AstraZeneca to pit blood cancer drug Calquence against COVID-19 with the company’s fastest-ever trial launch
pharmafile | April 14, 2020 | News story | Manufacturing and Production, Research and Development | AstraZeneca, COVID-19, Calquence, coronavirus, pharma
As the R&D race against COVID-19 continues, AstraZeneca is poised to launch a global, multicentre clinical trial to test its approved blood cancer drug Calquence (acalabrutinib) in the treatment of exaggerated immune response, also known as a cytokine storm, in patients severely ill with life-threatening COVID-19 symptoms, with the goal of ultimately reducing mortality and necessity of assisted ventilation.
When added to Calquence has shown benefit in early-stage clinical trials in reducing the severity of COVID-19 respiratory distress, reducing inflammation through inhibiting the Bruton’s tyrosine kinase (BTK) pathway, which strong scientific evidence suggests is implicated in the production of inflammatory cytokines.
The study was designed on the back of this clinical base and will feature two parts. In the first, Calquence plus best supportive care (BSC) will be assessed in hospitalised patients who are not in an intensive care unit (ICU) compared to BSC alone; the second part will evaluate the combo’s efficacy in IC patients. The launch of the study is the fastest “of any clinical trial in the history of AstraZeneca”, the company’s Executive Vice President of Oncology R&D, Jose Baselga, said.
Dr Louis M Staudt, Chief of the Lymphoid Malignancies Branch at the National Cancer Institute (NCI), said of the study: “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.”
The trial will be accepting participants in the US and European countries in the coming days, AZ confirmed.
Matt Fellows
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