AMPLIFY Infection Rates With Acalabrutinib Plus Venetoclax

Danielle M. Brander, MD, of Duke University School of Medicine, reviews infection data from the AMPLIFY trial in chronic lymphocytic leukemia (CLL), which randomized patients to chemoimmunotherapy, acalabrutinib plus venetoclax, or acalabrutinib plus venetoclax plus obinutuzumab. Serious or grade 3 or higher infections occurred in 14% of patients on the doublet versus 25% on the triplet, with fatal infections in about 3% and 6%, respectively; the doublet gained FDA approval this year while the triplet is not approved in the United States. Marc J. Braunstein, MD, PhD, of NYU Grossman Long Island School of Medicine, says adding immune-modifying agents raises infections and that neutropenia and infection are more common concerns with venetoclax than tumor lysis syndrome. For a fit patient without higher-risk features he considers the doublet reasonable and follows its label. Dr Brander adds that AMPLIFY enrolled during the COVID-19 pandemic and that the censored analysis still points to a real infection signal.