AstraZeneca to stop Calquence Phase III trial early on good results

AstraZeneca (LSE: AZN) today announced positive results from the Phase III ASCEND trial of Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukemia (CLL). Because of the good results, the trial will now be stopped early, the company stated

Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Calquence monotherapy compared to a combination regimen of rituximab plus physician’s choice of idelalisib or bendamustine. Importantly, the safety and tolerability of Calquence was consistent with the known profile.

José Baselga, executive vice president, R&D Oncology of the Anglo-Swedish pharma major, said: “Calquence is the first BTK inhibitor to show benefit in a Phase III trial as a monotherapy compared to current standard-of-care combinations used in relapsed or refractory chronic lymphocytic leukemia. We look forward to presenting detailed results at a forthcoming medical meeting.”