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

July 3, 2019
Paolo Ghia, MD

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.