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ASCO 2022: 3-Year Follow-up on Fixed-Duration Ibrutinib/Venetoclax in First-Line Setting in CLL

By: Vanessa A. Carter, BS
Posted: Monday, June 6, 2022

William G. Wierda, MD, PhD, of The Ohio State University, Columbus, and colleagues performed the phase II CAPTIVATE study to evaluate first-line ibrutinib plus venetoclax in the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. During the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7519), the study authors presented updated data from a 3-year follow-up that identified no new safety signals in the fixed-duration cohort.

“Fixed-duration ibrutinib plus venetoclax continues to provide deep, durable responses and clinically meaningful progression-free survival, including in patients with high-risk disease features, representing an all-oral, once-daily, chemotherapy-free regimen for previously untreated patients,” mentioned the investigators. “To date, successful single-agent ibrutinib retreatment responses are observed.”

This trial enrolled a total of 159 patients, aged 70 and older, with previously untreated CLL. Participants received 3 cycles of ibrutinib followed by 12 cycles of ibrutinib plus venetoclax. Flow cytometry was used to calculate undetectable measurable residual disease (MRD), and ibrutinib-related serious adverse events reported more than 30 days after the last doses were collected.

Unmutated IGHV was detected in 56% of patients, a complex karyotype was identified in 19%, and 17% had high-risk features of a 17p deletion or TP53 mutation. Almost all participants completed treatment with ibrutinib (92%) and venetoclax (94%), and the median time on study was 39 months. Consistent with patients harboring high-risk features, the objective response rate was 96%. Of note, the rate of complete response rose from 55% to 57%, and 93% of these individuals had responses lasting at least 12 months after study treatment.

Finally, 78% of evaluable patients maintained their undetectable MRD status through 12 months after treatment. Overall survival and progression-free survival rates at 36 months were 98% and 88%, respectively, with similar rates seen in patients with high-risk features. A total of 12 patients were retreated in January 2022 with single-agent ibrutinib. Seven experienced a partial response, and two had stable disease.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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