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(Alliance News) - AstraZeneca PLC on Saturday said its drug Calquence significantly prolonged the time patients lived without disease progression in chronic lymphocytic leukaemia.
The drug maker's phase three Ascend trial found 88% of patients with relapsed or refractory chronic lymphocytic leukaemia - the most common type of leukaemia in adults - who took Calquence had no disease progression after 12 months. This compared to 68% in the control arm.
At a median follow-up of 16.1 months, the trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in patients taking Calquence versus control, with the risk of disease progression or death reduced by 69%.
The median time with no disease progression in Calquence patients has not yet been reached in the study, versus 16.5 months in the control.
Jose Baselga, executive vice president of Oncology Research & Development at Astra said: "These data add to the growing body of evidence to support the profile of Calquence as a selective BTK inhibitor that offers a chemotherapy-free treatment option with a favourable safety profile in chronic lymphocytic leukaemia, a life-threatening disease. These data, along with our recent positive results from the Phase III Elevate-TN trial in previously-untreated chronic lymphocytic leukaemia, will serve as the foundation for regulatory submissions later this year."
Calquence has already been approved in the US to treat adult patients with mantle cell lymphoma who have received a prior therapy.
