Relapsed/refractory patients

NICE to make daratumumab, bortezomib and dexamethasone triplet available in England via the cancer drugs fund 

It has been announced today, 12 February, 2019, that the National Institute for Health and Care Excellence (NICE), will make the triplet regimen; daratumumab (Darzalex®), bortezomib (Velcade®) and dexamethasone (DVd), available to patients with multiple myeloma (MM) in England through the Cancer Drugs Fund (CDF). Patients will be eligible to receive DVd if they have already received one prior line of therapy. The triplet regimen will not, however, be routinely available until the long-term survival benefit can be supported by further data and re-evaluated by NICE.1

Background

Daratumumab is an anti-CD38 monoclonal antibody, bortezomib is a proteasome inhibitor and dexamethasone is a corticosteroid. This triplet combination was compared to bortezomib-dexamethasone (Vd) alone in the phase III CASTOR trial (NCT02136134).2

Data given as DVd versus Vd

  • Multi-center, open-label, randomized, active-controlled, phase III study
  • Patients with relapsed/refractory MM
  • Patients were randomized 1:1 to DVd or Vd (N = 498):
    • DVd (n = 251)
    • Vd (n = 247)
  • Median follow-up: 19.4 months (0–27.7)
  • Progression-free survival (PFS): 16.7 vs 7.1 months (HR: 0.31, 95% CI, 0.24–0.39, P < 0.0001)
  • Overall response rate: 83.8% vs 63.2% (P < 0.0001)
  • PFS survival benefit was most prominent in patients who had received 1 prior line of therapy
  • DVd was superior in all subgroups, including:
    • Prior treatment exposure
    • Lenalidomide-refractory status
    • Time since last therapy
    • Cytogenetic risk
  • Minimal residual disease-negative rates were >2.5x higher in the DVd arm across subgroups
  • At the longer follow-up, DVd also maintained the reported safety profile
References
  1. Pharamphorum. NICE backs interim funding for J&J/Takeda myeloma regimen. https://pharmaphorum.com/news/nice-backs-interim-funding-for-jj-takeda-myeloma-regimen/ [accessed 2019 March 12]
  2. Spencer A. et al. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR. Haematologica. 2018 Sep 20. DOI: 10.3324/haematol.2018.194118
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