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AstraZeneca to pit blood cancer drug Calquence against COVID-19 with the company's fastest-ever trial launch

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.

AstraZeneca’s trial of leukaemia drug Calquence yields positive results

AstraZeneca confirmed it had recorded positive results from its Phase 3 trial of Calquence plus obinutuzumab in leukaemia.

The trial results showed that 93% of previously untreated chronic lymphocytic leukaemia patients taking Calquence and the cancer drug obinutuzumab, remained free of disease progression or death at 24 months. It also found that 87% of patients just taking Calquence had a similar experience.

FDA approves AstraZeneca’s Calquence in chronic lymphoma

The FDA has approved AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) in the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).

The US approval granted under the FDA’S Real-Time Oncology Review was one of the first to be authorised under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among international partners.  The FDA also collaborated with the Australian Therapeutic Goods Administration and Health Canada on the review of Calquence.

AstraZeneca's Calquence shows strength in most common adult leukaemia

AstraZeneca has unveiled new Phase 3 data for Calquence (acalabrutinib) in treatment-naïve chronic lymphocytic leukaemia, showing that the drug met its primary endpoint when used in combination with obinutuzumab.

The data showed that Calquence use led to a “statistically-significant and clinically-meaningful improvement” in progression-free survival (PFS) compared to chemotherapy-based chlorambucil and obinutuzumab combo treatment, meeting its primary endpoint early

AZ ends Calquence trial early after Phase 3 success in chronic lymphocytic leukaemia

AstraZeneca has unveiled new Phase 3 data on the efficacy of its Bruton tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in the treatment of previously-treated patients with chronic lymphocytic leukaemia (CLL), demonstrating that the therapy “significantly increased the time patients live without disease progression” in interim analysis.

In the study, 310 participants were randomised into two groups, with one group receiving Calquence 100mg twice daily, and the second group receiving rituximab plus either Roche’s Mabthera (idelalisib) or Gilead’s Zydelig (bendamustine).

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