AstraZeneca to Study BTK Inhibitor Calquence as Treatment for Cytokine Storm Associated With COVID-19 Infection

AstraZeneca announced that it will investigate the potential of the BTK inhibitor Calquence (acalabrutinib) in the treatment of the cytokine storm associated with COVID-19 infection in severely ill patients. The company noted that the design of the CALAVI study is based on “strong scientific evidence” supporting the role of the BTK pathway in the production of inflammatory cytokines.

According to the drugmaker, early clinical data have shown that a decrease in inflammation caused by BTK inhibition appears to reduce the severity of COVID-19-induced respiratory distress. The main goal of the CALAVI trial is to see if the addition of Calquence to best supportive care (BSC) can reduce mortality and the need for assisted ventilation in patients with life-threatening COVID-19 symptoms.

The first part of the randomized study will evaluate the addition of Calquence to BSC versus BSC alone in patients hospitalized with COVID-19 who are not in the intensive care unit (ICU), while the second part will investigate the addition of the BTK inhibitor to BSC in a cohort of patients in the ICU. The trial is expected to open for enrollment in the coming days in the US and several countries in Europe.

“With this trial we…hope to demonstrate that adding Calquence to best supportive care reduces the need to place patients on ventilators and improves their chances of survival,” remarked José Baselga, executive vice president of oncology R&D at AstraZeneca. The executive indicated that “this is the fastest launch of any clinical trial in the history of AstraZeneca.”

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.