▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced the latest results of the CAPTIVATE Phase 2 clinical study, which evaluated a fixed-duration (FD) regimen of Imbruvica (ibrutinib) in combination with venetoclax.（I+V）Efficacy in previously untreated patients with chronic lymphocytic leukemia (CLL).Analysis shows that the 5-year overall survival rate of all treated patients is as high as 96%!

The latest results of the CAPTIVATE study show that at a median follow-up of 61.2 months, 67% (95% CI: 59-74) of the 159 patients treated with FDI+V were progression-free and still alive at 5 years. Notably,Even after a follow-up period of up to 5.5 years, the median progression-free survival (PFS) of patients has not been reached., which indicates that the disease continues to be under control.The 5-year overall survival rate for all patients receiving treatment was 96%, while those with high-risk genetic features (i.e., del[17p]/TP53The overall survival rate for patients with mutations or complex karyotypes was 90% (95% CI: 77-96), compared to 100% for patients without these characteristics.Moreover, patients who achieve minimal residual disease negativity (uMRD) in both blood and bone marrow have a better prognosis. The 5-year PFS rate for patients achieving uMRD in bone marrow at 3 months post-treatment (EoT+3) was 84% (95% CI: 73-90), compared to 50% (95% CI: 36-62) for those who did not achieve uMRD at EoT+3.

In a small number of patients who relapsed after FDI+V treatment, subsequent treatment with an ibrutinib-based regimen demonstrated durable remission and acceptable safety, even in patients with high-risk genetic features.Among the 61 patients who experienced disease progression after completing FD I+V treatment, 32 received subsequent treatment, including single-agent ibrutinib (n=25) or FD I+V (n=7).Among patients receiving single-agent ibrutinib, 86% achieved relief during a median treatment period of 21.9 months.Among patients receiving FD I+V treatment, 71% achieved remission during the median treatment period of 13.8 months.

No new safety signals for the FD I+V regimen were observed since the last analysis. Adverse events (AEs) during subsequent treatment were consistent with the known safety profiles of single-agent ibrutinib and I+V.

Imbruvica is an oral, once-daily Bruton's tyrosine kinase (BTK) inhibitor., jointly developed by Johnson & Johnson and Pharmacyclics, a subsidiary of AbbVie. BTK plays an important role in the survival and proliferation of normal and cancerous B cells. Imbruvica has been approved in more than 100 countries and regions worldwide, treating over 300,000 patients globally.

References:

[1] Updated Phase 2 CAPTIVATE study results demonstrate sustained clinical benefit of fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax as first-line treatment for patients with chronic lymphocytic leukaemia, including those with high-risk disease. Retrieved June 14, 2024 from https://www.globenewswire.com/news-release/2024/06/14/2898796/0/en/Updated-Phase-2-CAPTIVATE-study-results-demonstrate-sustained-clinical-benefit-of-fixed-duration-IMBRUVICA-ibrutinib-plus-venetoclax-as-first-line-treatment-for-patients-with-chron.html

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