▎WuXiEdited by Kant Content Team

AstraZeneca recently announced positive results from the Phase 3 clinical trial AMPLIFY. Analysis shows that the combination of its Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) with venetoclax demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia (CLL). Detailed study results were presented at the 2024 American Society of Hematology (ASH) Annual Meeting.

Analysis shows that the median follow-up41At months, compared with the standard-freeCompared with epidemic chemotherapy,acalabrutinibUnitedvenetoclaxReduced the risk of disease progression or death35%（HR=0.65；95% CI：0.49-0.87；p=0.0038）。In addition,Compared with standard immunochemotherapy，acalabrutinibUnitedvenetoclaxAndobinutuzumabReduced the risk of disease progression or death in patients by58%（HR=0.42；95% CI：0.30-0.59；p<0.0001）。Median of patients receiving standard chemotherapy and immunotherapyPFSFor47.6months, and two typesacalabrutinibPatients in the treatment group did not reach the median.PFS。

Although the key secondary endpoint of overall survival (OS) is not yet mature, the analysis shows,Acalabrutinib in combination with venetoclax demonstrated significant survival benefits compared to standard chemoimmunotherapy (HR=0.33; 95% CI: 0.18-0.56; p<0.0001).

▲Summary of Efficacy Results from the AMPLIFY Trial (Image Source: Reference [1])

Two typesacalabrutinibThe durability of the treatment group's efficacy is remarkable,acalabrutinibUnitedvenetoclaxWith and WithoutobinutuzumabGroup of patients36The progression-free survival rates at months were respectively83.1%And76.5%, this value in patients receiving standard immunochemotherapy was66.5%。In addition, the patient showed significant relief,acalabrutinibUnitedvenetoclaxThe overall response rate (ORR) for92.8%, and addObinutuzumab Triple TherapyGroup as92.7%, andImmunotherapyGroup as75.2%。

In terms of safety, acalabrutinib was well-tolerated, consistent with its known safety profile, and no new safety signals were identified. The incidence of grade 3 or higher adverse events (AEs) was: 53.6% in the acalabrutinib plus venetoclax group, 69.4% in the acalabrutinib plus obinutuzumab group, and 60.6% in the standard chemoimmunotherapy group.

AcalabrutinibIs a second-generation selectiveBTKInhibitor, effectively inhibits BTK through covalent bindingInhibit its activity.In B cells, the activation of the BTK signaling pathway can promote key biological processes such as proliferation, migration, chemotaxis, and adhesion.The drugHas been approved in the United States, China, and multiple other countries and regions for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

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References:

[1] Fixed-duration Calquence plus venetoclax demonstrated superior progression-free survival vs. standard of care in previously untreated chronic lymphocytic leukaemia, with 77% of patients progression free at three years in AMPLIFY Phase III trial. Retrieved December 9, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/fixed-duration-calquence-plus-venetoclax-demonstrated-superior-pfs-vs-standard-care-previously-untreated-cll-with-77-of-patients-progression-free-3-years-amplify-phase-iii-trial.html

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