EHA 2019 – The addition of daratumumab results in a robust clinical benefit in transplant-eligible newly diagnosed multiple myeloma patients


  • Elena Riboldi — Agenzia Zoe
  • Univadis
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • In patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem-cell transplantation (ASCT), daratumumab plus standard of care (D-VTd) improved depth of response and progression-free survival (PFS) compared with standard of care (bortezomib/thalidomide/dexamethasone, VTd) alone.
  • The combination, administered before and after ASCT, was well tolerated.

 

Why this matters

  • D-VTd is effective in transplant-ineligible NDMM patients.
  • This is the first study showing the clinical benefit of D-VTd in transplant-eligible NDMM patients.

 

Study design

  • The two-part, phase 3 CASSIOPEIA trial enrolled 1085 transplant-eligible NDMM patients.
  • Patients were randomly assigned (1:1) to receive 4 pre-transplant induction and 2 post-transplant consolidation cycles of VTd alone or in combination with daratumumab (D-VTd).
  • The primary endpoint was the rate of post-consolidation stringent complete response (sCR) assessed at Day 100 post-ASCT.
  • Part 2 of the study (maintenance) is currently ongoing.

 

Key results

  • sCR rate was significantly higher in the D-VTd arm (29% vs 20%; OR 1.60 [95%CI 1.21-2.12]; P=0.0010).
  • 39% of patients in the D-VTd arm and 26% in the VTd arm achieved a complete response or better, 64% of patients in the D-VTd arm and 44% in the VTd arm achieved minimal residual disease-negativity (10−5, assessed by multiparametric flow cytometry; both P
  • With median PFS not reached in either arm, 18-month PFS rates were 93% versus 85% in the D-VTd and VTd arm, respectively (HR 0.47 [95% CI 0·33–0·67]; P
  • 46 deaths on study were observed (14 in the D-VTd arm and 32 in the VTd arm; HR 0.43 [95% CI, 0.23-0.80], however overall survival data are immature.
  • The most common grade 3 or 4 adverse events were neutropenia (28% in the D-VTd arm vs 15% in the VTd arm), lymphopenia (17% vs 10%), thrombocytopenia (11% vs 7%), and stomatitis (13% vs 16%).