Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (Nasdaq: AZN) on Monday announced positive interim results from the AMPLIFY Phase III trial. A fixed-duration regimen of Calquence (acalabrutinib) combined with venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) in first-line chronic lymphocytic leukaemia (CLL) compared to standard chemoimmunotherapy.
A favourable trend in overall survival (OS) was also observed, although the data remains immature. The trial will continue to assess OS as a key secondary endpoint.
CLL, the most common adult leukaemia worldwide, is driven by abnormal white blood cell production. Despite being incurable, patients often live with CLL for years. The safety profile of the Calquence combination was consistent with existing data, showing low cardiac toxicity.
AMPLIFY is a global, multi-centre, open-label Phase III trial comparing Calquence combinations against chemoimmunotherapy in untreated CLL patients. Patients were randomised to receive Calquence with venetoclax, with or without obinutuzumab, or standard chemoimmunotherapy. Primary and secondary endpoints include PFS and OS.
Calquence, a second-generation BTK inhibitor, has treated over 80,000 patients globally and is approved for CLL and SLL in the US, EU and several other countries. It is also approved for mantle cell lymphoma (MCL) in the US and China. AstraZeneca is expanding Calquence's clinical evaluation in various B-cell blood cancers.
Based in Cambridge, UK, AstraZeneca focuses on prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals. Its innovative drugs are sold in over 125 countries, benefiting millions of patients globally. The company remains committed to advancing haematology and oncology, leveraging recent acquisitions like Alexion and Gracell Biotechnologies to expand its pipeline and deliver novel therapies. The company aims to revolutionize cancer care and ultimately eliminate cancer as a cause of death.
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