Results of Phase III SEQUOIA Trial of Zanubrutinib in CLL
Posted: Tuesday, January 21, 2020
Patients with chronic lymphocytic leukemia (CLL) who have a deletion in chromosome 17p13.1 [del(17p)] and have never been treated before seem to be able to both tolerate and benefit from therapy with the next-generation Bruton’s tyrosine kinase inhibitor zanubrutinib. Constantine S. Tam, MBBS, MD, of St. Vincent’s Hospital in Australia, presented work on behalf of her colleagues at the 2019 American Society for Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida (Abstract 499).
The phase III trial included a nonrandomized cohort of 109 treatment-naive patients with CLL or small lymphocytic leukemia and del(17p). Patients were treated with 160 mg of zanubrutinib twice a day. At the time of data cutoff, all patients had received at least one dose of the medication.
A total of 106 patients remained on the therapy at the time of data cutoff. Of them, 90 patients could be evaluated for efficacy, at a median follow-up of 7 months. The overall response rate was 92.2%, with 75.6% of patients achieving a partial response. Two patients had disease progression, which was reported to be due to Richter’s transformation. None of these patients experienced disease progression.
Common adverse events (experienced by at least 10% of patients) included contusion (20.2%), rash (11.0%), upper respiratory infection (10.1%), and nausea (10.1%). A total of 33 patients (30.3%) reported grade 3 or higher adverse events, with the most common being neutropenia or decreased neutrophil count (10 patients), anemia, pneumonia, nephrolithiasis, and hypertension (each 2 patients). One patient died as a result of grade 5 pneumonia, which resulted 8 days after the last dose of zanubrutinib. Other adverse events of note included infection (39.4%), bruising (24.8%), minor bleeding (18.3%), arthralgia/myalgia (8.3%), diarrhea (8.3%), anemia (6.4%), thrombocytopenia (5.5%), fatigue (5.5%), headache (4.6%), petechiae (4.6%), second primary malignancy (2.8%), and major bleeding (2.8%).
Disclosure: For full disclosures of the study authors, visit ash.confex.com.