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Phase II CAPTIVATE Study: The 5.5-Year Update

July 12, 2024

Mid-July 2024

Lara C. Pullen, PhD

Lara C. Pullen, PhD, is a freelance medical writer in Chicago, Illinois.

“Of course, no major conference is complete without a CAPTIVATE update,” began conference co-chair Alexey Valeryevich Danilov, MD, PhD, of City of Hope in Duarte, California, when introducing the first speaker in the Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. William G. Wierda, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, then took the stand to present the latest data from patients, who now have as much as 5.5 years of follow-up in the phase II CAPTIVATE study.

In his update on the all-oral fixed duration (FD) cohort, Dr. Wierda reported that, at 5.5 years, ibrutinib plus venetoclax (Ibr+Ven) continues to provide clinically meaningful progression-free survival (PFS) in patients whose disease has high-risk genomic features, as well as in the overall population of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Moreover, Ibr-based retreatment provides a promising response in patients requiring subsequent therapy after the FD regimen of Ibr+Ven.

Ibr+Ven, an all-oral, once-daily, chemotherapy-free treatment, leverages the compounds’ ability to work synergistically through distinct and complementary modes of action to eliminate resting and dividing CLL subpopulations. The CAPTIVATE study is examining the efficacy and safety of this treatment approach in a multicenter, international trial of Ibr+Ven for previously untreated patients with CLL. The trial includes two cohorts: patients in the FD cohort received three cycles of Ibr and then 12 cycles of Ibr+Ven, and patients in the measurable residual disease (MRD) cohort received three cycles of Ibr and then 12 cycles of Ibr+Ven. Then, patients with confirmed undetectable MRD were randomly assigned one-to-one to receive either Ibr or placebo. Patients in either cohort who experienced progressive disease after completion of FD Ibr+Ven could reinitiate single-agent Ibr. Patients with progressive disease more than 2 years after treatment completion could reinitiate FD Ibr+Ven.

Dr. Weirda presented outcomes after FD treatment with Ibr+Ven in 159 patients. He explained that at 5.5 years of overall follow-up, the cohort had still not reached a point where it was possible to calculate median PFS. Instead, he reported that the overall survival rate was equal to or greater than 90%, regardless of genomic risk features.

In total, 202 patients completed FD Ibr+Ven (159 in FD cohort and 43 in MRD cohort placebo arm). A portion of those patients (n=32) went on to receive Ibr-based retreatment. At a median time on Ibr+Ven retreatment of 13.8 months (range = 3.7-15.1), the objective response rate (ORR) was 71% in seven evaluable patients (best response = one complete response, four partial response, one partial response with lymphocytosis, and one stable disease). There were no new safety signals in the patients who received retreatment.

Dr. Weirda concluded his presentation, stating that at 5.5 years of follow-up, the data indicate Ibr+Ven is an effective FD firstline treatment for CLL/SLL. Moreover, “ibrutinib-based retreatment was an effective treatment for patients who progressed and required retreatment after the ibrutinib and venetoclax,” he said.

Any conflicts of interest declared by the authors can be found in the original abstract.

Reference

Wierda WG, Jacobs R, Barr PM, et al. Outcomes in high-risk subgroups after fixed-duration ibrutinib + venetoclax for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): up to 5.5 years of follow-up in the phase 2 CAPTIVATE study. Abstract 7009. Presented at the 2024 American Society of Clinical Oncology Annual Meeting; June 2, 2024; Chicago, Illinois.

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