iLLUMINATE Trial of Ibrutinib Plus Obinutuzumab for First-Line Therapy of CLL/SLL Meets Primary Endpoint

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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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