FDA approves ibrutinib+obinutuzumab for frontline CLL/SLL


  • David Reilly
  • Oncology drug update
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Takeaway

  • On January 28, the FDA approved ibrutinib in combination with obinutuzumab for treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Why this matters

  • This is the first nonchemotherapy regimen to receive FDA approval for treatment-naive patients with CLL/SLL.

Study design

  • The approval was based on results of the phase 3 iLLUMINATE study of ibrutinib+obinutuzumab (n=113) vs chlorambucil+obinutuzumab (n=116) in 229 treatment-naive patients with CLL/SLL.
  • Median patient age, 71 (interquartile range [IQR], 66-76) years.
  • 65% of patients had features of high-risk disease.
  • Funding: Janssen Pharmaceutical Companies of Johnson & Johnson.

Key results

  • 89% objective response rate (ORR) with ibrutinib plus obinutuzumab vs 73% with chlorambucil plus obinutuzumab.
  • At 31.3 (IQR, 29.4-33.2) months median follow-up:
    • Median PFS was not reached (95% CI, 33.6-not estimable) with ibrutinib+obinutuzumab vs a PFS of 19.0 (95% CI, 15.1-22.1) months with chlorambucil+obinutuzumab (HR, 0.23; 95% CI, 0.15-0.37; P<.0001>
  • 79% (95% CI, 70%-85%) estimated PFS at 30 months with ibrutinib plus obinutuzumab vs 31% (95% CI, 23%-40%) with chlorambucil plus obinutuzumab.
  • In patients with high-risk disease features:
    • 85% reduction in risk for progression or death (HR, 0.15; 95% CI, 0.09-0.27).

Prescribing information available here.

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