Acalabrutinib regimens improve PFS vs. standard care in untreated CLL
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Fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, improved survival compared with standard chemoimmunotherapy for certain adults with leukemia, according to a topline data announcement.
The randomized phase 3 AMPLIFY trial included adults with previously untreated chronic lymphocytic leukemia without deletion 17p or TP53 mutations.
Researchers randomly assigned patients half of the patients to acalabrutinib (Calquence, AstraZeneca) plus venetoclax (Venclexta, AbbVie), with or without obinutuzumab (Gazyva, Genentech). The other half received investigator’s choice of chemoimmunotherapy..
PFS served as the primary endpoint. OS, EFS, overall response rate, duration of response and time to next treatment served as key secondary endpoints.
Researchers observed improved PFS among patients treated with either acalabrutinib-containing regimen compared with chemotherapy. They also reported a trend toward improved OS; however, OS data remained immature at the time of analysis.
“The AMPLIFY results demonstrate the potential of acalabrutinib and venetoclax with or without obinutuzumab to be effective and well-tolerated fixed-duration treatment options for patients with chronic lymphocytic leukemia,” Jennifer R. Brown, MD, PhD, director of the CLL Center of Dana-Farber Cancer Institute’s division of hematologic malignancies, as well as Worthington and Margaret Collette professor of medicine at Harvard Medical School, said in an AstraZeneca press release. “This is an important advance in this setting as fixed-duration regimens allow those living with this chronic disease to take breaks from their treatment, thereby decreasing the possibility of long-term adverse events and drug resistance, and improving quality of life.”
The safety and tolerability of the agents evaluated in AMPLIFY appeared consistent with their established profiles. Researchers identified no new safety signals.
Complete data from AMPLIFY will be presented at a medical meeting.
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