AstraZeneca upbeat on latest 'Calquence' trial data
By Josh White
Date: Monday 17 Jun 2019
(Sharecast News) - AstraZeneca announced detailed results from the interim analysis of the phase 3 'ASCEND' trial on Monday, showing Calquence (acalabrutinib) significantly prolonged the time patients lived without disease progression in relapsed or refractory chronic lymphocytic leukaemia (CLL).
The FTSE 100 pharmaceuticals giant said the ASCEND trial compared Calquence with the physician's choice of rituximab combined with idelalisib (IdR) or bendamustine (BR), in patients with relapsed or refractory CLL.
It explained that, at a median follow-up of 16.1 months, results showed a "statistically-significant and clinically-meaningful" improvement in progression-free survival for patients treated with Calquence compared to IdR or BR, reducing the risk of disease progression or death by 69%.
The median time without disease progression for patients treated with Calquence had not yet been reached, compared to 16.5 months in the control arm.
At 12 months, 88% of patients on Calquence showed no disease progression compared to 68% for the control arm.
"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," said AstraZeneca's executive vice-president of oncology research and development José Baselga.
"These data, along with our recent positive results from the phase 3 ELEVATE-TN trial in previously-untreated chronic lymphocytic leukaemia, will serve as the foundation for regulatory submissions later this year."
Paolo Ghia, professor of medical oncology at Università Vita-Salute San Raffaele in Milan, and investigator of the ASCEND trial, added that it was the first randomised trial to directly compare a BTK inhibitor as monotherapy with standard chemoimmunotherapy or idelalisib and rituximab combinations.
"With a significant improvement in progression-free survival and a favourable safety profile, acalabrutinib may become an important choice for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia," Dr Ghia explained.
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