Updated results from the ASCEND Phase III trial showed that Calquence (acalabrutinib) maintained a statistically-significant progression-free survival (PFS) benefit at three years compared to investigator’s choice of rituximab combined with either idelalisib (IdR) or bendamustine (BR) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults, said the drug’s developer, Anglo-Swedish pharma major AstraZeneca (LSE: AZN).
Calquence gained European approval as a CLL treatment in November 2020, and in the USA a year earlier. It generated first-half 2021 sales of $490 million for the company.
These data, presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, demonstrated Calquence reduced the risk of disease progression or death by 71% versus IdR/BR as assessed by investigators at three years (based on a hazard ratio [HR] of 0.29; 95% confidence interval [CI]: 0.21-0.41; p<0.0001). Similar clinical benefits were observed in an exploratory analysis comparing each regimen with Calquence. Safety and tolerability of Calquence were consistent with earlier findings, with no new safety signals identified.
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