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

pharmafile | May 8, 2019 | News story | Research and Development AstraZeneca, Calquence, pharma 

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).

It was found that use of Calquence as a monotherapy led to statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared to the regimens administered in the second group.

As a result, AZ revealed that the Phase 3 study would end early, now that the drug has proven its efficacy in meeting the trial’s primary endpoint.  

“Calquence is the first BTK inhibitor to show benefit in a Phase 3 trial as a monotherapy compared to current standard-of-care combinations used in relapsed or refractory chronic lymphocytic leukaemia,” commented José Baselga, Executive Vice President, R&D Oncology at AZ. “We look forward to presenting detailed results at a forthcoming medical meeting.”

Matt Fellows

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