AstraZeneca has presented detailed data showing that Calquence (acalabrutinib) significantly prolonged progression free survival (PFS) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL).
According to an interim analysis of the Phase III ASCEND trial, showcased at the European Haematology Association (EHA) Annual Congress in Amsterdam, there was a “statistically-significant and clinically-meaningful improvement” in PFS for patients treated with Calquence versus standard chemoimmunotherapy or idelalisib and rituximab combinations at at a median follow-up of 16.1 months, reducing the risk of disease progression or death by 69%.
The drug giant also noted that median time without disease progression for patients treated with Calquence has not yet been reached versus 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.
Also of note, the safety and tolerability of the drug was consistent with its established profile.
According to José Baselga, executive vice president, Oncology R&D, at AZ, the 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.”
He also confirmed that the results will, together with recent data from the Phase III ELEVATE-TN trial in previously-untreated chronic lymphocytic leukaemia, “serve as the foundation for regulatory submissions later this year”.
“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,” added Paolo Ghia, professor, Medical Oncology, Università Vita-Salute San Raffaele in Milan, and investigator of the ASCEND trial.
Calquence was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adults with MCL who have received at least one prior therapy.