Company: AZN
Filing Date: 2025-06-06
Form Type: 6-K
Source: 0001654954-25-006655
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-06-06
Form: 6-K
Chunk 1
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 the pivotal AMPLIFY Phase III trial , presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine . 1

Results from the AMPLIFY trial showed 77% of patients treated with Calquence plus venetoclax and 83% of patients treated with Calquence plus venetoclax and obinutuzumab were progression free at three years, versus 67% of patients treated with standard-of-care chemoimmunotherapy (investigator's choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab). 1 Median progression-free survival (PFS) was not reached for either experimental arm versus 47.6 months for chemoimmunotherapy. 1 Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy (hazard ratio [HR] 0.65; 95% confidence interval [CI] 0.49-0.87; p=0.0038). Calquence plus venetoclax with obinutuzumab demonstrated a 58% reduction in the risk of disease progression or death compared to chemoimmunotherapy (HR 0.42; 95% CI 0.30-0.59; p<0.0001). 2

CLL is the most common type of leukaemia in adults. An estimated 27,000 people were diagnosed with CLL in the UK, France, Germany, Spain and Italy in 2024. 3

Barbara Eichhorst, MD, University Hospital Cologne, Cologne, Germany and investigator for the AMPLIFY trial, said: "For patients diagnosed with chronic lymphocytic leukaemia, this approval provides a new option in the first-line setting that may help to minimize long-term side effects and reduce drug resistance as they may occur with continuous treatment. A fixed-duration regimen is appealing to patients and helps with adherence during the treatment period."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Today's approval brings a new fixed-duration treatment option to patients with previously untreated chronic lymphocytic leukaemia across Europe. Calquence plus venetoclax is the first and only all-oral combination treatment option with a second-generation BTK inhibitor approved in the EU and provides patients and their physicians