AstraZeneca’s trial of leukaemia drug Calquence yields positive results
pharmafile | December 9, 2019 | News story | Sales and Marketing | AstraZeneca, Calquence, leukaemia, phase 3
AstraZeneca confirmed it had recorded positive results from its Phase 3 trial of Calquence plus obinutuzumab in leukaemia.
The trial results showed that 93% of previously untreated chronic lymphocytic leukaemia patients taking Calquence and the cancer drug obinutuzumab, remained free of disease progression or death at 24 months. It also found that 87% of patients just taking Calquence had a similar experience.
This is in contrast to just 47% of patients taking the standard treatment of chlorambucil plus obinutuzumab remaining free of disease progression or death following the same period.
The safety and tolerability of Calquence was consistent with the known profile of the drug. Results in the study showed that 11% of patients taking Calquence plus obinutuzumab experienced adverse events resulting in treatment being discontinued. In Calquence alone it was 8.9%, while in patients taking chlorambucil plus obinutuzumab it was 14%.
Last month the FDA approved Calquence for adults in the US if they have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma. It is also approved for these two types of diseases in Australia while Canada allows its use for CLL.
Jose Baselga, Executive Vice President of Oncology Research and Development, said: “On the heels of approvals in the US, Australia and Canada, these full results provide further evidence that Calquence, as a new treatment option for patients with chronic lymphocytic leukaemia, demonstrates remarkable efficacy and a favourable tolerability profile.”
AstraZeneca gained rights to Calquence at the end of 2015 as part of a $4 billion deal which gave them a majority share in Acerta Pharma.
Conor Kavanagh
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