Dr. Rogers on the Next Steps With Obinutuzumab/Ibrutinib/Venetoclax in CLL

Kerry A. Rogers, MD, hematologist/oncologist, assistant professor, Department of Hematology, The Ohio State University Comprehensive Cancer Center–James, discusses the next steps with the triplet combination of obinutuzumab (Gazyva), ibrutinib (Imbruvica), and venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL).

During the 2020 ASH Annual Meeting and Exposition, findings from the 3-year analysis of a phase 1/2 study (NCT02427451) evaluating the fixed-duration triplet demonstrated high rates of overall response and undetectable minimal residual disease in patients with CLL.

Currently, the dose-expansion portion of the study is evaluating the triplet in patients who did not achieve a complete response after 1 year of ibrutinib or who have molecular resistance, defined as the presence of mutations known to confer clinical resistance, says Rogers. Data from the study will provide additional insight into the safety profile of the regimen, as well as demonstrate preliminary efficacy data in the expansion cohorts, Rogers adds.

The triplet regimen could offer patients with CLL a tolerable and effective fixed-duration regimen that could eliminate leukemia and limit the need for indefinite treatment with BTK inhibitors, such as ibrutinib, Rogers says. In turn, patients could have decreased clinical and financial toxicity with the fixed-duration regimen, Rogers explains.

Additionally, the combination may have utility in other CLL populations, as well as other B-cell malignancies, says Rogers. The triplet is also being evaluated vs ibrutinib/obinutuzumab in an ongoing phase 3 study (NCT03701282) for previously untreated younger patients with CLL.