CHMP Recommends AstraZeneca's Calquence for Chronic Lymphocytic Leukemia

AstraZeneca (AZ) has taken a significant step forward with its cancer treatment, Calquence (acalabrutinib), as it receives a favorable nod from the European Medicines Agency's human medicines committee. The Committee for Medicinal Products for Human Use (CHMP) has endorsed the use of a fixed-duration regimen of Calquence, in combination with venetoclax, with or without obinutuzumab, specifically for adults who have not undergone previous treatment for chronic lymphocytic leukaemia (CLL).

The CHMP's recommendation is grounded in robust data from the phase 3 AMPLIFY trial. The study illustrated that the combination of Calquence with venetoclax, and with obinutuzumab, significantly lowered the risk of disease progression or mortality. Specifically, the risk was reduced by 35% when Calquence was used with venetoclax, and by 58% when combined with both venetoclax and obinutuzumab, in comparison to the traditional chemoimmunotherapy standard of care.

Over a three-year span, the trial showed promising results: 77% of patients treated with Calquence plus venetoclax, and 83% receiving the addition of obinutuzumab, remained free of disease progression. This is in contrast to a 67% progression-free rate seen in patients receiving standard chemoimmunotherapy. Furthermore, the median progression-free survival had not been reached for patients in either of the Calquence treatment groups, whereas it was 47.6 months for those on chemoimmunotherapy.

Chronic lymphocytic leukaemia, while deemed incurable, is the most prevalent form of leukaemia among adults, with an estimated 27,000 new cases reported across the UK, France, Germany, Spain, and Italy in 2024. Those diagnosed often live with the disease for extended periods, necessitating prolonged treatment regimens that can lead to long-term side effects.

Calquence operates by inhibiting the function of the Bruton’s tyrosine kinase (BTK) protein, which plays a crucial role in the proliferation of malignant B cells in CLL patients. Already approved for certain CLL cases in Europe, the fixed-duration treatment strategy is designed to mitigate the potential for adverse effects and drug resistance, by introducing periods where patients are off medication.

Susan Galbraith, AZ's executive vice president for oncology haematology research and development, expressed optimism about the latest recommendation. She highlighted that Calquence paired with venetoclax could become the sole all-oral second-generation BTK inhibitor available in Europe for patients who have not been previously treated for CLL. The flexibility offered by Calquence's efficacy and safety in both fixed-duration and treat-to-progression regimens provides more choices for patients and their healthcare providers.

The European Commission is set to evaluate the CHMP's recommendation further, as it deliberates over Calquence's approval for this particular indication. The outcome could potentially broaden the available treatment options for individuals battling previously untreated chronic lymphocytic leukaemia, ushering in a new era of therapeutic possibilities.