The interim analysis of the AMPLIFY Phase III trial revealed promising results for AstraZeneca’s Calquence (acalabrutinib) combined with venetoclax, with or without obinutuzumab, in treating chronic lymphocytic leukaemia (CLL). The study showed a significant improvement in progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated adult patients.
Although the data for the secondary endpoint of overall survival (OS) were not yet mature, a positive trend favored the combination therapy over standard treatments. The trial continues to assess OS as a critical secondary endpoint.
CLL, a common adult leukaemia characterized by abnormal white blood cell production, affects around 40,000 first-line patients annually. Despite being incurable, patients often live long with the disease, requiring ongoing treatment.
Dr. Jennifer R. Brown, Director of the CLL Center at Dana-Farber Cancer Institute and principal investigator, emphasized the benefits of fixed-duration regimens, which allow patients to take treatment breaks, reducing long-term side effects and improving quality of life.
Susan Galbraith, AstraZeneca’s Executive Vice President of Oncology R&D, highlighted the trial’s potential to make Calquence the only second-generation BTK inhibitor available for both continuous and fixed-duration treatments.
Safety results were consistent with known profiles, with no new safety signals and low cardiac toxicity rates observed. The data will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
Notes on CLL and AMPLIFY Trial
CLL is marked by an accumulation of abnormal lymphocytes, affecting the marrow’s ability to produce normal blood cells, potentially leading to anaemia, infection, and bleeding. The AMPLIFY trial, a global, open-label Phase III study, compared Calquence and venetoclax, with or without obinutuzumab, to standard chemoimmunotherapy. Key endpoints include PFS, OS, event-free survival, overall response rate, and duration of response.
Calquence and AstraZeneca in Haematology
Calquence is a second-generation BTK inhibitor, approved in multiple regions for treating CLL, small lymphocytic lymphoma, and mantle cell lymphoma. AstraZeneca is committed to advancing haematology care, with a focus on developing innovative treatments for malignant and rare blood disorders.
About AstraZeneca
AstraZeneca is a global biopharmaceutical company headquartered in Cambridge, UK. It focuses on Oncology, Rare Diseases, and BioPharmaceuticals, offering innovative medicines in over 125 countries.
