ORCID Profile
0000-0002-0064-4549
Current Organisation
University of California, San Diego
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Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683828.V1
Abstract: Supplementary Table S1. Patient demographics and disease characteristics at baseline by cohort.
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683831.V1
Abstract: Supplementary Figure S1. Kaplan-Meier curves of progression-free survival (A) and overall survival (B) in the total pooled population of patients treated with fixed-duration ibrutinib plus venetoclax in the FD cohort and the MRD cohort placebo arm. Tick marks indicate censored patients.
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307753.V1
Abstract: Representativeness Data
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307762
Abstract: Supplementary Figure S1. Kaplan-Meier curves of progression-free survival (A) and overall survival (B) in the total pooled population of patients treated with fixed-duration ibrutinib plus venetoclax in the FD cohort and the MRD cohort placebo arm. Tick marks indicate censored patients.
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307753
Abstract: Representativeness Data
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307756
Abstract: Supplementary Table S2. Sensitivity analysis of outcomes in patients with versus without high-risk features, excluding patients from the CAPTIVATE MRD cohort placebo arm
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.C.6684414
Abstract: AbstractPurpose: The CAPTIVATE study investigated first-line ibrutinib plus venetoclax for chronic lymphocytic leukemia in 2 cohorts: minimal residual disease (MRD)-guided randomized discontinuation (MRD cohort) and Fixed Duration (FD cohort). We report outcomes of fixed-duration ibrutinib plus venetoclax in patients with high-risk genomic features [del(17p), i TP53 /i mutation, and/or unmutated immunoglobulin heavy chain (IGHV)] in CAPTIVATE. Patients and Methods: Patients received three cycles of ibrutinib 420 mg/day then 12 cycles of ibrutinib plus venetoclax (5-week r -up to 400 mg/day). FD cohort patients ( i n /i = 159) received no further treatment. Forty-three MRD cohort patients with confirmed undetectable MRD (uMRD) after 12 cycles of ibrutinib plus venetoclax received randomized placebo treatment. Results: Of 195 patients with known status of genomic risk features at baseline, 129 (66%) had ≥1 high-risk feature. Overall response rates were % regardless of high-risk features. In patients with and without high-risk features, respectively, complete response (CR) rates were 61% and 53% best uMRD rates: 88% and 70% (peripheral blood) and 72% and 61% (bone marrow) 36-month progression-free survival (PFS) rates: 88% and 92%. In subsets with del(17p)/ i TP53 /i mutation ( i n /i = 29) and unmutated IGHV without del(17p)/ i TP53 /i mutation ( i n /i = 100), respectively, CR rates were 52% and 64% uMRD rates: 83% and 90% (peripheral blood) and 45% and 80% (bone marrow) 36-month PFS rates: 81% and 90%. Thirty-six–month overall survival (OS) rates were % regardless of high-risk features. Conclusions: Deep, durable responses and sustained PFS seen with fixed-duration ibrutinib plus venetoclax are maintained in patients with high-risk genomic features, with similar PFS and OS to those without high-risk features. i a href="lincancerres/article/doi/10.1158/1078-0432.CCR-23-0807" target="_blank" See related commentary by Rogers, p. 2561 /a /i /
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307759
Abstract: Supplementary Table S1. Patient demographics and disease characteristics at baseline by cohort.
