AstraZeneca announced that its blood cancer drug Calquence (acalabrutinib) has met its primary endpoint at interim analysis in the phase III Ascend (ACE-CL-309) trial.
The trial results demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Calquence monotherapy compared against a combination regimen of rituximab plus physician’s choice of idelalisib or bendamustine.
Calquence is an inhibitor of Bruton tyrosine kinase (BTK) and it binds covalently to BTK for the inhibition of its activity.
According to the company, the safety and tolerability of Calquence was consistent with the known profile, and Ascend is the first of two phase III CLL trials expected to read out this year, while the second is Elevate-TN (ACE-CL-007) in treatment-naïve and front-line chronic lymphocytic leukaemia (CLL).
Ascend is a global, randomized, multicenter and open-label phase III study designed to evaluate the efficacy of Calquence in previously-treated patients with CLL.
The company has randomized 310 patients into two groups in the study. Patients in the first group secured Calquence monotherapy, while patients in the second group received rituximab plus physician’s choice of idelalisib or bendamustine.
The PFS assessed by an independent review committee (IRC) is the primary endpoint of the trial, while major secondary endpoints comprise of physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient reported outcomes and time to next treatment (TTNT).
In October 2017, Calquence secured accelerated approval from the US Food and Drug Administration (FDA) to treat adult patients with MCL who have received at least one prior therapy.
AstraZeneca R&D Oncology executive vice president José Baselga said: “Calquence is the first BTK inhibitor to show benefit in a Phase III trial as a monotherapy compared to current standard-of-care combinations used in relapsed or refractory chronic lymphocytic leukaemia. We look forward to presenting detailed results at a forthcoming medical meeting.”
At present, Calquence was approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, the UAE, and Qatar. It is also being developed to treat CLL and other blood cancers.