AstraZeneca's Calquence Gains EU Approval: A Game-Changer for CLL Treatment

Key Information from AstraZeneca's 6-K Filing

Company Overview

• Company Name: AstraZeneca PLC
• Headquarters: Cambridge Biomedical Campus, Cambridge, UK
• SEC File Number: 001-11960
• Filing Date: June 6, 2025

Product Approval

• Product: Fixed-duration Calquence (acalabrutinib)
• Indication: Approved in the European Union for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) in the first-line setting.
• Combination Therapy: Approved in combination with venetoclax, with or without obinutuzumab.

Clinical Trial Results

• AMPLIFY Phase III Trial:
• Purpose: Evaluating efficacy and safety of Calquence combinations versus standard-of-care chemoimmunotherapy for untreated CLL.
• Key Findings:
• • Progression-Free Survival (PFS):
  • 77% of patients on Calquence plus venetoclax and 83% on Calquence plus venetoclax with obinutuzumab were progression-free at three years.
  • Compared to 67% for standard chemoimmunotherapy.
  • Median PFS was not reached for the experimental arms vs. 47.6 months for chemoimmunotherapy.
  • Risk Reduction:
  • Calquence plus venetoclax reduced progression or death by 35% (HR 0.65, p=0.0038).
  • Calquence plus venetoclax with obinutuzumab demonstrated a 58% reduction in risk (HR 0.42, p<0.0001).

Market Context

• CLL Prevalence: CLL is the most common type of leukaemia in adults, with approximately 27,000 new cases diagnosed in the UK, France, Germany, Spain, and Italy in 2024.
• Patient Treatment: An estimated 40,000 people are treated for CLL in the first line across multiple countries, including the US and Europe.

Statements from Key Personnel

• Barbara Eichhorst, MD: Highlighted the importance of fixed-duration treatment in minimizing long-term side effects and improving treatment adherence.
• Dave Fredrickson, EVP, Oncology: Emphasized that this approval offers a new treatment option that is the first all-oral combination treatment with a second-generation BTK inhibitor in the EU.

Safety Profile

• The safety and tolerability of Calquence were consistent with prior known profiles, with no new safety signals identified.

Regulatory Status

• Applications for the approved regimens are under review in several other countries based on AMPLIFY trial results.

Summary

AstraZeneca has received EU approval for a fixed-duration regimen of Calquence in combination with venetoclax, targeting a significant patient population with untreated CLL. The approval is supported by robust clinical trial data indicating improved outcomes compared to existing therapies, which may enhance AstraZeneca's position in the oncology market.