CALQUENCE (acalabrutinib) Significantly Prolonged the Time Patients Lived without Disease Progression in Relapsed or Refractory Chronic Lymphocytic Leukemia
AstraZeneca today announced detailed results from the interim analysis of the Phase III ASCEND trial at the European Hematology Association (EHA) Annual Congress in Amsterdam, showing CALQUENCE (acalabrutinib) significantly prolonged the time patients lived without disease progression in relapsed or refractory chronic lymphocytic leukemia (CLL).
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The ASCEND trial compared CALQUENCE with the investigator’s choice of rituximab combined with idelalisib (IdR) or bendamustine (BR) in patients with relapsed or refractory CLL.
At a median follow-up of 16.1 months, results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for patients treated with CALQUENCE vs. IdR or BR, reducing the risk of disease progression or death by 69% (HR, 0.31: 95% CI, 0.20-0.49, p<0.0001). The median time without disease progression or death for patients treated with CALQUENCE has not yet been reached vs. 16.5 months in the control arm. At 12 months, 88% of patients on CALQUENCE showed no disease progression compared to 68% for the control arm. The safety and tolerability of CALQUENCE was consistent with its established profile.
José Baselga, Executive Vice President, Oncology R&D said: “These data add to the growing body of evidence to support the profile of CALQUENCE as a selective BTK inhibitor that offers a chemotherapy-free treatment option with a favorable safety profile in chronic lymphocytic leukemia, a life-threatening disease. These data, along with our recent positive results from the Phase III ELEVATE-TN trial in previously-untreated chronic lymphocytic leukemia, will serve as the foundation for regulatory submissions later this year.”
Paolo Ghia, MD, Professor, Medical Oncology, Università Vita-Salute San Raffaele in Milan, and investigator of the ASCEND trial, said: “This is the first randomized study to directly compare a BTK inhibitor as monotherapy with standard chemoimmunotherapy or idelalisib and rituximab combinations. With a significant improvement in progression-free survival and a favorable safety profile, acalabrutinib may become an important choice for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia.”