An interim analysis of the AMPLIFY Phase III trial has revealed encouraging results in the treatment of chronic lymphocytic leukemia (CLL) with AstraZeneca’s CALQUENCE® (acalabrutinib).
The combination of CALQUENCE with venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) compared to standard chemotherapy in previously untreated patients.
Although the data for overall survival (OS) was not fully mature, a positive trend was observed favoring the CALQUENCE combination. The trial will continue to assess OS as a secondary endpoint.
The fixed duration of the CALQUENCE combination offers several benefits for patients. It allows for treatment breaks, reducing the risk of long-term adverse effects and drug resistance. This approach also improves quality of life for those living with this chronic disease.
The AMPLIFY results indicate the potential of including a BTK inhibitor like CALQUENCE in a fixed-duration regimen for CLL. This represents progress in the field and provides more options for patients and healthcare providers.
The safety and tolerability of the CALQUENCE combination were consistent with the known profiles of each individual medication. No new safety concerns were identified, and cardiac toxicity rates were low.
The AMPLIFY data will be presented at an upcoming medical meeting and submitted to regulatory authorities for further review. CALQUENCE has the potential to become the only second-generation BTK inhibitor available for both treat-to-progression and fixed-duration treatment, offering expanded treatment options for CLL patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
