Phase III ELEVATE-TN trial of Calquence meets endpoint in chronic lymphocytic leukaemia

AstraZeneca announced positive results from the Phase III ELEVATE-TN trial of Calquence (acalabrutinib) in patients with previously-untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults. This is the second Calquence pivotal trial in CLL to meet its primary endpoint early, following the positive results of the ASCEND trial, announced in May. The trial met its primary endpoint; Calquence in combination with obinutuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.

The trial also met a key secondary endpoint showing Calquence monotherapy achieved a statistically-significant and clinically-meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen. The safety and tolerability of Calquence was consistent with its established profile. AstraZeneca plans to present detailed results from ELEVATE-TN at a forthcoming medical meeting.

Comment: Calquence (acalabrutinib) was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.