EHA24 Congress: ASCEND Trial of Acalabrutinib Monotherapy in Resistant CLL
Posted: Thursday, August 1, 2019
For patients with relapsed or refractory chronic lymphocytic leukemia (CLL), acalabrutinib monotherapy may significantly improve progression-free survival, with a more tolerable safety profile than rituximab plus idelalisib or bendamustine, according to results presented at the 24th Annual European Hematology Association (EHA) Congress in Amsterdam (Abstract LB2606). The findings from the ASCEND phase III study were presented by Paolo Ghia, MD, PhD, of Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital, Milan, Italy, and colleagues.
In the randomized, global, multicenter, open-label trial, 310 patients were enrolled to receive acalabrutinib (155 patients), rituximab plus idelalisib (119 patients), or bendamustine plus rituximab (36 patients). Of the study patients, 42% had Rai stage III/IV CLL.
After a median follow-up of 16.1 months, patients treated with acalabrutinib had significantly prolonged progression-free survival (by assessment of an independent review-committee) compared with rituximab plus idelalisib and bendamustine (median not reached vs. 16.5 months, respectively)—representing a 69% reduction in the risk of disease progression or death. At 12 months, progression-free survival rates with acalabrutinib were 88%, and 68% with rituximab plus idelalisib and rituximab. The authors observed progression-free survival improvement with acalabrutinib across subgroups, including del(17p), TP53 mutation, and Rai stage.
The overall response rate did not significantly differ with acalabrutinib versus rituximab plus idelalisib and bendamustine (81% vs. 75%, respectively), and the 12-month overall survival rates for patients treated with acalabrutinib compared with rituximab plus idelalisib and bendamustine were 94% and 91% (with 15 and 18 deaths), respectively. Of the patients randomly assigned to receive rituximab plus idelalisib and bendamustine, 23% crossed over to receive subsequent acalabrutinib monotherapy.
Common all-grade adverse events for patients treated with acalabrutinib were headaches, neutropenia, diarrhea, and anemia and cough. For those treated with rituximab plus idelalisib, diarrhea, neutropenia, pyrexia, and cough were the most common adverse events. And the most common adverse events reported in those treated with bendamustine and rituximab were neutropenia, infusion-related reaction and fatigue, nausea, and pyrexia.
Disclosure: The study authors’ disclosure information may be found at ehaweb.org.
