AstraZeneca has announced that the Phase III Ascend trial of Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL) has met the primary endpoint.
The company said that the results showed an improvement in progression-free survival (PFS) with Calquence monotherapy compared to a combination of rituximab and idelalisib or bendamustine, and the safety and tolerability of Calquence was consistent with the known profile.
AstraZeneca executive vice-president of R&D Oncology 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.”
Ascend (ACE-CL-309) is the first of two Phase III CLL trials taken up by AstraZeneca under its development programme for Calquence. The second trial is Elevate-TN (ACE-CL-007) in treatment-naïve, front-line CLL.
Currently, Calquence is approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, UAE, and Qatar. It is being developed for the treatment of CLL and other blood cancers.
During the trial, 310 patients were randomised into two groups. The first group received Calquence monotherapy (100mg twice daily until disease progression), while patients in the second group received rituximab plus physician’s choice of idelalisib or bendamustine.
The primary endpoint is PFS, assessed by an independent review committee (IRC), while key 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 (TTNT).
The US Food and Drug Administration (FDA) granted approval for Calquence (acalabrutinib) in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy.
AstraZeneca and Acerta Pharma are evaluating Calquence in 26 clinical trials as part of an extensive clinical development programme.
Calquence is being developed for the treatment of multiple B-cell blood cancers.
Several Phase III clinical trials in CLL, including Ascend, Elevate-TN, Elevate-RR (ACE-CL-006), are being carried out to evaluate Calquence vs ibrutinib in previously-treated CLL, and ACE-CL-311 to assess Calquence in combination with venetoclax and obinutuzumab in previously-untreated fit patients with CLL.