- 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.
- 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.
- 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.