2021 ASCO fixed course of Ibrutinib combined with Venecla regimen achieves considerable efficacy in CLL

The Phase II CAPTIVATE (PCYC-1142) study explored the efficacy and safety of Ibrutinib combined with Venecla (I+V) regimen in the first-line treatment of chronic lymphocytic leukemia (CLL)
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The results of the study announced at the 2020 ASH Conference showed that more than 65% of the patients in the minimal residual disease (MRD) cohort of the study were unable to detect MRD (uMRD) after 12 cycles of I+V treatment.
Follow-up random treatment data showed that The 30-month progression-free survival (PFS) rate of the program exceeds 95%
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The research data results of the fixed course (FD) treatment cohort of the study were announced at the recent 2021 American Society of Clinical Oncology (ASCO) annual meeting
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The editor organizes the main content as follows for the reference of readers
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Research methods: The study included newly-treated CLL/small lymphocytic lymphoma (SLL) patients ≤70 years of age who received 3 cycles of Ibrutinib monotherapy, followed by 12 cycles of I+V regimen treatment (Ibutin Ni: 420 mg orally per day; Venecla: increasing the dose to 400 mg per day)
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The primary endpoint of the study is the complete remission (CR) rate, including complete remission (CRi) with incomplete recovery of blood counts; secondary endpoints include total remission rate (ORR), duration of remission (DOR), uMRD rate (eight-color flow) Cytometry detection <10-4 level), PFS, overall survival (OS), tumor lysis syndrome (TLS) risk reduction, adverse events (AE)
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Results of the study: A total of 159 patients (median age 60 years) were enrolled.
17% of patients had del(17p)/TP53 mutations, 18% of patients had del(11q), 19% of patients had complex karyotypes, 56 % Of patients have no mutation in IGHV
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147 patients (92%) completed the planned treatment with ibrutinib, and 149 patients (94%) completed the planned treatment with Venecla
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At a median follow-up time of 27.
9 months (range: 0.
8-33.
2), the CR rate of patients in the fixed-course treatment cohort was 55% (95%CI: 48%-63%)
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Among 88 patients who got CR, 78 (89%) patients got permanent CR (duration ≥ 1 year)
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One patient died 7 months after obtaining CR, and 9 patients were unable to evaluate the efficacy due to less than one year of follow-up
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The ORR of the patients in the study was 96%, and 77% and 60% of the patients had peripheral blood (PB) uMRD and bone marrow (BM) uMRD, respectively
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The 24-month PFS rate was 95%, and the 24-month OS rate was 98%
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The curative effect of patients with del(17p) is basically similar to that of the overall patients.
The CR rate of patients with del(17p)/TP53 mutation is 56%, and the uMRD rate is 81% (PB) and 41% (BM), 24 months The PFS rate was 84% ​​(95%CI: 63%-94%)
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 Among the 34 patients with a higher risk of TLS at baseline, 32 (94%) patients were reduced to low-medium risk after receiving ibrutinib, and TLS did not occur in the study
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The AEs that occurred in the study were mainly grade 1-2, and the most common grade 3-4 AEs were neutropenia (33%), hypertension (6%), and decrease in the number of neutrophils (5%)
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Ibrutinib was discontinued in 4% of patients due to AEs, and venecola was discontinued in 2% of patients
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Research conclusions The fixed course of I+V chemotherapy without chemotherapy can bring lasting deep relief for newly treated CLL/SLL patients (including patients with high-risk cytogenetic characteristics).
The patients in the study achieved good CR rates and uMRD rates , PFS, OS
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The safety of the I+V regimen was consistent with the known AEs of the two drugs, and no new safety signals appeared
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Reference source: 1.
Paolo Ghia, et al.
Fixed-duration (FD)first-line treatment (tx) with ibrutinib (I) plus venetoclax (V) for chroniclymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysisof the FD cohort of the phase 2 captivate study.
2021 ASCO Annual Meeting.
Abstract7501.
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