ELEVATE-TN trial: Acalabrutinib alone or in combination has significantly increased the time patients lived without disease progression
Results from the phase III ELEVATE-TN trial of Acalabrutinib ( Calquence ) in patients with previously-untreated chronic lymphocytic leukaemia ( CLL ), the most common type of leukaemia in adults, were presented.
The trial met its primary endpoint; Acalabrutinib in combination with Obinutuzumab ( Gazyva; Gazyvaro ) 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 Acalabrutinib monotherapy achieved a statistically-significant and clinically-meaningful improvement in PFS compared to the chemotherapy and Obinutuzumab regimen.
The safety and tolerability of Acalabrutinib was consistent with its established profile.
ELEVATE-TN is a randomised, multicentre, open-label phase III trial evaluating the safety and efficacy of Acalabrutinib alone or in combination with Obinutuzumab versus Chlorambucil in combination with Obinutuzumab in previously-untreated patients with CLL.
In the trial, 535 patients were randomised ( 1:1:1 ) into three arms. Patients in the first arm received chlorambucil in combination with Obinutuzumab.
Patients in the second arm received Acalabrutinib ( 100mg twice daily until disease progression ) in combination with Obinutuzumab.
Patients in the third arm received Acalabrutinib monotherapy ( 100mg twice daily until disease progression ).
The primary endpoint is PFS in the Acalabrutinib and Obinutuzumab arm compared to the Chlorambucil and Obinutuzumab arm, assessed by an independent review committee ( IRC ), and a key secondary endpoint is IRC-assessed PFS in the Acalabrutinib monotherapy arm compared to the Chlorambucil and Obinutuzumab arm.
Other secondary endpoints include objective response rate, time to next treatment and overall survival.
Acalabrutinib is an inhibitor of Bruton tyrosine kinase ( BTK ). It binds covalently to BTK, thereby inhibiting its activity.
In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. ( Xagena )
Source: AstraZeneca, 2019