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.C.6684414.V1
Abstract: AbstractPurpose: The CAPTIVATE study investigated first-line ibrutinib plus venetoclax for chronic lymphocytic leukemia in 2 cohorts: minimal residual disease (MRD)-guided randomized discontinuation (MRD cohort) and Fixed Duration (FD cohort). We report outcomes of fixed-duration ibrutinib plus venetoclax in patients with high-risk genomic features [del(17p), i TP53 /i mutation, and/or unmutated immunoglobulin heavy chain (IGHV)] in CAPTIVATE. Patients and Methods: Patients received three cycles of ibrutinib 420 mg/day then 12 cycles of ibrutinib plus venetoclax (5-week r -up to 400 mg/day). FD cohort patients ( i n /i = 159) received no further treatment. Forty-three MRD cohort patients with confirmed undetectable MRD (uMRD) after 12 cycles of ibrutinib plus venetoclax received randomized placebo treatment. Results: Of 195 patients with known status of genomic risk features at baseline, 129 (66%) had ≥1 high-risk feature. Overall response rates were % regardless of high-risk features. In patients with and without high-risk features, respectively, complete response (CR) rates were 61% and 53% best uMRD rates: 88% and 70% (peripheral blood) and 72% and 61% (bone marrow) 36-month progression-free survival (PFS) rates: 88% and 92%. In subsets with del(17p)/ i TP53 /i mutation ( i n /i = 29) and unmutated IGHV without del(17p)/ i TP53 /i mutation ( i n /i = 100), respectively, CR rates were 52% and 64% uMRD rates: 83% and 90% (peripheral blood) and 45% and 80% (bone marrow) 36-month PFS rates: 81% and 90%. Thirty-six–month overall survival (OS) rates were % regardless of high-risk features. Conclusions: Deep, durable responses and sustained PFS seen with fixed-duration ibrutinib plus venetoclax are maintained in patients with high-risk genomic features, with similar PFS and OS to those without high-risk features. /
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.C.6684414.V2
Abstract: AbstractPurpose: The CAPTIVATE study investigated first-line ibrutinib plus venetoclax for chronic lymphocytic leukemia in 2 cohorts: minimal residual disease (MRD)-guided randomized discontinuation (MRD cohort) and Fixed Duration (FD cohort). We report outcomes of fixed-duration ibrutinib plus venetoclax in patients with high-risk genomic features [del(17p), i TP53 /i mutation, and/or unmutated immunoglobulin heavy chain (IGHV)] in CAPTIVATE. Patients and Methods: Patients received three cycles of ibrutinib 420 mg/day then 12 cycles of ibrutinib plus venetoclax (5-week r -up to 400 mg/day). FD cohort patients ( i n /i = 159) received no further treatment. Forty-three MRD cohort patients with confirmed undetectable MRD (uMRD) after 12 cycles of ibrutinib plus venetoclax received randomized placebo treatment. Results: Of 195 patients with known status of genomic risk features at baseline, 129 (66%) had ≥1 high-risk feature. Overall response rates were % regardless of high-risk features. In patients with and without high-risk features, respectively, complete response (CR) rates were 61% and 53% best uMRD rates: 88% and 70% (peripheral blood) and 72% and 61% (bone marrow) 36-month progression-free survival (PFS) rates: 88% and 92%. In subsets with del(17p)/ i TP53 /i mutation ( i n /i = 29) and unmutated IGHV without del(17p)/ i TP53 /i mutation ( i n /i = 100), respectively, CR rates were 52% and 64% uMRD rates: 83% and 90% (peripheral blood) and 45% and 80% (bone marrow) 36-month PFS rates: 81% and 90%. Thirty-six–month overall survival (OS) rates were % regardless of high-risk features. Conclusions: Deep, durable responses and sustained PFS seen with fixed-duration ibrutinib plus venetoclax are maintained in patients with high-risk genomic features, with similar PFS and OS to those without high-risk features. i a href="lincancerres/article/doi/10.1158/1078-0432.CCR-23-0807" target="_blank" See related commentary by Rogers, p. 2561 /a /i /
Publisher: American Society of Clinical Oncology (ASCO)
Date: 12-2020
DOI: 10.1200/JCO.20.00948
Abstract: In previous analyses of the MURANO study, fixed-duration venetoclax plus rituximab (VenR) resulted in improved progression-free survival (PFS) compared with bendamustine plus rituximab (BR) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). At the 4-year follow-up, we report long-term outcomes, response to subsequent therapies, and the predictive value of molecular and genetic characteristics. Patients with CLL were randomly assigned to 2 years of venetoclax (VenR for the first six cycles) or six cycles of BR. PFS, overall survival (OS), peripheral-blood minimal residual disease (MRD) status, genomic complexity (GC), and gene mutations were assessed. Of 389 patients, 194 were assigned to VenR and 195 to BR. Four-year PFS and OS rates were higher with VenR than BR, at 57.3% and 4.6% (hazard ratio [HR], 0.19 95% CI, 0.14 to 0.25), and 85.3% and 66.8% (HR, 0.41 95% CI, 0.26 to 0.65), respectively. Undetectable MRD (uMRD) at end of combination therapy (EOCT) was associated with superior PFS compared with low MRD positivity (HR, 0.50) and high MRD positivity (HR, 0.15). Patients in the VenR arm who received ibrutinib as their first therapy after progression (n = 12) had a reported response rate of 100% (10 of 10 evaluable patients) patients subsequently treated with a venetoclax-based regimen (n = 14) had a reported response rate of 55% (six of 11 evaluable patients). With VenR, the uMRD rate at end of treatment (EOT) was lower in patients with GC than in those without GC ( P = .042) higher GC was associated with shorter PFS. Higher MRD positivity rates were seen with BIRC3 and BRAF mutations at EOCT and with TP53, NOTCH1, XPO1, and BRAF mutations at EOT. Efficacy benefits with fixed-duration VenR are sustained and particularly durable in patients who achieve uMRD. Salvage therapy with ibrutinib after VenR achieved high response rates. Genetic mutations and GC affected MRD rates and PFS.
