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ASH 2021: Update From ASCEND Trial of Acalabrutinib Monotherapy for Resistant CLL

By: Joseph Fanelli
Posted: Thursday, December 23, 2021

According to a 3-year follow-up of findings from the phase III ASCEND study, presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 393), the efficacy of acalabrutinib monotherapy was maintained, with a significant progression-free survival benefit for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) when compared with standard-of-care regimens. The next-generation Bruton’s tyrosine kinase inhibitor also maintained an “acceptable tolerability profile” as well, with no new safety findings, reported Paolo Ghia, MD, PhD, of the Università Vita-Salute San Raffaele, Milan, Italy, and colleagues.

In this trial, the authors treated 310 patients with relapsed or refractory CLL with 100 mg of acalabrutinib (155 patients) or an investigator’s choice of idelalisib plus rituximab (119 patients) or bendamustine plus rituximab (36 patients). Patients who experienced disease progression on idelalisib plus rituximab or bendamustine plus rituximab were permitted to cross over to acalabrutinib therapy.

At a median follow-up of 36.0 months and 35.2 months for those treated with acalabrutinib and the standard-of-care regimen, respectively, patients who received acalabrutinib had significantly prolonged progression-free survival (median not reached) compared with the other cohorts (16.8 months). The 36-month progression-free survival rate for those who received acalabrutinib was 36%, compared with 21% for patients treated with idelalisib plus rituximab or bendamustine plus rituximab. The progression-free survival advantage of treatment with acalabrutinib was also seen in high-risk subgroups such as those with del(17p) mutation and unmutated IGHV. In addition, serious adverse events were reported in 38% of patients treated with acalabrutinib, 63% of those treated with idelalisib plus rituximab, and 26% of patients receiving bendamustine plus rituximab.

Disclosure: For full disclosures of the study authors, visit ash.com.



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