CALQUENCE (acalabrutinib)

Chronic lymphocytic leukaemia (CLL) monotherapy

CALQUENCE is a treat to progression therapy with durable efficacy, with 62% of previously untreated patients progression-free at 6 years (exploratory analysis)3,4*

UK real-world evidence from the EPIC programme reinforces the efficacy and safety profile seen in the ELEVATE-TN clinical trial1-3,5

>100,000 patients have been treated worldwide with CALQUENCE, including patients with comorbidities6

CALQUENCE (acalabrutinib) + venetoclax

CLL fixed duration therapy

CALQUENCE (acalabrutinib) + venetoclax is the only licensed 2nd generation BTKi available as a fixed duration combination in first-line CLL1,2,7

Delivers disease control with 77% of patients estimated to be progression-free at 3-years vs 67% with FCR/BR (HR=0.65; 95% CI: 0.49-0.87; P=0.004)2,4†

CALQUENCE + venetoclax provides an all oral mode of administration offering patients an infusion-free treatment pathway1

Explore our ELEVATE-TN trial for Calquence monotherapy

Explore our AMPLIFY trial for Calquence as a fixed duration therapy

Therapeutic indications1

 

FOR FIRST-LINE CLL:

CALQUENCE as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated CLL

CALQUENCE in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated CLL

 

FOR PREVIOUSLY TREATED CLL:

CALQUENCE as monotherapy is indicated for the treatment of adult patients with CLL who have received at least one prior therapy

Footnote:
*Based on an exploratory analysis of 6-year follow-up data from ELEVATE-TN3

†Median follow-up from randomization: 40.8 months (range, 0–59 months). Hazard ratio (95% CI) computed using a Cox proportional-hazards model. P-value based on stratified log-rank test

 

Abbreviations:
1L, first line; BR, bendamustine-rituximab; BTKi, Bruton’s tyrosine kinase inhibitor; CI, confidence interval; CLL, chronic lymphocytic leukaemia; EPIC, Early Access Programme Outcomes in acalabrutinib; FCR, fludarabine-cyclophosphamide-rituximab; HR, hazard ratio; PFS, progression-free survival; RWE, real-world evidence.

 

References:

1. Calquence (acalabrutinib) 100 mg SmPC – UK. 2.Brown et al. N Engl J Med. 2025;392(8):748-762 and supplementary information. 3. Sharman JP, et al. Blood. 2025; doi:10.1182/blood.2024024476. 4. Brown et al, Presented at ASH Annual Meeting; December 7-10, 2024. Oral Presentation P1009. 5. Martinez-Calle, Nicolas, Walewska, Renata, Panees, Shankara et al. OUTCOMES OF EPIC. EHA 2024. Abstract #1256. 6. Internal AstraZeneca Data on File. May 2025. REF-274119. 7. Zanubrutinib 80mg hard capsules Summary of Product Characteristics.

Adverse events should be reported

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AstraZeneca by visiting contactazmedical.astrazeneca.com or by calling 0800 783 0033.

November 2025 I GB-69425