Fixed-duration acalabrutinib plus venetoclax with or without obinutuzumab improved progression-free survival over fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab in treatment-naïve chronic lymphocytic leukemia (TN CLL), according to an interim analysis of the AMPLIFY trial.
The analysis was presented by Jennifer Brown, MD, PhD, at the 66th American Society of Hematology Annual Meeting and Exposition held between December 7 and 10 in San Diego, California.
AMPLIFY is the first randomized study to evaluate a fixed-duration regimen of venetoclax with a second-generation Bruton tyrosine kinase inhibitor (BTKi), according to the authors.
The trial assessed the efficacy and safety of fixed-duration acalabrutinib-venetoclax (±obinutuzumab) vs the investigator’s choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab per standard dosing protocol in fit patients with TN CLL.
Both acalabrutinib-venetoclax and acalabrutinib-venetoclax-obinutuzumab provided a statistically significant improvement in blinded independent central review (BICR)-assessed progression-free survival over the control arm (P=0.0038 and P<0.0001, respectively).
The BICR-assessed overall response rate was also higher with acalabrutinib-venetoclax (92.8%) and acalabrutinib-venetoclax-obinutuzumab (92.7%) vs. the control arm (75.2%; descriptive P<0.0001 for both comparisons).
“The combinations of acalabrutinib-venetoclax and acalabrutinib-venetoclax-obinutuzumab provided deep and durable responses with manageable safety profiles, with acalabrutinib-venetoclax offering the first all-oral fixed-duration regimen that combines venetoclax with a second-generation BTKi in fit patients with TN CLL,” Dr. Brown and colleagues concluded.
Reference
Brown J, Seymour J, Jurczak W. Fixed-duration acalabrutinib-venetoclax with or without obinutuzumab versus chemoimmunotherapy for first-line treatment of chronic lymphocytic leukemia: interim analysis of the multicenter, open-label, randomized, phase 3 AMPLIFY trial. Abstract #1009. American Society of Hematology Annual Meeting and Exposition; December 7-10; San Diego, California
