The Phase II trials evaluating Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet their primary efficacy endpoint. According to
The CALAVI programme comprised two Phase II trials investigating acalabrutinib plus BSC versus BSC alone in patients hospitalised with COVID-19 but not on mechanical ventilation or in the intensive care unit. The primary endpoint measured respiratory failure or death.
The safety and tolerability profiles for Calquence in the CALAVI Phase II trials were consistent with previous trials with no new safety signals reported.
Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton's tyrosine kinase (BTK) being trialled in various haematologic oncology indications. In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion. It was believed that due to the immune component in COVID-19 associated respiratory failure, Calquence may be beneficial to patients.
According to AstraZenca, the results of the CAVALI trials do not impact approved indications or pending approvals for Calquence in patients with blood cancers.
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