AstraZeneca’s Calquence Achieves Significant Progression-Free Survival in Phase III CLL Trial, Eyes Fixed-Duration Approval

1. Positive Phase III Results: AstraZeneca's Calquence (acalabrutinib) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia (CLL) in the AMPLIFY Phase III trial.
2. Fixed-Duration Treatment: The trial evaluated Calquence in combination with venetoclax, with or without obinutuzumab, as a fixed-duration treatment, allowing patients to take breaks from treatment and potentially improving quality of life.
3. Overall Survival Trend: A favorable trend was observed in overall survival (OS) for the Calquence-based regimen, although the OS data were not yet mature at the time of the analysis.
4. Safety Profile: The safety and tolerability of Calquence were consistent with its known safety profile, with no new safety signals identified and low rates of cardiac toxicity observed.
5. Global Regulatory Submissions: The data from the AMPLIFY trial will be presented at a forthcoming medical meeting and shared with global regulatory authorities, with the potential for Calquence to become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment.