First-line daratumumab shows high efficacy and tolerability even in advanced AL amyloidosis: the real-world experience

ESMO Open. 2021 Apr;6(2):100065. doi: 10.1016/j.esmoop.2021.100065. Epub 2021 Mar 2.

Abstract

Background: Daratumumab was the first monoclonal CD38 antibody with single-agent activity approved for the treatment of multiple myeloma. Moreover, daratumumab demonstrated high response rates in relapsed immunoglobulin light-chain (AL) amyloidosis.

Patients and methods: In our single-center retrospective real-life case series, we analyzed the efficacy and safety of daratumumab as first-line treatment. Daratumumab was administered with low-dose dexamethasone alone or in combination with other multiple myeloma therapeutics RESULTS: Fourteen patients were eligible, including nine patients with cardiac stage IIIa or IIIb. Overall hematologic response rate was 100%, with 64.3% achieving complete response after a median of 16 cycles of treatment. Median time to hematologic response was 1.4 months. Organ response rates were 45.5% after a median of 4.0 months and 66.7% after a median of 10.0 months, for heart and kidney involvement, respectively. After a median follow-up of 20.5 months, two patients underwent successful autologous stem cell transplantation (ASCT), while another three patients were in preparation for ASCT. Three patients remained on daratumumab at the last follow-up. There were no unexpected toxicities and no grade III or IV adverse events, although more than half of our patients were in stage IIIa or IIIb.

Conclusion: Daratumumab proved to be highly effective in newly diagnosed AL amyloidosis with excellent hematologic and organ response rates, a remarkable safety profile, and good tolerability even in patients with advanced stage of disease.

Keywords: AL; amyloidosis; daratumumab; immunotherapy; light chain.

MeSH terms

  • Antibodies, Monoclonal
  • Hematopoietic Stem Cell Transplantation*
  • Humans
  • Immunoglobulin Light-chain Amyloidosis* / drug therapy
  • Retrospective Studies
  • Transplantation, Autologous
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • daratumumab