AstraZeneca's Calquence sets Imbruvica in its sights with big CLL survival numbers

When AstraZeneca ended a late-stage trial for Calquence early after seeing promising results, the news boded well for the drug’s chances in previously treated chronic lymphocytic leukemia (CLL). Now, the drugmaker has unveiled the detailed data it plans to take before regulators later this year. At an average of 16.1 months, Calquence reduced the risk of CLL progression or death by 69% compared with standard-of-care regimens of Roche's Rituxan combined with chemo drug bendamustine or Gilead's Zydelig. At 12 months, it had stopped CLL progression in 88% of patients, compared with just 68% of those in the control arm, according to data from a phase 3 trial dubbed Ascend. “These data add to the growing body of evidence to support the profile of Calquence as a selective BTK inhibitor that offers a chemotherapy-free treatment option with a favorable safety profile in chronic lymphocytic leukemia, a life-threatening disease,” José Baselga, AstraZeneca’s VP of oncology R&D, said in a statement. Baselga said AstraZeneca would take data from the Ascend trial before regulators later this year. If the company can eventually snag a green light in CLL, it'll mean a big boost to Calquence's potential patient population. CLL is the most common form of leukemia, with an estimated 191,000 new cases globally and 20,720 new cases in the U.S. each year, AstraZeneca said. Calquence was first approved to treat mantle cell lymphoma (MCL) in previously untreated patients in October 2017.