The Bruton tyrosine kinase inhibitor showed a statistically-significant and clinically-meaningful improvement in progression-free survival in patients with previously-treated CLL.
Treatment with Calquence (acalabrutinib) monotherapy significantly improved progression-free survival among patients with previously-treated chronic lymphocytic leukemia (CLL), compared with Rituxan (rituximab) in combination with physician’s choice of Zydelig (idelalisib) or Treanda (Bendamustine), according to AstraZeneca, the drug’s manufacturer.
CLL is the most common type of leukemia in adults, accounting for approximately one in four new cases in the US — signaling a need for more treatments.
In the global, randomized, multicenter, open-label phase 3 ASCEND trial, researchers evaluated the efficacy of Calquence in 310 patients with previously-treated CLL. Patients were randomized into two groups: those who received 100 mg of Calquence twice daily until disease progression or those who were given Rituxan plus physician’s choice of Zydelig or Treanda.
Progression-free survival — or the time from treatment to disease worsening or death – assessed by an independent review committee served as the primary endpoint of the study. Secondary study endpoints included physician-assessed progression-free survival, independent review committee- and physician-assessed overall response rate and duration of response, as well as overall survival, patient reported outcomes and time to next treatment.
The ASCEND trial met its primary endpoint, demonstrating a statistically-significant and clinically-meaningful improvement in progression-free survival with Calquence monotherapy compared with Rituxan plus Zydelig or Treanda. In addition, the safety and tolerability of the Bruton tyrosine kinase inhibitor appeared consistent with its known profile.
“Calquence is the first (Bruton tyrosine kinase) 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 leukemia,” José Baselga, executive vice president of R&D Oncology, said in the release, adding that the company plans to present detailed results at a forthcoming medical meeting.