Calquence has reduced inflammation and improved clinical outcomes in 19 hospitalised patients with Covid-19 disease and severe hypoxia or inflammation

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AstraZeneca reports positive outcomes for Calquence in hospitalised Covid-19 patients. (Credit: mattthewafflecat from Pixabay.)

In a recent study series, Calquence (acalabrutinib) has reduced inflammation and improved clinical outcomes in patients with severe Covid-19 disease.

US researchers including AstraZeneca scientists, in partnership with the National Institutes of Health’s National Cancer Institute researchers have studied the effect of Calquence on 19 hospitalised patients with Covid-19 disease and severe hypoxia or inflammation.

AstraZeneca Oncology R&D executive vice president José Baselga, said: “The science supporting investigation of the use of Calquence in patients with severe COVID-19 is strong.

“The encouraging preliminary data in this case series has informed the initiation of global phase II trials, notably the CALAVI programme. We look forward to completing recruitment and obtaining data in these trials as soon as possible to further our understanding of what this potential treatment could mean for patients.”

According to the company, virus-induced hyperimmune response or cytokine storm is believed to be a major pathogenic mechanism of respiratory illness in severely ill patients.

The evidence suggests that the dysregulated BTK-dependent lung macrophage signalling would mediate the cytokine storm and plays a crucial role in Covid-19 pneumonia.

CALAVI programme is designed to evaluate the efficacy and safety of Calquence

Calquence is an advanced selective BTK inhibitor currently approved in the US for the treatment of certain haematological malignancies, and is not currently approved in any country to treat patients suffering from illnesses associated with SARS-CoV-2 infection.

The company has announced CALAVI programme, comprising 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.

The clinical trials are aimed at evaluating the addition of Calquence to current BSC in patients who are hospitalised but not on assisted ventilation. The primary efficacy endpoint includes measuring the number of patients alive and free of respiratory failure following treatment.

Calquence is also approved in the US and a few other countries to treat mantle cell lymphoma (MCL) in patients who received at least one prior therapy.