Examining BTK Inhibition As A Superior Treatment for Relapsed/Refractory CLL

Addressing the need for treatments that are more effective and less toxic for patients with relapsed or refractory chronic lymphocytic leukemia, Paolo Ghia, MD, of the Universita Vita-Salute San Raffaele, and other researchers conducted a phase III randomized, multicentric ASCEND study, testing acalabrutinib monotherapy in comparison with physician’s choice of standard regimens in patients R/R CLL.

Addressing the need for treatments that are more effective and less toxic for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL), Paolo Ghia, MD, of the Universita Vita-Salute San Raffaele, and other researchers conducted a phase III randomized, multicentric study (ASCEND) testing acalabrutinib (Calquence) monotherapy in comparison with physician’s choice of standard regimens in patients R/R CLL.

In theASCEND trial,310 patients were randomized to receive either acalabrutinib (n=155) or rituximab (Rituxan) with idelalisib (Zydelig; n = 119) or bendamustine (n = 36). Efficacy and safety were the main objectives of the study, with progression-free survival by independent review committee being the primary endpoint.

Ghia notes that this study was the first time that a single-agent BTK inhibitor was tested against immunochemotherapy or a novel therapy in a head-to-head trial in CLL.

The study found that progression-free survival was significantly improved with acalabrutinib monotherapy and the treatment was safer compared with both rituximab plus idelalisib and bendamustine plus rituximab in patients with R/R CLL (HR, 0.31; 95% CI, 0.20-0.49;P<.0001), according to data presented at the 2019 EHA Congress.