AstraZeneca PLC on Monday said a study showed a leukaemia treatment significantly improved progression-free survival in patients with chronic lymphocytic leukaemia.
The Cambridge-based pharmaceuticals firm said the positive high-level results came from an interim analysis of the Amplify Phase III trial.
This showed a fixed duration of AstraZeneca’s Calquence in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia.
Calquence is a second-generation, selective inhibitor of Bruton’s tyrosine kinase.
It is approved for the treatment of CLL and small lymphocytic lymphoma in the US and Japan, approved for CLL in the EU, and approved in China for relapsed or refractory CLL and SLL.
Calquence is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, mantle cell lymphoma and diffuse large B-cell lymphoma.
Susan Galbraith, executive vice president, Oncology R&D, said the results demonstrate the potential of including a BTK inhibitor in a fixed-duration regimen.
‘If approved, Calquence would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers,’ she noted.
AstraZeneca said the safety and tolerability were consistent with the known safety profile of each medicine. No new safety signals were identified.
Shares in AstraZeneca rose 1.0% to 12,302.00 pence on Monday morning in London.
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