At the 61st American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, in Orlando, Florida, Jennifer A. Woyach, MD from the The Ohio State University Comprehensive Cancer Center discussed the Alliance A041702 trial – a randomized phase III study designed to evaluate ibrutinib (Imbruvica) plus obinutuzumab (Gazyva), compared with ibrutinib plus venetoclax (Vencelxta) and obinutuzumab in untreated older patients aged ≥ 70 years diagnosed with chronic lymphocytic leukemia (CLL).
So, in this study, we are taking patients who are aged 70 or older with previously untreated CLL. And then they will be randomized 1:1 to either ibrutinib plus obinutuzumab, or ibrutinib plus obinutuzumab, plus venetoclax. And patients who are enrolled to ibrutinib plus obinutuzumab will have the standard 6 cycles of obinutuzumab, and then will be treated indefinitely with ibrutinib.
Those patients who are randomized to the triplet arm will have the standard obinutuzumab, and then will complete a total of 14 cycles, so about one year with the ibrutinib and the venetoclax. Then at the end of that time, they'll have a response evaluation which will include CAT scans and a bone marrow biopsy, and patients who have a minimal residual disease negative complete response at that time would discontinue all therapy. Those patients that don't will then continue ibrutuinib indefinitely. So, the primary outcome of this study is going to be to look at progression free survival between those 2 arms using that strategy of a response adaptive discontinuation.