MedicalResearch.com Interview with:
Dr. Danelle James, M.D., M.A.S.
Head of Clinical Science
Pharmacyclics, an AbbVie Company
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: CAPTIVATE is a Phase 2 study investigating IMBRUVICA (ibrutinib) plus VENCLEXTA (venetoclax) for the treatment of Chronic Lymphocytic Leukemia (CLL) in the first-line setting. It was designed to evaluate if remission with undetectable minimal residual disease (MRD) can provide treatment-naïve CLL/SLL patients with treatment holidays (a period of time when a patient is able to stop therapy). The study enrolled 164 patients with previously untreated CLL or SLL.
In preclinical and ongoing clinical studies, we’ve seen complementary activities with this combination. The combination has also previously shown potential for deeper remissions, as well as potential for lower risk of tumor lysis syndrome with ibrutinib as the lead-in therapy.
Early data from CAPTIVATE show promising activity for the combination in this patient population, with 77 percent of the first 30 patients achieving responses with no detectable MRD in the blood after only six cycles of the combination therapy. Approximately nine out of 10 of the first patients achieved undetectable MRD after 12 cycles of combination therapy (which were preceded by three cycles of single agent ibrutinib, for a total of 15 cycles of therapy). Specifically, 86 percent of the first 14 patients achieved undetectable MRD in the marrow and 93 percent in the peripheral blood.
MedicalResearch.com: What should readers take away from your report?
Response: Data from CAPTIVATE highlight the potential to deliver deeper responses and a promising rate of MRD in CLL combining IMBRUVICA and VENCLEXTA. Combination therapy, as conducted in this trial, could dramatically alter the way we treat CLL and other B-cell malignancies without the need for chemotherapy, building on the progress we have seen with IMBRUVICA as a single agent and its ability to providing practitioners and their patients additional options for first-line therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: While the CAPTIVATE trial data we have at ASCO this year is early, the high number of deep responses patients were able to achieve with the all-oral combination therapy of IMBRUVICA and VENCLEXTA builds upon earlier data from external investigators and supports further investigation for patients with CLL or SLL. We are excited to continue deepening our knowledge on this combination therapy, which will be confirmed against CIT in the ongoing phase 3 study GLOW (https://www.clinicaltrials.gov/ct2/show/NCT03462719?term=CLL3011&rank=1). The results we have seen from CAPTIVATE so far also provide further evidence of IMBRUVICA’s ability to work well with other agents, including novel therapies like VENCLEXTA.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: These results, along with previous data studies, including the recently reported progression-free survival (PFS) superiority of ibrutinib plus obinutuzumab over chlorambucil plus obinutuzumab in the phase 3 iLLUMINATE study, build on the chemotherapy-free regimen data available for first-line CLL – ultimately bringing us closer to additional treatment options without the use of chemotherapy for patients with CLL.
Citation: ASCO 2018 Abstract:
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