AstraZeneca reports ‘positive’ results from AMPLIFY Phase 3 trial

“Positive” results from the AMPLIFY Phase III trial showed AstraZeneca’s (AZN) Calquence in combination with venetoclax 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, AstraZeneca announced. These results will be presented at the American Society of Hematology 2024 Annual Meeting in San Diego, CA. At a median follow up of 41 months, results showed Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to standard-of-care chemoimmunotherapy. Calquence plus venetoclax with obinutuzumab demonstrated a 58% reduction in the risk of disease progression or death compared to standard-of-care chemoimmunotherapy. Median PFS was not reached for either experimental arm versus median PFS of 47.6 months for chemoimmunotherapy. Interim overall survival data demonstrated a favourable trend which was nominally statistically significant for Calquence plus venetoclax, however the OS data were immature at the time of this analysis and the trial will continue to assess OS as a key secondary endpoint. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Based on these impressive data from the AMPLIFY trial, Calquence is the only second-generation BTK inhibitor to demonstrate efficacy in the front-line treatment of patients with chronic lymphocytic leukaemia as both a treat-to-progression and a fixed-duration approach. This advance is an important development for patients and their physicians who seek new options and more flexibility in managing this disease in the long term.”