AstraZeneca’s Calquence Combination Shows Promise in Chronic Lymphocytic Leukemia with Fixed-Duration Regimens

Fixed-Duration Treatment:
AstraZeneca's Calquence (acalabrutinib) in combination with venetoclax (Venclexta) and optionally obinutuzumab (Gazyva) has shown significant improvement in progression-free survival (PFS) in patients with treatment-naive chronic lymphocytic leukemia (CLL) in the Phase III AMPLIFY trial1 2 4.

Clinical Significance:
The trial demonstrated a statistically significant and clinically meaningful improvement in PFS compared to standard-of-care chemoimmunotherapy, with a favorable trend in overall survival (OS)1 2 4.

Safety Profile:
The safety and tolerability of the combination were consistent with the known safety profiles of each drug, with no new safety signals identified and low rates of cardiac toxicity observed1 2 4.

Regulatory Implications:
If approved, Calquence would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, offering more options for patients and healthcare providers1 2 4.

Patient Benefits:
Fixed-duration regimens could allow patients to take breaks from treatment, reducing the risk of long-term adverse events and drug resistance, and improving quality of life1 2 5.

Economic Impact:
Fixed-duration regimens may also help limit CLL treatment costs, which could be beneficial for payers and patients5.

Sources:

1. https://www.biospace.com/drug-development/astrazenecas-calquence-aces-phase-iii-cll-trial-eyes-fixed-duration-approval

2. https://www.onclive.com/view/fixed-duration-acalabrutinib-venetoclax-combo-improves-pfs-in-frontline-cll

4. https://www.astrazeneca.com/media-centre/press-releases/2024/calquence-fixed-duration-combo-improved-1l-cll-pfs.html

5. https://www.ajmc.com/view/fixed-duration-acalabrutinib-plus-venetoclax-beats-chemoimmunotherapy-in-first-line-cll-adding-obinutuzumab-boosts-pfs

Sources:

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