AstraZeneca announced that its Calquence (acalabrutinib) has failed to meet the primary efficacy endpoint in the CALAVI phase II trials, which evaluated patients hospitalised with respiratory symptoms of Covid-19.
The addition of Calquence to best supportive care (BSC) has failed to increase the proportion of patients who remained alive and free of respiratory failure.
Calquence, the next-generation and selective inhibitor of Bruton’s tyrosine kinase (BTK), binds covalently to BTK to inhibit its activity.
The CALAVI phase II programme included two randomised, open-label and multicentre trials designed to assess the efficacy and safety of Calquence with BSC versus BSC alone in patients hospitalised with respiratory complications of Covid-19.
AstraZeneca has randomised patients in 1:1 ratio in the trials and assessed the addition of Calquence to current BSC in patients who were hospitalised but not on mechanical ventilation and not in the intensive care unit.
According to the company, the primary endpoint measured respiratory failure or death and the trials have been conducted in the US and in multiple other countries.
AstraZeneca oncology R&D executive vice president José Baselga said: “The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of Covid-19.
“While the CALAVI results are disappointing, we remain committed to advancing science that helps patients during this unprecedented global pandemic, including clinical trials for the AstraZeneca Oxford coronavirus vaccine and our long-acting antibody combination.”
AstraZeneca and Acerta Pharma are currently assessing Calquence in over 20 company-sponsored clinical trials, as part of an extensive clinical development programme.
Calquence is being developed to treat multiple B-cell blood cancers such as chronic lymphocytic leukaemia, mantle cell lymphoma, diffuse large B-cell lymphoma, Waldenström’s macroglobulinaemia, follicular lymphoma, and other haematologic malignancies.
In August, AstraZeneca initiated a phase 1 trial of a monoclonal antibody combination called AZD7442, which is being developed for the prevention and treatment of Covid-19.