MM: maintenance ixazomib extends PFS in TOURMALINE-MM3

  • Dimopoulos MA, et al.
  • Lancet
  • 10 Dec 2018

  • curated by David Reilly
  • Univadis Clinical Summaries
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 (MM), maintenance ixazomib after autologous stem cell transplantation (ASCT) delivered a significant improvement in PFS, deepened responses, and converted more patients to minimal residual disease (MRD)-negative status vs placebo.

Why this matters

  • Patients with MM are at high risk for relapse after ASCT.

Study design

  • Phase 3 TOURMALINE-MM3 randomized study compared maintenance treatment with ixazomib (n=395) vs placebo (n=261) after ASCT in patients with newly diagnosed MM.
  • Median patient age: 58 (IQR, 52-64) years.
  • Funding: Millennium Pharmaceuticals.

Key results

  • Median PFS: 26.5 (95% CI, 23.7-33.8) months with ixazomib vs 21.3 (95% CI, 18.0-24.7) months with placebo (HR, 0.72; 95% CI, 0.58-0.89; P=.0023).
  • 53% of patients receiving ixazomib converted from partial response (PR) to very good PR or better (≥VGPR) during the study vs 34% with placebo (relative risk [RR], 1.54; 95% CI, 0.94-2.54).
  • 46% experienced deepening response during treatment with ixazomib vs 32% with placebo (RR, 1.41; 95% CI, 1.10-1.80; P=.0042).
  • 12% of patients converted to MRD negativity at any time during the study with ixazomib vs 7% with placebo.

Limitations

  • Lenalidomide would been a more fitting comparator for ixazomib.