08 Dec CMO Jon Cartu Wrote – CAPTIVATE Study: Ibrutinib Plus Venetoclax for First-line Treatme…
07 Dec CAPTIVATE Study: Ibrutinib Plus Venetoclax for First-line Treatment of CLL/SLL
MedicalResearch.com Interview with:
Constantine Tam, M.D.
Hematologist and Disease Group Lead
Low Grade Lymphoma and CLL at
Peter MacCallum Cancer Centre
Victoria, Australia, and
Lead study investigator of CAPTIVATE
MedicalResearch.com: What is the background for this study?
Response: The Phase 2 CAPTIVATE (PCYC-1142) clinical trial evaluated 164 patients younger than 70 years (median age of 58 years) with previously untreated CLL/SLL. Patients were planned to receive ibrutinib for 3 cycles, followed by 12 cycles of ibrutinib and venetoclax in combination. Ninety percent of patients was able to complete the planned therapy. MRD status was evaluated in PB after 6, 9, and 12 cycles and in BM after 12 cycles of the combination.
MedicalResearch.com: What are the main findings?
Response: Results showed uMRD – defined as less than 1 CLL cell per 10,000 leukocytes (MRD<0.01 percent) by flow cytometry of PB or BM samples – was achieved at any time after baseline in PB for 75 percent of patients (122 of 163 patients) and in BM for 72 percent (111 of 155 patients). The proportion of patients who had uMRD in PB increased over time from 57 percent after 6 cycles, 68 percent after 9 cycles, and 73 percent after 12 cycles of ibrutinib plus venetoclax. The high rates of uMRD in BM were consistent across high-risk subgroups, including in patients with del(17p), del(17p) or TP53 mutation, del(11q), complex karyotype, and unmutated IGHV status. In patients with uMRD in PB with matched BM samples, 93 percent of patients had uMRD in both PB and BM. With media follow-up of 14.7 months, 3 patients (2 percent) experienced disease progression.
MedicalResearch.com: What should readers take away from your report?
Response: The oral regimen of ibrutinib alone, followed by combined ibrutinib and venetoclax, delivered a promising rate of disease clearance – an important indicator of deep response – in previously untreated patients with CLL, with 75 percent and 72 percent of patients having undetectable disease (MRD) in the blood and bone marrow, respectively. I’m really encouraged by these data as it shows that an all-oral, chemotherapy free regimen has the potential to achieve deep remissions that may permit treatment cessation. In addition, the regimen was well tolerated, with low rates of discontinuation and low rates of tumor lysis syndrome.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We need further follow-up to determine the durability of responses in MRD-negative patients, in order to guide the development of limited duration regimens. In addition, this cohort of patients have been randomized (depending on their MRD status) to different maintenance strategies. This additional data will hopefully read out in the near future and guide optimal management of patients following ibrutinib + venetoclax induction.
Any disclosures? I receive honoraria and research funding from Janssen, Pharmacyclics and Abbvie.
Citation: ASH December 2019
Abstract #35: Ibrutinib Plus Venetoclax for First-line Treatment of CLL/SLL: Results from the MRD Cohort of Phase 2 CAPTIVATE Study (PCYC-1142)
Constantine Tam, M.D., Hematologist and Disease Group Lead, Low Grade Lymphoma and CLL at Peter MacCallum Cancer Centre, Victoria, Australia, and lead study investigator of CAPTIVATE
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