The European Union (EU) has granted approval to AstraZeneca’s Calquence-based regimens for the treatment of previously untreated chronic lymphocytic leukaemia (CLL) in adults. The endorsement comes on the heels of impressive results from the AMPLIFY Phase III trial, which underscored the efficacy of these novel treatments in CLL management.
Calquence, medically known as acalabrutinib, is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). It functions by covalently binding to BTK, thereby inhibiting its activity. In B-cells, which are a type of white blood cell, BTK signalling activates pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. By inhibiting these pathways, Calquence curtails the growth and spread of cancerous cells.
The AMPLIFY trial, whose results were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine, investigated the use of Calquence in combination with venetoclax, with or without obinutuzumab. The results showed that 77% of patients treated with Calquence plus venetoclax and 83% of patients treated with Calquence plus venetoclax with obinutuzumab were progression-free at three years. This is compared to a 67% progression-free rate for patients who received standard-of-care chemoimmunotherapy.
Moreover, the median progression-free survival (PFS) rate was not reached for either experimental arm, compared to 47.6 months for chemoimmunotherapy. More impressively, the Calquence plus venetoclax regimen reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy, while the combination of Calquence, venetoclax, and obinutuzumab resulted in a 58% reduction.
These findings point to a significant reduction in the risk of disease progression or death with Calquence-based regimens, offering a promising new therapeutic avenue for CLL patients. CLL is the most common type of leukaemia in adults, with an estimated 27,000 people diagnosed in the UK, France, Germany, Spain, and Italy in 2024 alone.
Dr. Barbara Eichhorst, from the University Hospital Cologne in Germany and an investigator for the AMPLIFY trial, said: “For patients diagnosed with chronic lymphocytic leukaemia, this approval provides a new option in the first-line setting that may help to minimize long-term side effects and reduce drug resistance as they may occur with continuous treatment. A fixed-duration regimen is appealing to patients and helps with adherence during the treatment period.”
As a venture-backed synthetic biology startup, we recognize the importance of such advancements in the field. The success of the Calquence-based regimens may pave the way for a shift towards more effective and targeted therapies in CLL management, and bodes well for the future of personalized medicine in oncology.
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