- Add-on daratumumab with bortezomib+dexamethasone maintained significant benefits with a consistent safety profile after a median follow-up of ≥3 years in patients with relapsed/refractory multiple myeloma (RRMM) in the CASTOR trial.
Why this matters
- New treatment options are needed for patients with multiple myeloma, as response decreases with subsequent lines of therapy.
- Phase 3 clinical trial of 498 patients with RRMM and ≥1 prior line of treatment, randomly assigned to receive bortezomib+dexamethasone with or without daratumumab for 8 cycles until disease progression.
- Funding: Janssen Research & Development.
- Median follow-up, 40.0 months.
- Adding daratumumab to bortezomib+dexamethasone significantly prolonged median PFS in the intent-to-treat (ITT) population (16.7 vs 7.1 months; HR, 0.31; P<.0001>
- PFS benefit was also observed in:
- Patients with 1 prior line of treatment (1PL: 27.0 vs 7.9 months; HR, 0.22; P<.0001>
- Lenalidomide-refractory patients (7.8 vs 4.9 months; HR, 0.44; P=.0002).
- Add-on daratumumab significantly increased minimal residual disease negativity rates (10−5) in ITT analysis (14% vs 2%) and the 1PL subgroup (20% vs 3%, both P<.0001>
- PFS benefit was also observed with subsequent therapy at relapse in the ITT (HR, 0.48; P<.0001 and populations>
- No new safety concerns observed.
- Open-label design.