AstraZeneca announced that the phase 2 CALAVI studies investigating the addition of Calquence (acalabrutinib) to best supportive care (BSC) in patients hospitalized with respiratory symptoms of COVID-19 failed to meet their primary efficacy endpoint. Results showed that the BTK inhibitor did not increase the proportion of patients who remained alive and free of respiratory failure.
José Baselga, executive vice president of oncology R&D at AstraZeneca, 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 hospitalized with respiratory symptoms of COVID-19.”
Results from a small study published earlier this year suggested that off-label use of Calquence in 19 patients having confirmed COVID-19 requiring hospitalization for hypoxaemia and evidence of inflammation, and/or lymphopenia led to “rapid improvements.” The findings showed that over a 10- to 14-day treatment course, Calquence “improved oxygenation in a majority of patients,” while measures of inflammation such as C-reactive protein and IL-6, “normalized quickly in most patients, as did lymphopenia, in correlation with improved oxygenation.”
Initiation of the CALAVI studies was announced in April, with two trials designed to evaluate the efficacy of Calquence with BSC versus BSC alone in patients hospitalized with respiratory complications of COVID-19, but who were not on mechanical ventilation and not in the intensive care unit. The primary endpoint measured respiratory failure or death.
Calquence is approved in certain markets, including the US, for the treatment of adults with chronic lymphocytic leukaemia and adults with mantle cell lymphoma who have received at least one prior therapy. The drug generated revenue of $145 million in the third quarter, with the “overwhelming majority” of sales in the US.