Vincent Rajkumar, Oncologist at Mayo Clinic specializing in Myeloma, Amyloidosis, Macroglobulinemia, MGUS, and Related Disorders, shared on X:
“Just out ASH abstracts online: I will present overall survival results of AQUILA trial in high risk smoldering myeloma at ASH26
Overall survival was significantly improved with Dara; significant 48% reduction in risk of death (HR 0.52; 95% CI, 0.32–0.87; P=0.0108). The 7-year OS rate was 87.8% with Dara versus 78.7% with observation. Learn more at the live meeting.”
Title: Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma
Authors: Meletios A. Dimopoulos, Peter M. Voorhees, Fredrik Schjesvold, Yael C. Cohen, Vania Hungria, Irwindeep Sandhu, Jindriska Lindsay, Ross I. Baker, Kenshi Suzuki, Hiroshi Kosugi, Mark-David Levin, Meral Beksac, Keith Stockerl-Goldstein, Albert Oriol, Gabor Mikala, Gonzalo Garate, Koen Theunissen, Ivan Spicka, Anne K. Mylin, Sara Bringhen, Katarina Uttervall, Bartosz Pula, Eva Medvedova, Andrew J. Cowan, Philippe Moreau, Maria-Victoria Mateos, Hartmut Goldschmidt, Tahamtan Ahmadi, Linlin Sha, Annelore Cortoos, Eva G. Katz, Els Rousseau, Liang Li, Robyn M. Dennis, Robin Carson, and S. Vincent Rajkumar, for the AQUILA Investigators.
The AQUILA trial is an international Phase 3 study that looked at whether daratumumab could benefit patients with high-risk smoldering multiple myeloma (SMM) by treating the disease before it develops into active multiple myeloma.
- Objective: To see whether early treatment can delay the progression of high-risk SMM and improve patients’ survival.
- Treatment: Daratumumab (Darzalex), an antibody that targets the CD38 protein on abnormal plasma cells.
- Study design: 390 patients were assigned to receive either daratumumab or active monitoring without immediate treatment.
- Progression-free survival: Patients receiving daratumumab had a 51% lower risk of disease progression or death compared with those under observation.
- Overall survival: The latest seven-year results showed a 48% reduction in the risk of death in the daratumumab group (HR 0.52).
- Survival rates: Seven-year overall survival was 87.8% with daratumumab, compared with 78.7% with observation.
- Clinical significance: The findings suggest that treating high-risk patients earlier may help prevent disease progression and improve long-term outcomes.
- FDA approval: In November 2025, daratumumab became the first FDA-approved treatment specifically for adults with high-risk smoldering multiple myeloma.
Read more articles featuring Vincent Rajkumar on OncoDaily.