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Calquence PhIII ASCEND trial met primary endpoint
Calquence PhIII ASCEND trial met primary endpoint.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1192Y AstraZeneca PLC 07 May 2019 \n\n7 May 2019 07:00 BST\n \nCalquence Phase III ASCEND trial met primary endpoint at interim analysis\nin relapsed or refractory chronic lymphocytic leukaemia and will stop early\n \nCalquence significantly increased the time\npatients live without disease progression\n \nAstraZeneca today announced positive results from the Phase III ASCEND trial of Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL). Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Calquence monotherapy compared to a combination regimen of rituximab plus physician's choice of idelalisib or bendamustine. Importantly, the safety and tolerability of Calquence was consistent with the known profile.\n \nJosé Baselga, Executive Vice President, R&D Oncology 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.\"\n \nWithin AstraZeneca's robust development programme for Calquence, ASCEND is the first of two Phase III CLL trials expected to read out in 2019. The second is ELEVATE-TN (ACE-CL-007) in treatment-naïve, front-line CLL. Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, the UAE, and Qatar, and is being developed for the treatment of CLL and other blood cancers.\n \nAbout ASCEND\nASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously-treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two groups. Patients in the first group received Calquence monotherapy (100mg twice daily until disease progression). Patients in the second group received rituximab plus physician's choice of idelalisib or bendamustine.1\n \nThe primary endpoint is PFS assessed by an independent review committee (IRC), and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as...