AstraZeneca’s AMPLIFY trial interim analysis demonstrates positive results for Calquence plus venetoclax
James Spargo | July 30, 2024 | News story | Research and Development | AstraZeneca, Haematology, chronic lymphocytic leukaemia, haematology, trial analysis
AstraZeneca has announced positive high-level results from an interim analysis for its AMPLIFY phase 3 trial, combining AstraZeneca’s Calquence (acalabrutinib) with venetoclax, with or without obinutuzumab, in previously untreated adult patients with chronic lymphocytic leukaemia (CLL), compared to standard of care chemotherapy.
The results show a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). A positive trend was also shown in the secondary endpoint – overall survival (OS) – versus standard of care chemotherapy, however this data is not mature yet.
Jennifer R Brown MD PhD, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette professor of Medicine at Harvard Medical School, and principal investigator of the trial, said: “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 CLL. 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.”
Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said: “The PFS and OS results from the AMPLIFY phase 3 trial demonstrate the potential of including a Bruton tyrosine kinase (BTK) inhibitor in a fixed-duration regimen and reinforce our leadership in advancing science for patients with CLL. If approved, Calquencewould become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers.”
James Spargo
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