldering multiple myeloma for up to 5 years) were randomly assigned on a 1:1:1 basis to intense, intermediate, or short dosing schedules. In each 8-week-long cycle, daratumumab was given intravenously at 16 mg/kg. The dosing schedules were as follows: intense—daratumumab once weekly (cycle 1), every 2 weeks (cycles 2 and 3), every 4 weeks (cycles 4–7), and every 8 weeks (cycles 8–20); intermediate—daratumumab once weekly (cycle 1) and every 8 weeks (cycles 2–20); short—daratumumab once weekly for just one cycle. Patients in the intense and intermediate arms could opt for further extension-phase treatment with daratumumab either intravenously or subcutaneously, at the investigator’s discretion.

In the intense and intermediate arms combined, the rate of complete response or better—a primary endpoint—was 8.5%. Median overall survival, a secondary endpoint, was not reached in any dosing arm, with 84-month overall survival rates at 81.3%, 89.5%, and 88.1% in the intense, intermediate, and short arms, respectively. Further, extended follow-up yielded no new safety concerns.

“A high proportion (44%) of patients in the intense and intermediate arms completed 20 cycles and remained on daratumumab monotherapy per investigator discretion, with a median duration of additional treatment of 46 months in the extension phase,” Dr. Landgren and co-investigators noted. Treatment-emergent adverse events that led to discontinuation of daratumumab occurred in 7.3%, 2.4%, and 5.0% of patients in the intense, intermediate, and short arms, respectively.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.

2023 ASH Annual Meeting & Exposition

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