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Attend this session at the
2019 ASCO Annual Meeting!


Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Type: Oral Abstract Session

Time: Tuesday June 4, 9:45 AM to 12:45 PM

Location: E451

Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities.

Sub-category:
Chronic Lymphocytic Leukemia (CLL)

Category:
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Meeting:
2019 ASCO Annual Meeting

Abstract No:
7502

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 7502)

Author(s): Kirsten Fischer, Othman Al-Sawaf, Jasmin Bahlo, Anna-Maria Fink, Maneesh Tandon, Mark Dixon, Sandra Robrecht, Kathryn Humphrey, Sebastian Böttcher, Eugen Tausch, Rod Humerickhouse, Barbara Eichhorst, Clemens-Martin Wendtner, Anton W. Langerak, Karl-Anton Kreuzer, Valentin Goede, Stephan Stilgenbauer, Mehrdad Mobasher, Matthias Ritgen, Michael J. Hallek, CLL14 Study Investigators; Department I of Internal Medicine and Center of Integrated Oncology Cologne Bonn, University Hospital, Cologne, Germany; Roche Products Limited, Welwyn Garden City, United Kingdom; Department III of Internal Medicine, University Hospital Rostock, Rostock, Germany; Department III of Internal Medicine, Ulm University, Ulm, Germany; AbbVie Inc., North Chicago, IL; Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany; Department of Immunology, Laboratory Medical Immunology, Erasmus MC, Rotterdam, Netherlands; Oncogeriatric Unit, Dept. of Geriatric Medicine, St. Marien Hospital, Cologne, Germany; Department III of Internal Medicine, Ulm University, Ulm and Department for Hematology, Oncology and Rheumatology, Saarland University Medical School, Homburg/Saar, Germany; Genentech, Inc., South San Francisco, CA; Department II of Internal Medicine, Campus Kiel, University of Schleswig-Holstein, Kiel, Germany; Department I of Internal Medicine and Center of Integrated Oncology Cologne Bonn, University Hospital, Cologne, CECAD (Cluster of Excellence on Cellular Stress Responses in Aging-Associated Diseases), University of Cologne, Cologne, Germany

Abstract Disclosures

Abstract:

Background: The multinational, open-label, phase 3 CLL14 trial compared fixed-duration targeted VenG treatment with chlorambucil-obinutuzumab (ClbG) in previously untreated pts with CLL and comorbidities. Here we present endpoint analyses with particular emphasis on MRD− and PFS. Methods: Pts with a CIRS score >6 and/or an estimated creatinine clearance <70 mL/min were randomized 1:1 to receive equal duration treatment with 12 cycles (C) of standard Clb or Ven 400 mg daily in combination with G for first 6 C. Primary endpoint was PFS. MRD− in peripheral blood (PB) or bone marrow (BM) 3 months (mo) after treatment completion was a key secondary endpoint. MRD was analyzed serially from C4 every 3 mo by an allele-specific oligonucleotide polymerase chain reaction assay (ASO-PCR; cut-off, 10-4) and by next generation sequencing (NGS; cut-offs, 10-4, 10-5,10-6). Results: 432 pts were enrolled; 216 in each treatment group (intent-to-treat population). After 29 mo median follow-up, superior PFS was observed with VenG vs ClbG (HR 0.35; 95% CI 0.23–0.53; P<0.0001). MRD− by ASO-PCR was significantly higher with VenG vs ClbG in both PB (76% vs 35% [P<0.0001]) and BM (57% vs 17% [P<0.0001]) 3 mo after treatment completion. Overall, 75% of VenG MRD-negative pts in PB were also MRD-negative in BM vs 49% in the ClbG group. Landmark analysis for this timepoint by PB MRD status showed that MRD− was associated with longer PFS. Higher MRD− rates were achieved early and were more sustainable with VenG: 81% (VenG) vs 27% (ClbG) of pts were MRD-negative 12 mo after treatment completion; HR for MRD conversion 0.19; 95% CI 0.12–0.30 (median time off-treatment: 19 mo). MRD− rates by NGS confirmed these results; 78% (VenG) vs 34% (ClbG) of pts had MRD− at <10-4, 31% vs 4% at <10-6 and 35% vs 15% at ≥10-6–<10-5, respectively. Conclusions: Fixed-duration VenG induced deep (<10-6 in 1/3 of pts), high, and long lasting MRD− rates (with a low rate of conversion to MRD+ status 1 year after treatment) in previously untreated pts with CLL and comorbidities, translating into improved PFS. Clinical trial information: NCT02242942

 
Other Abstracts in this Sub-Category:

 

1. Acalabrutinib with obinutuzumab (Ob) in treatment-naive (TN) and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Three-year follow-up.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7500 First Author: Jennifer Ann Woyach
Category: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia - Chronic Lymphocytic Leukemia (CLL)

 

2. TRANSCEND CLL 004: Minimal residual disease (MRD) negative responses after lisocabtagene maraleucel (Liso-Cel; JCAR017), a CD19-directed CAR T cell product, in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

Meeting: 2019 ASCO Annual Meeting Abstract No: 7501 First Author: Tanya Siddiqi
Category: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia - Chronic Lymphocytic Leukemia (CLL)

 

3. Final analysis from RESONATE: Six-year follow-up in patients (pts) with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) on ibrutinib.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7510 First Author: Paul M. Barr
Category: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia - Chronic Lymphocytic Leukemia (CLL)

 

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