AstraZeneca begins clinical trial of blood cancer drug Calquence for Covid-19 patients
AstraZeneca is beginning a global clinical trial to assess the potential of a blood cancer drug to help severely ill Covid-19 patients.
Encouraging early clinical data suggests Calquence (acalabrutinib) could play a role in decreasing inflammation and reducing the severity of Covid-19 induced respiratory distress.
Calquence is a highly selective inhibitor of the Bruton’s tyrosine kinase (BTK) and there is strong scientific evidence that the BTK pathway is involved in the production of inflammatory cytokines.
The trial, called CALAVI, will assess if the drug can be used to treat the exaggerated immune response, known as a cytokine storm, associated with Covid-19 infection in severely ill patients.
José Baselga, executive vice president, oncology R&D, said: “With this trial we are responding to the novel insights of the scientific community and hope to demonstrate that adding Calquence to best supportive care reduces the need to place patients on ventilators and improves their chances of survival. This is the fastest launch of any clinical trial in the history of AstraZeneca.”
The large multicentre, global, randomised trial uses a two-part patient-centric design to accelerate data capture and analysis.
Part one is evaluating the addition of Calquence to best supportive care (BSC) versus BSC alone in patients hospitalised with Covid-19 who are not in an intensive care unit (ICU).
Part two evaluates the addition of Calquence to BSC in a cohort of patients within ICU.
Dr Louis M Staudt, chief of the Lymphoid Malignancies Branch at the National Cancer Institute, said: “Given the well-documented role of the protein BTK in regulating inflammation, it is possible that inhibiting BTK with acalabrutinib could provide clinical benefit in patients with advanced Covid-19 lung disease.
“As with all new treatments, it will be necessary to gather data from clinical trials in order to understand the best and safest treatment options for patients.”
Cambridge-based AstraZeneca said the CALAVI trial is opening for enrolment in the US and several countries in Europe.
The company is also working on new antibody therapies, which it hopes to trial in three to five months.