AstraZeneca’s interim analysis of AMPLIFY trial statistically significant

Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca’s Calquence in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia. For the secondary endpoint of overall survival, a trend was observed in favour of Calquence in combination with venetoclax, with or without obinutuzumab, versus standard-of-care chemoimmunotherapy. The OS data were not mature at the time of this analysis and the trial will continue to assess OS as a key secondary endpoint. The safety and tolerability were consistent with the known safety profile of each medicine. No new safety signals were identified, with low rates of cardiac toxicity observed. The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.