ASH 2019 – Waldenström's macroglobulinemia: maintenance rituximab fails phase 3


  • W. Todd Penberthy, Ph.D.
  • Univadis
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Takeaway

  • 2-year rituximab maintenance fails to demonstrate a survival advantage vs observation at 70 months follow-up in patients with advanced Waldenström's macroglobulinemia who responded to first-line bendamustine plus rituximab.
  • Exploratory analysis showed a survival benefit in patients aged

Why this matters

  • Waldenström's macroglobulinemia has worse prognosis with limited treatment options; novel therapies are warranted to improve outcomes.

Study design 

  • Prospective, randomized, multicenter phase 3 the StiL NHL7-2008 MAINTAIN trial.
  • 218 patients with advanced Waldenström's macroglobulinemia were randomly assigned to either rituximab maintenance for 2 years or observation after first-line treatment with bendamustine plus rituximab.
  • Primary endpoint was PFS.
  • Secondary endpoints included response rates, OS, and toxicity.
  • Funding: Sandoz; Janssen; Celgene; Roche Pharma AG.

Key results

  • Median follow-up time was 70.2 months.
  • Median OS was not reached in either group; no difference was observed in OS between the groups.
  • 91.4% of patients responded to induction bendamustine+rituximab.
  • Median PFS was 101 months in the maintenance group and 83 months in the observation group (HR, 0.80; P=.32).
  • Exploratory analysis showed a survival benefit in patients aged

Limitations

  • Safety data not reported.