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CENTAURUS: A phase II trial of daratumumab monotherapy for intermediate/high-risk smoldering MM
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Smoldering MM is an asymptomatic precursor to MM, with high-risk patients experiencing a substantial risk of progression to MM within 5 years of diagnosis.1 Although active surveillance is currently the standard approach, early intervention strategies are being explored to assess their potential impact on disease progression.1 The phase II CENTAURUS trial (NCT02316106; N = 123) evaluated daratumumab monotherapy in patients with intermediate/high-risk smoldering MM across three dosing regimens: long intense, intermediate, and short intense (n = 41 each).1 All schedules included IV daratumumab at 16 mg/kg, delivered in 8-week cycles. The long and intermediate regimens extended to 20 cycles with optional extension periods, whilst the short intensive regimen was delivered in a single cycle once weekly.1 Landgren et al.1 published the final analysis from the CENTAURUS trial in Blood.
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| Key learnings |
| At a median follow up of 85.2 months, ORRs were 58.5%, 53.7%, and 37.5% in the long intense, intermediate, and short intense arms, respectively. The ≥CR rates were 4.9%, 9.8%, and 0%. |
| Median PFS, including the extension phase, was not reached in the long intense arm, 84.4 months in the intermediate arm, and 74.1 months in the short intense arm. Median OS was not reached in any arm. |
| No new safety concerns were observed with extended daratumumab exposure by a median follow-up of ~7 years. TEAEs were most frequent in the long intense arm; however, discontinuation rates due to TEAEs were similar across all cohorts. |
| These extended follow-up data support further investigation of daratumumab as an early intervention for smoldering MM and inform treatment strategies for intermediate/high-risk smoldering MM, influencing the design of the phase III AQUILA (NCT03301220) study. |
Abbreviations: CR, complete response; IV, intravenous; MM, multiple myeloma; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; TEAE, treatment emergent adverse event.
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