The phase III iLLUMINATE (PCYC-1130) trial recently met its primary endpoint of improvement in progression-free survival. The study evaluated ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), the most common adult hematologic malignancy. Specifically, the study met its primary endpoint for a clinically and statistically significant difference in progression-free survival for patients treated with ibrutinib plus obinutuzumab vs those who received chlorambucil plus obinutuzumab, as assessed by an independent review committee.
Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor and is U.S. Food and Drug Administration–approved for treatment in six disease indications. Ibrutinib has the longest follow-up data as a BTK therapy in CLL.
iLLUMINATE is a randomized, multicenter, open-label, phase III study of ibrutinib in combination with obinutuzumab vs chlorambucil in combination with obinutuzumab in patients with previously untreated CLL/SLL. According to the study protocol, patients enrolled are aged 65 years and older or, if less than age 65 years, must have at least one of the following criteria: Cumulative Illness Rating Score (CIRS) > 6 and creatinine clearance estimated < 70 mL/min using the Cockcroft-Gault equation.
In the study, patients were randomized to receive ibrutinib at 420 mg continuously in combination with obinutuzumab at 1,000 mg intravenously over 6 cycles or chlorambucil on days 1 and 15 of each cycle plus obinutuzumab at 1,000 mg intravenously over 6 cycles.
The primary endpoint is progression-free survival by independent review committee. Secondary objectives include overall response rate and rate of minimal residual disease–negative responses.
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