(Alliance News) - AstraZeneca on Saturday posted positive results from its phase 3 Elevate TN trial of Calquence plus obinutuzumab in leukaemia.
The trial found that 93% of previously untreated chronic lymphocytic leukaemia patients taking Calquence, plus the cancer drug obinutuzumab, remained free of disease progression or death at 24 months. This compares to just 47% of patients taking the standard treatment of chlorambucil plus obinutuzumab.
Furthermore, the trial found that 87% of patients taking Calquence alone were free of disease progression or death at the 24 month mark.
Calquence's safety and tolerability in the study was consistent with the known profile of the drug. Adverse events resulted in treatment being discontinued in 11% of patients taking Calquence plus obinutuzumab, versus 8.9% in Calquence alone and 14% in chlorambucil plus obinutuzumab.
Jose Baselga, executive vice president of Oncology Research & 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. These results also provide, for the first time, post-hoc analysis data exploring the potential progression-free survival benefit of adding obinutuzumab to a BTK inhibitor such as Calquence versus BTK inhibitor monotherapy in a randomised trial."
Calquence is already approved in the US and Australia for adults with chronic lymphocytic leukaemia or small lymphocytic lymphoma and in Canada for chronic lymphocytic leukaemia. It is also approves in a number of countries, including the US and India, for adult patients with mantle cell lymphoma who have received at least one prior therapy.
By Anna Farley; annafarley@alliancenews.com
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