CLL Coverage from Every Angle
Advertisement
Advertisement

ASH 2021: Early Results With Zanubrutinib Plus Venetoclax in High-Risk CLL

By: Sarah Campen, PharmD
Posted: Wednesday, December 15, 2021

The combination of the Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib and venetoclax appears to be well tolerated in patients with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with deletion of chromosome 17p13 [del(17p)]. These early results are from arm D of the phase III SEQUOIA trial, presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 67). According to Alessandra Tedeschi, MD, of Niguarda Hospital, Milan, Italy, and colleagues, no new safety signals were reported in this high-risk population.

In this open-label, multicenter trial, 35 patients with centrally confirmed del(17p) were enrolled to receive zanubrutinib at 160 mg twice daily for 3 months followed by zanubrutinib at 160 mg plus venetoclax at 400 mg following a ramp-up cycle. Almost all patients (94.3%) had CLL and high-risk characteristics including Binet stage C (51.5%), bulky disease (42.9%), unmutated IGHV locus (85.3%), elevated β2-microglobulin (71.4%), and a median del(17p) frequency of 81.5%.

As for safety, adverse events and serious adverse events were reported in 29 patients (82.9%) and 4 patients (11.4%), respectively. The most common adverse events included diarrhea (n = 5), neutropenia (n = 5), fatigue (n = 4), nausea (n = 4), and petechiae (n = 4). One-third of patients experienced grade 3 or higher adverse events. To date, no tumor-lysis syndrome has been reported.

Among the 31 patients who reached the initial efficacy assessment at 3 months after starting zanubrutinib, the overall response rate was 96.8%. Progressive disease was reported in one patient after having an initial partial response while on combination therapy. Enrollment in the study continues, with a goal of approximately 80 patients.

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



By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.