12th Jun 2020 08:43
(Alliance News) - AstraZeneca PLC on Friday posted detailed results from two trials of its drug Calquence in chronic lymphocytic leukaemia patients, demonstrating the drug's long-term efficacy and tolerability.
Astra's phase 2 ACE-CL-001 trial and pivotal phase 3 Ascend trial both showed Calquence's efficacy and tolerability in chronic lymphocytic leukaemia, one of the most common types of leukaemia in adults.
In the ACE-CL-001 trial, 86% of patients treated with the drug as a first-line monotherapy were still taking it at the median follow up of more than four years. The overall response rate was 97%, with 7% of patients showing a complete response while 90% had a partial response.
In patient subgroups "with high-risk disease characteristics" the overall response rate was 100%. There were "no new long-term issues" from safety findings.
Final analysis of the Ascend trial found that around 82% of patients with relapse or refractory hronic lymphocytic leukaemia who had been treated with Calquence were still alive with no disease progression at 18 months. This compared to 48% of patients taking rituximab combined with idelalisib or bendamustine.
The Ascend trial has already met its primary endpoint, which is progression-free survival at interim analysis as assessed by an independent review committee.
Jose Baselga, executive vice president of Oncology R&D at Astra, said: "These long-term data reaffirm that Calquence delivers a durable response with a favourable safety profile for chronic lymphocytic leukaemia patients. Patients with chronic lymphocytic leukaemia are typically 70 years or older with comorbidities and often require treatment over a long time, making the sustained safety and efficacy profile highly relevant to their quality of life."
The results from ACE-CL-001 informed development of Astra's pivotal phase 3 Elevate TN trial which, along with Ascend, formed the basis of Calquence's approval in the US to treat chronic lymphocytic leukaemia or small lymphocytic lymphoma.
AstraZeneca shares were down 1.8% at 8,128.93 pence early Friday in London.
By Anna Farley; [email protected]
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