AstraZeneca’s Calquence combo promising in chronic lymphocytic leukaemia

AstraZeneca (AZ) recently announced promising results from its phase 3 AMPLIFY trial evaluating Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, for treating chronic lymphocytic leukemia (CLL). The study focused on combining Calquence with venetoclax, with or without obinutuzumab, and compared these combinations to standard chemoimmunotherapy in adults newly diagnosed with CLL.

The interim analysis revealed that the Calquence combinations significantly improved progression-free survival (PFS) compared to traditional chemoimmunotherapy, showing both statistical significance and clinical relevance. Additionally, there was a favorable trend for overall survival (OS) as a secondary endpoint, though the data for OS was not yet mature. The trial will continue to further evaluate this aspect.

CLL stands as the most commonly diagnosed leukaemia in adults worldwide, with about 4,000 new cases annually in the UK alone. While CLL is considered incurable, patients often live for many years with the condition, necessitating ongoing treatment.

Susan Galbraith, AZ's executive vice president of oncology research and development, highlighted the significance of the findings, stating they showcase the potential benefits of incorporating a BTK inhibitor into a fixed-duration treatment regimen. Principal investigator Jennifer Brown from Dana-Farber Cancer Institute and Harvard Medical School emphasized the importance of fixed-duration regimens, noting that they allow patients with CLL to take treatment breaks. This approach could reduce the risk of long-term adverse effects and drug resistance, ultimately enhancing patients' quality of life.

Calquence is already approved for certain CLL cases in Europe, the US, and several other countries. If it secures approval based on these new findings, Calquence would become the only second-generation BTK inhibitor available for both treat-to-progression and fixed-duration treatments, offering more flexibility and options for patients and their healthcare providers.

AZ plans to present the trial data at an upcoming medical meeting and will share the results with global regulatory bodies. In addition to its use in CLL, Calquence is also approved for treating small lymphocytic lymphoma and mantle cell lymphoma (MCL). Last month, AZ reported positive outcomes for Calquence combined with standard chemoimmunotherapy (bendamustine and rituximab) in adults with previously untreated MCL. This combination reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy alone, with median PFS for the Calquence combination at 66.4 months versus 49.6 months for the chemoimmunotherapy group.

In conclusion, the recent results from the AMPLIFY trial underscore Calquence's potential to significantly improve the treatment landscape for CLL by offering more durable and flexible treatment options. The positive findings in MCL further highlight the drug's efficacy across multiple types of lymphoma, marking an important advancement in oncology treatments.

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