AstraZeneca declares positive data from chronic lymphocytic leukaemia therapy trial

AstraZeneca's Phase III AMPLIFY trial has reported positive results for Calquence (acalabrutinib) in treating chronic lymphocytic leukemia (CLL). This global, open-label study evaluated Calquence, used with venetoclax and optionally obinutuzumab, versus standard chemoimmunotherapy in previously untreated adults without del(17p) or TP53 mutations.

Participants were randomized to receive either the Calquence regimen or standard treatment. The trial's primary endpoint was progression-free survival (PFS), with investigator-assessed PFS as a key secondary endpoint. Additional secondary endpoints included overall survival (OS), event-free survival, overall response rate, duration of response, and time to next treatment.

Results showed a significant and clinically meaningful improvement in PFS with the Calquence regimen. While OS data indicated a favorable trend, it was not yet mature. The safety profile of Calquence was consistent with existing data, with no new safety concerns identified.