Calquence showed promising clinical improvement in majority of 19 hospitalised COVID-19 patients .- AstraZeneca

Results published in Science Immunology showed that Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease. The peer-reviewed case series of 19 hospitalised patients with COVID-19 disease and severe hypoxia and/or inflammation is a collaboration from investigators across the US, including AstraZeneca scientists, and led by Wyndham Wilson, M.D., Ph.D. and Louis Staudt, M.D., Ph.D. at the National Cancer Institute of the National Institutes of Health in the US.

The publication describes the effects of Calquence administration in patients with severe respiratory illness caused by the SARS-CoV-2 virus. A virus-induced hyperimmune response or “cytokine storm” is hypothesised to be a major pathogenic mechanism of respiratory illness in these patients, and evidence suggests that dysregulated BTK-dependent lung macrophage signalling mediates this cytokine storm and plays a role in COVID-19 pneumonia.

Calquence is a next-generation, selective BTK inhibitor currently approved in the US for the treatment of certain haematological malignancies.8-10 Calquence is not currently approved in any country to treat patients with illnesses related to SARS-CoV-2.

CALAVI: The CALAVI programme comprises two randomised, open-label, multicentre, global trials evaluating the efficacy and safety of Calquence with best supportive care (BSC) versus BSC alone in patients hospitalised with respiratory complications of COVID-19. These trials are evaluating the addition of Calquence to current BSC in patients who are hospitalised but not on assisted ventilation. These trials are being conducted around the world: one trial in the US and one trial ex-US including Europe, Japan and South America. The primary efficacy endpoint measures the number of patients alive and free of respiratory failure following treatment.

See- Roschewski M, et al. “Inhibition of Bruton tyrosine kinase in patients with severe COVID-19.” Sci Immunol. 2020;5(28). DOI: 10.1126/sciimmunol.abd0110..