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.
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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.
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AstraZeneca will also be filing Calquence combo data from the Elevate-TN trial, which examined it alongside Roche’s Gazvya. The combo beat out a regimen of chlorambucil chemotherapy and Gazyva at staving off disease progression in previously untreated CLL patients, the drugmaker said earlier this month. Calquence also hit its secondary endpoint in that trial, topping a Gazvya-chemo combo as a solo treatment.
The raft of positive results could help the drug make a run at Johnson & Johnson and AbbVie’s oncology blockbuster Imbruvica. But Calquence's nemesis has a major head start thanks to three separate indications in CLL.
In the first quarter, Calquence cleared just $29 million in global sales after a full year on the market, a pittance compared with Imbruvica’s $784 million in the same time span.
Imbruvica also bears an approval in MCL, though AstraZeneca has hopes it can eventually corner that market. The British drugmaker estimated that around 40% of previously untreated MCL patients in the U.S. are on Calquence.
In December, Dave Fredrickson, EVP and global head of AZ’s oncology business unit, said Calquence was pulling 50% of new prescriptions for U.S. patients with relapsed and refractory MCL. Fredrickson said those strong figures boded well for the drug’s chances in MCL over time.