DARZALEX® + bortezomib + thalidomide + dexamethasone
For a strong start to their treatment journey
CASSIOPEIA study design
CASSIOPEIA is a phase 3 study comparing DARZALEX® + VTd vs VTd alone for induction and consolidation1,2
- In an ongoing part 2 of the study, patients underwent a second randomization in both treatment groups to either observation or DARZALEX® Q8W monotherapy for maintenance. The efficacy and safety of this maintenance regimen is currently being evaluated2
The primary endpoint was stringent complete response (sCR) rate at Day 100 post-transplant1,2
- sCR was defined as a CR + normal free light-chain ratio + absence of clonal plasma cells + disappearance of all plasmacytomas3
The key secondary endpoints included2-4:
- Rate of CR or better
- PFS from first randomization
- OS from first randomization
CASSIOPEIA study results
Adding DARZALEX® to VTd resulted in significantly more patients with sCR vs VTd alone after consolidation1,2
Primary endpoint: sCR assessed 100 days after transplant or immediately following consolidation if greater than 100 days.
DARZALEX® + VTd post-consolidation responses2:
- 39% of patients achieved CR or better with DARZALEX® + VTd vs 26% for VTd alone (P<0.0001)2
- 83% of patients achieved VGPR or better with DARZALEX® + VTd vs 78% for VTd alone2
- Overall response rate: 93% with DARZALEX® + VTd vs 90% with VTd alone2
53% reduction in the risk of disease progression or death with DARZALEX® + VTd vs VTd alone1,2*
*Based on interim analysis and the boundary for PFS was crossed.
- DVTd demonstrated an improvement in PFS vs VTd. With a median follow up of 18.8 months, the median PFS has not been reached in either arm.
DARZALEX® has a demonstrated safety profile when combined with VTd1
- The most frequent adverse reactions (≥20%) occurring with at least a 5% greater frequency in the DVTd arm were infusion reactions, nausea, upper respiratory tract infection, pyrexia, and bronchitis
- Serious adverse reactions with a 2% greater incidence in the DVTd arm compared with the VTd arm were bronchitis (DVTd 2% vs VTd <1%) and pneumonia (DVTd 6% vs VTd 4%)
Download a guide describing the new approval for DARZALEX® in combination with bortezomib, thalidomide, and dexamethasone for adult patients with newly diagnosed, transplant-eligible multiple myeloma.
CR=complete response; DVTd=DARZALEX® (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; HR=hazard ratio; ITT=intent to treat; MM=multiple myeloma; NDMM=newly diagnosed multiple myeloma; OR=odds ratio; OS=overall survival; PFS=progression-free survival; Q8W=every 8 weeks; VGPR=very good partial response; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).