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683828
Abstract: Supplementary Table S1. Patient demographics and disease characteristics at baseline by cohort.
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.CCR-22-2779
Abstract: The CAPTIVATE study investigated first-line ibrutinib plus venetoclax for chronic lymphocytic leukemia in 2 cohorts: minimal residual disease (MRD)-guided randomized discontinuation (MRD cohort) and Fixed Duration (FD cohort). We report outcomes of fixed-duration ibrutinib plus venetoclax in patients with high-risk genomic features [del(17p), TP53 mutation, and/or unmutated immunoglobulin heavy chain (IGHV)] in CAPTIVATE. Patients received three cycles of ibrutinib 420 mg/day then 12 cycles of ibrutinib plus venetoclax (5-week r -up to 400 mg/day). FD cohort patients (n = 159) received no further treatment. Forty-three MRD cohort patients with confirmed undetectable MRD (uMRD) after 12 cycles of ibrutinib plus venetoclax received randomized placebo treatment. Of 195 patients with known status of genomic risk features at baseline, 129 (66%) had ≥1 high-risk feature. Overall response rates were & % regardless of high-risk features. In patients with and without high-risk features, respectively, complete response (CR) rates were 61% and 53% best uMRD rates: 88% and 70% (peripheral blood) and 72% and 61% (bone marrow) 36-month progression-free survival (PFS) rates: 88% and 92%. In subsets with del(17p)/TP53 mutation (n = 29) and unmutated IGHV without del(17p)/TP53 mutation (n = 100), respectively, CR rates were 52% and 64% uMRD rates: 83% and 90% (peripheral blood) and 45% and 80% (bone marrow) 36-month PFS rates: 81% and 90%. Thirty-six–month overall survival (OS) rates were & % regardless of high-risk features. Deep, durable responses and sustained PFS seen with fixed-duration ibrutinib plus venetoclax are maintained in patients with high-risk genomic features, with similar PFS and OS to those without high-risk features. See related commentary by Rogers, p. 2561
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307759.V1
Abstract: Supplementary Table S1. Patient demographics and disease characteristics at baseline by cohort.
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307762.V1
Abstract: Supplementary Figure S1. Kaplan-Meier curves of progression-free survival (A) and overall survival (B) in the total pooled population of patients treated with fixed-duration ibrutinib plus venetoclax in the FD cohort and the MRD cohort placebo arm. Tick marks indicate censored patients.
