Behind the CAPTIVATE Trial: Ibrutinib Plus Venetoclax in CLL/SLL

Paolo Ghia, MD, PhD, deputy director of the Division of Experimental Oncology in San Raffaele Scientific Institute in Milan, Italy, full professor of medical oncology, a group leader in the B-cell Neoplasia Unit, and the head of the Strategic Research Program on CLL at the Università Vita Salute San Raffaele, discusses background of the phase 2 CAPTIVATE trial (NCT02910583).

CAPTIVATE sought to investigate the safety and efficacy of ibrutinib (Imbruvica) in combination with venetoclax (Venclexta) in patients with chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL).

Five-year follow-up data from the CAPTIVATE trial were recently presented by Ghia.

Transcription:

0:09 | The CAPTIVATE study is phase 2, international study that includes 2 different cohorts of patients treated in the frontline. Patients with CLL were treated with 3 months of ibrutinib, followed by 12 months of the combination between ibrutinib and the BCL2 inhibitor venetoclax. The 2 cohorts differentiate because there is an MRD cohort, minimal residual disease, that is driven by the assessment of minimal residual disease at the end of the treatment. Those who have achieved undetectable MRD have been randomized to either placebo, so to stop the treatment or to continuous treatment with ibrutinib.

0:52 | There is a second cohort which is a fixed-duration cohort where every patient at the end of the 15 months of the treatment stops the treatment with ibrutinib and venetoclax. We pulled together all the patients who stopped the treatment, either because they reached undetected MRD in the first cohort, or because by design, they had to stop it in the second cohort, and we analyzed if and how we could retrieve these patients in case of progression.

1:22 | Out of 202 patients, 53 patients progressed in 5 years. Some of them, not all of them, needed treatment. And in particular, 18 of them did not yet need treatment, though they progressed, and the rest have been treated with either ibrutinib alone continuous therapy, or they have been retreated, 6 of them with ibrutinib plus venetoclax. Seven patients have been treated with other treatment at the discretion of the physician.