AstraZeneca has reported positive interim results from the Phase III ELEVATE-TN trial evaluating Calquence (acalabrutinib) for previously untreated chronic lymphocytic leukaemia (CLL).
The trial met its primary endpoint of progression-free survival (PFS) improvement in patients treated with Calquence, compared to those on the chemotherapy based chlorambucil and obinutuzumab combination.
The trial also met a key secondary endpoint that saw improved PFS in patients treated with Calquence monotherapy compared to a chemotherapy plus obinutuzumab combination.
The safety and tolerability of Calquence during the ELEVATE-TN trial was observed to be consistent with its established profile.
This is the second Phase III trial to yield positive results for the drug, after the Phase III Ascend trial met its primary endpoint of improvement in PFS with Calquence monotherapy, compared to a combination of rituximab and idelalisib or bendamustine.
AstraZeneca oncology research and development (R&D) executive vice-president José Baselga said: “These findings confirm the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia.
“The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.”
Calquence is a Bruton tyrosine kinase (BTK) inhibitor being developed to treat a variety of B-cell blood cancers such as CLL. Currently, it has approval for relapsed or refractory mantle cell lymphoma (MCL).
The randomised, multi-centre, open-label ELEVATE-TN trial investigated the drug’s safety and efficacy in a total of 535 patients.
In addition to PFS, the trial has been designed to track objective response rate, time to next treatment and overall survival.