CALQUENCE® Data To Show Improved Progression-Free Survival In Phase III Front-Line Chronic Lymphocytic Leukemia At ASH 2019 Annual Meeting

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Robust early-stage pipeline advancements and presentations across multiple scientific platforms demonstrate potential to improve treatment outcomes in blood cancers with high unmet need

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca will present the first data from the Phase III ELEVATE-TN trial assessing CALQUENCE® (acalabrutinib), a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor, in patients with previously untreated chronic lymphocytic leukemia (CLL), as well as data from novel-combination trials across multiple blood cancers at the 2019 American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, USA, December 7-10.

The Company will present over 30 abstracts, including seven oral presentations, in CLL, mantle cell lymphoma (MCL), acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and multiple myeloma (MM). Key data include:

  • The first presentation of data from the pivotal Phase III ELEVATE-TN trial evaluating CALQUENCE in combination with obinutuzumab and CALQUENCE monotherapy versus obinutuzumab combined with chlorambucil chemotherapy in previously untreated CLL
  • Long-term efficacy, safety and tolerability data on CALQUENCE in relapsed or refractory CLL from the Phase I/II ACE-CL-001 trial
  • First-time data on roxadustat as a potential new treatment for anemia in patients with primary myelodysplastic syndromes (MDS)

Dave Fredrickson, Executive Vice President, Oncology Business Unit said: “AstraZeneca continues to demonstrate its strength in hematology, presenting new research at ASH that spans targeted therapies across eight blood cancers. This year we are especially excited to present the ELEVATE-TN data demonstrating the impressive efficacy and tolerability of CALQUENCE in 1st-line chronic lymphocytic leukemia.”

 

Key headline data from the CALQUENCE Phase III ELEVATE-TN trial

 

Efficacy measure

CALQUENCE plus

obinutuzumab

N = 179

CALQUENCE

monotherapy

N = 179

Obinutuzumab

plus chlorambucil

N = 177

Stratified analysis, median follow-up 28 months

Hazard ratio for PFS endpoint (vs. obinutuzumab + chlorambucil), stratified analysis

HR 0.10 (primary endpoint) 95% CI 0.06–0.17,

p

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