AstraZeneca’s fixed-duration Calquence combo wins FDA nod as BeOne CLL rivalry heats up
AstraZeneca has secured a key regulatory win in its effort to reclaim the lead in the BTK inhibitor market, with the FDA approving its combination of Calquence plus Venclexta as the first all-oral, fixed-duration regimen for first-line chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
While patients with newly diagnosed CLL typically take a BTK drug like Calquence indefinitely until disease progression, the new approval offers a better quality-of-life alternative by limiting treatment to 14 months.
“The continuous regimens frequently used to treat chronic lymphocytic leukemia often come with side effects that may become burdensome to patients over time,” Jennifer Brown, M.D., Ph.D., from the Dana-Farber Cancer Institute, said in a Feb. 20 statement, adding that the Calquence combo gives doctors greater flexibility to tailor treatment plans.
The approval arrives as BeOne Medicines continues to widen its lead in the BTK inhibitor space with Brukinsa (zanubrutinib). While AZ hopes its time-limited option will sway clinicians, BeOne leadership has historically dismissed any threat from the Calquence regimen, betting instead on its own BTK/BCL-2 candidate.
Brown is the principal investigator of the phase 3 Amplify trial that supported the FDA decision on Calquence.
In the study, patients who received Calquence (acalabrutinib) and AbbVie and Roche’s Venclexta (venetoclax) had a 35% lower chance of disease progression or death compared with those who received the investigator’s choice of a rituximab-based chemotherapy. At the time of the analysis, patients’ median progression-free survival time was not estimable in the fixed-duration combo arm and landed at 47.6 months in the control group.
With a median follow-up of 41 months, 6% of patients in the Calquence-Venclexta group have died, compared with 14% in the comparator arm.
