AstraZeneca reported the phase 3 ELEVATE-TN trial, evaluating Calquence (acalabrutinib) for patients with previously untreated chronic lymphocytic leukemia, met the primary endpoint early. This follows the positive results of the ASCEND trial, announced in May, which met the same endpoint in the same patient population.
ELEVATE-TN (ACE-CL-007) is a randomized, multicenter, open-label Phase III trial evaluating the safety and efficacy of Calquence alone or in combination with obinutuzumab vs. chlorambucil in combination with obinutuzumab in previously untreated patients with CLL. In the trial, 535 patients were randomized (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression). The primary endpoint is Progression Free Survival (PFS) in the Calquence 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 Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Both endpoints showed statistically significant and clinically meaningful improvements.
AstraZeneca plans to present detailed results from ELEVATE-TN at a forthcoming medical meeting. The results from the ASCEND and ELEVATE-TN trials will be used as the basis for regulatory submissions later this year.
About Chronic lymphocytic leukemia
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults, with an estimated 191,000 new cases globally and 20,720 new cases in the US annually, and prevalence that is expected to grow with improved treatment. In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets. This could result in anemia, infection and bleeding. B-cell receptor signaling through BTK is the of the essential growth pathways for CLL.
About Calquence (acalabrutinib)
Calquence is an inhibitor of Bruton tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
Calquence was granted accelerated approval by the US FDA in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy.