|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
Among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), fixed-duration, first-line treatment with ibrutinib and venetoclax appears to induce both deep and durable responses, according to research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
Previous results from the phase 2 CAPTIVATE study (ClinicalTrials.gov Identifier: NCT02910583), a multicohort study evaluating the safety and efficacy of ibrutinib and venetoclax in CLL/SLL, suggested that the combination is effective in a minimal residual disease cohort. In this presentation, researchers provided results from the fixed-dose cohort.
Overall, 159 patients were enrolled. The median patient age was 60 years, 17% of patients had 17p deletion/TP53 mutation, 18% of patients had an 11q deletion, 19% of patients had a complex karyotype, and 18% of patients had unmutated IGHV. The median time on the study was 27.9 months (range, 0.8-33.2); 92% of patients completed ibrutinib treatment and 94% of patients completed venetoclax treatment.
The overall response rate was 96% (153 patients). The complete remission/complete remission with incomplete hematologic recovery rate was 55% (88 patients), which was a consistent rate among high-risk subgroups. Of these complete responses, 89% were considered durable.
The undetectable minimal residual disease rates in peripheral blood and bone marrow were 77% and 60%, respectively. The 24-month progression-free and overall survival rates were 95% and 98%, respectively.
The most common grade 3 to 4 adverse events were neutropenia (33%), hypertension (6%), and neutrophil count decrease (5%).
Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Ghia P, Allan JN, Siddiqi T, et al. Fixed-duration (FD) first-line treatment (tx) with ibrutinib (I) plus venetoclax (V) for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): primary analysis of the FD cohort of the phase 2 captivate study. J Clin Oncol. 2021;39:(suppl 15; abstr 7501). doi:10.1200/JCO.2021.39.15_suppl.7501