Publisher: American Chemical Society (ACS)
Date: 31-08-2023
Publisher: American Association for Cancer Research (AACR)
Date: 07-06-2023
DOI: 10.1158/1078-0432.23307756.V1
Abstract: Supplementary Table S2. Sensitivity analysis of outcomes in patients with versus without high-risk features, excluding patients from the CAPTIVATE MRD cohort placebo arm
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683822.V1
Abstract: Representativeness Data
Publisher: American Society of Clinical Oncology (ASCO)
Date: 12-2021
DOI: 10.1200/JCO.21.00807
Abstract: CAPTIVATE ( NCT02910583 ), a randomized phase II study, evaluates minimal residual disease (MRD)-guided treatment discontinuation following completion of first-line ibrutinib plus venetoclax treatment in patients with chronic lymphocytic leukemia (CLL). Previously untreated CLL patients age 70 years received three cycles of ibrutinib and then 12 cycles of combined ibrutinib plus venetoclax. Patients in the MRD cohort who met the stringent random assignment criteria for confirmed undetectable MRD (Confirmed uMRD) were randomly assigned 1:1 to double-blind placebo or ibrutinib patients without Confirmed uMRD (uMRD Not Confirmed) were randomly assigned 1:1 to open-label ibrutinib or ibrutinib plus venetoclax. Primary end point was 1-year disease-free survival (DFS) rate with placebo versus ibrutinib in the Confirmed uMRD population. Secondary end points included response rates, uMRD, and safety. One hundred sixty-four patients initiated three cycles of ibrutinib lead-in. After 12 cycles of ibrutinib plus venetoclax, best uMRD response rates were 75% (peripheral blood) and 68% (bone marrow). Patients with Confirmed uMRD were randomly assigned to receive placebo (n = 43) or ibrutinib (n = 43) patients with uMRD Not Confirmed were randomly assigned to ibrutinib (n = 31) or ibrutinib plus venetoclax (n = 32). Median follow-up was 31.3 months. One-year DFS rate was not significantly different between placebo (95%) and ibrutinib (100% arm difference: 4.7% [95% CI, –1.6 to 10.9] P = .15) in the Confirmed uMRD population. After ibrutinib lead-in tumor debulking, 36 of 40 patients (90%) with high tumor lysis syndrome risk at baseline shifted to medium or low tumor lysis syndrome risk categories. Adverse events were most frequent during the first 6 months of ibrutinib plus venetoclax and generally decreased over time. The 1-year DFS rate of 95% in placebo-randomly assigned patients with Confirmed uMRD suggests the potential for fixed-duration treatment with this all-oral, once-daily, chemotherapy-free regimen in first-line CLL.
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683825
Abstract: Supplementary Table S2. Sensitivity analysis of outcomes in patients with versus without high-risk features, excluding patients from the CAPTIVATE MRD cohort placebo arm
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683825.V1
Abstract: Supplementary Table S2. Sensitivity analysis of outcomes in patients with versus without high-risk features, excluding patients from the CAPTIVATE MRD cohort placebo arm
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683831
Abstract: Supplementary Figure S1. Kaplan-Meier curves of progression-free survival (A) and overall survival (B) in the total pooled population of patients treated with fixed-duration ibrutinib plus venetoclax in the FD cohort and the MRD cohort placebo arm. Tick marks indicate censored patients.
Publisher: American Society of Hematology
Date: 14-09-2023
DOI: 10.1182/BLOODADVANCES.2023010236
Abstract: We evaluated immune cell subsets in patients with chronic lymphocytic leukemia (CLL) who received first-line therapy with 3 cycles of ibrutinib then 13 cycles of ibrutinib plus venetoclax in the minimal residual disease (MRD) cohort of the CAPTIVATE study (NCT02910583). Patients with confirmed undetectable MRD (uMRD) were randomized to placebo or ibrutinib patients without confirmed uMRD were randomized to ibrutinib or ibrutinib plus venetoclax. We compared immune cell subsets in cryopreserved peripheral blood mononuclear cells collected at 7 timepoints with age-matched healthy donors median changes from baseline are reported. CLL cells decreased within 3 cycles after venetoclax initiation and from Cycle 16 onwards were similar to healthy donors (& /=0.8 cells/µL) in Confirmed uMRD patients, and slightly above healthy donor levels in patients without Confirmed uMRD. By 4 months after Cycle 16, normal B cells recovered to healthy donor levels in patients randomized to placebo. Regardless of randomized treatment, abnormal counts of T cells, classical monocytes, and conventional dendritic cells recovered to healthy donor levels within 6 months (‒49%, +101%, and +91% from baseline, respectively) plasmacytoid dendritic cells recovered by cycle 20 (+598%). Infections generally decreased over time regardless of randomized treatment and were numerically lowest in patients randomized to placebo within 12 months after Cycle 16. Sustained elimination of CLL cells and recovery of normal B cells was confirmed in s les from patients treated with fixed-duration ibrutinib plus venetoclax in the GLOW study (NCT03462719). These results demonstrate promising evidence of restoration of normal blood immune composition with ibrutinib plus venetoclax.
Publisher: American Association for Cancer Research (AACR)
Date: 14-07-2023
DOI: 10.1158/1078-0432.23683822
Abstract: Representativeness Data
Location: United States of America
No related grants have been discovered for Thomas Kipps.