AstraZeneca has said that the use of Calquence (acalabrutinib) significantly prolonged the time patients live without progression of disease in relapsed or refractory chronic lymphocytic leukaemia (CLL).
The company disclosed the results from an interim analysis of the Phase III Ascend trial at the European Hematology Association (EHA) Annual Congress in Amsterdam.
Calquence was compared with rituximab, recommended by the physician, combined with idelalisib (IdR) or bendamustine (BR) in patients with relapsed or refractory CLL.
The company said that at a median follow-up of 16.1 months, the trial results showed an 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%.
According to AstraZeneca, the median time without disease progression for patients treated with Calquence has not yet been reached when compared with 16.5 months in the control arm.
At 12 months, 88% of patients treated with Calquence did not show disease progression compared to 68% for the control arm.
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The company claimed that the safety and tolerability of the new drug was consistent with its established profile.
Ascend is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously-treated patients with CLL.
The trial saw 310 patients randomised into two arms. Patients in the first arm were administered Calquence monotherapy (100mg twice daily until disease progression), whereas patients in the second arm received either rituximab in combination with idelalisib or rituximab in combination with bendamustine.
The primary endpoint is PFS assessed by an independent review committee (IRC). Secondary endpoints include physician-assessed PFS, IRC and physician-assessed overall response rate and duration of response, overall survival, patient-reported outcomes and time to next treatment.
The US Food and Drug Administration (FDA) granted accelerated approval for Calquence in October 2017 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Currently, the drug is approved for the treatment of adults with relapsed or refractory MCL in the US, Brazil, the UAE and Qatar, and is being developed for the treatment of CLL and other blood cancers.