For patients with high-risk chronic lymphocytic leukemia (CLL), first-line therapy with a triple combination of targeted agents obinutuzumab (Gazyva), ibrutinib (Imbruvica), and venetoclax (Venclexta) showed encouraging response rates in the phase 2 CLL2-GIVe trial. The complete response rate at final restaging was 58.5%, and 33 patients with a confirmed response were negative for minimal residual disease after a median follow-up of 18.6 months, reported Henriette Huber, MD, of University Hospital Ulm, Germany.
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The overall safety profile of the combination was acceptable, she said, but added that “some higher-grade infections are of concern.” The rate of grade 3 or greater infections/infestations in the study was 19.5%.
Another adverse event of concern is the rate of atrial fibrillation in the comparatively young patient population (median age 62), noted Alexey Danilov, MD, PhD, of City of Hope in Duarte Calif., who commented on the study for MDedge.
He pointed out that second-generation Bruton’s tyrosine kinase (BTK) inhibitors such as acalabrutinib (Calquence) may pose a lower risk of atrial fibrillation than the BTK inhibitor ibrutinib used in the CLL2-GIVe study.
In general, however, the rationale for the combination is sound, Dr. Danilov said.
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