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AstraZeneca's Calquence: Game-Changer for Chronic Lymphocytic Leukaemia Treatment

$AZN
Form 6-K
Filed on: 2025-04-29
Source
AstraZeneca's Calquence: Game-Changer for Chronic Lymphocytic Leukaemia Treatment

Key Information and Insights from the Financial Report (6-K) on AstraZeneca PLC:

  1. Regulatory Approval:
  • AstraZeneca's Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has been recommended for approval in the European Union for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
  1. Clinical Trial Results:
  • The recommendation was based on the AMPLIFY Phase III trial, which demonstrated:
    • Statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard chemoimmunotherapy.
    • Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to standard treatment (HR 0.65, p=0.0038).
    • Calquence plus venetoclax with obinutuzumab showed a 58% reduction in the risk of disease progression or death (HR 0.42, p<0.0001).
    • At three years, 77% of patients treated with Calquence plus venetoclax and 83% of those treated with Calquence plus venetoclax and obinutuzumab were progression-free, compared to 67% for chemoimmunotherapy.
  1. Safety Profile:
  • The safety and tolerability of Calquence were consistent with its known profile, with no new safety signals identified during the trial.
  1. Market Potential:
  • CLL is the most common type of leukaemia in adults, with approximately 27,000 new cases expected in key European markets (UK, France, Germany, Spain, and Italy) in 2024.
  • The approval could position Calquence as the only all-oral second-generation BTK inhibitor for untreated CLL patients in Europe.
  1. Executive Insights:
  • Susan Galbraith, EVP of Oncology Haematology R&D at AstraZeneca, highlighted that this recommendation enhances treatment flexibility for patients and doctors, allowing for breaks in treatment to mitigate long-term adverse effects and drug resistance.
  1. Company Overview:
  • AstraZeneca is a leading global biopharmaceutical company focused on the discovery, development, and commercialization of medicines in oncology, rare diseases, and other areas, with a presence in over 125 countries.
  1. Future Developments:
  • Regulatory applications for Calquence plus venetoclax, with or without obinutuzumab, are under review in several countries based on AMPLIFY results.

Summary:

AstraZeneca's advancement of Calquence in treating CLL marks a significant development in oncology, addressing a high unmet need in a prevalent disease. The positive trial outcomes and the potential for regulatory approval in the EU underscore AstraZeneca's commitment to innovation in cancer care, promising new treatment options for patients with chronic lymphocytic leukaemia.