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Acalabrutinib Improves PFS in Relapsed/Refractory CLL
Results from a phase 3 trial demonstrate significantly improved progression-free survival (PFS) with acalabrutinib compared with idelalisib plus rituximab or bendamustine plus rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (CLL; J Clin Oncol. 2020 May 27. Epub ahead of print).
The ASCEND trial, a global, multicenter, randomized, open-label, phase 3 study randomized patients in a 1:1 ratio to receive single-agent acalabrutinib, a highly selective, potent, Bruton’s tyrosine kinase inhibitor, or investigators’ choice of either idelalisib plus rituximab or bendamustine plus rituximab. Patients were stratified by del(17p) status, Eastern Cooperative Oncology Group (ECOG) performance status score, and number of prior lines of therapy.
The primary end point of the trial was PFS assessed by an independent review committee in the intent-to-treat population. Secondary end points included overall response rate (ORR), overall survival (OS), and safety.
A total of 398 patients were assessed between February 21, 2017 and January 17, 2018 and 310 patients were randomized to acalabrutinib (n = 155) or investigators’ choice: idelalisib-rituximab (n = 119) or bendamustine-rituximab (n = 36).
After a median follow-up 16.1 months, median PFS had not been reached with acalabrutinib compared with 16.5 months with investigators’ choice of therapy (P <.0001). The estimated 12-month PFS was 88% and 68%, respectively.
Serious adverse events were reported in 44 (29%) of 154 patients receiving acalabrutinib, 66 (56%) of 118 patients receiving idelalisib-rituximab, and 9 (26%) of 35 patients receiving bendamustine-rituximab. Deaths were reported for 15 (10%) of 154 patients, 13 (11%) of 118 patients, and 9 (14%) of 35 patients who received acalabrutinib, idelalisib-rituximab, and bendamustine-rituximab, respectively.
Acalabrutinib demonstrated an acceptable safety profile and significantly improved PFS over idelalisib-rituximab or bendamustine-rituximab in patients with relapsed/refractory CLL in this phase 3 trial.—Janelle Bradley
