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DRUG:

Gazyva (obinutuzumab)

i
Other names: GA101, R 7159, RO 5072759, GA 101, R7159, RG 7159, RG7159, RO5072759, GA-101, R-7159, RG-7159, RO-5072759
Company:
Biogen, Nippon Shinyaku, Roche
Drug class:
CD20 inhibitor
Related drugs:
7d
The Landscape and Evolution of Clonal Hematopoiesis in Chronic Lymphocytic Leukemia. (PubMed, Blood)
To characterize CH in CLL, 620 patients from two German CLL Study Group trials were analyzed (CLL12 (ibrutinib vs. placebo) and CLL14 (venetoclax-obinutuzumab [Ven-Obi] vs. chlorambucil-obinutuzumab [Clb-Obi])) using error-corrected next-generation sequencing with a VAF threshold of 0.5%. In contrast, CH had no prognostic impact in patients receiving targeted therapies. This study demonstrates the high prevalence of CH, highlights its differential impact across various CLL therapies and underscores its adverse influence on patient outcomes.
Journal
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TP53 (Tumor protein P53) • DNMT3A (DNA methyltransferase 1) • ASXL1 (ASXL Transcriptional Regulator 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • CD34 (CD34 molecule) • BAX (BCL2-associated X protein) • PPM1D (Protein Phosphatase Mg2+/Mn2+ Dependent 1D)
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Leukeran (chlorambucil)
11d
Trial completion date • Trial primary completion date • Adverse events
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Gazyva (obinutuzumab) • surzetoclax (ABBV-453)
11d
New P2 trial
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TP53 (Tumor protein P53)
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TP53 mutation
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Gazyva (obinutuzumab) • Yescarta (axicabtagene ciloleucel) • Carteyva (relmacabtagene autoleucel) • Columvi (glofitamab-gxbm)
11d
First-line treatment for CLL in the era of targeted therapy. (PubMed, Blood Cancer J)
The primary first-line treatment options for CLL comprise continuous therapies based on the BTK inhibitors ibrutinib, zanubrutinib, or acalabrutinib, or fixed-duration regimens combining the BCL2 inhibitor venetoclax with obinutuzumab or the BTK inhibitors ibrutinib or acalabrutinib (with or without obinutuzumab). Selecting the appropriate targeted therapy requires careful evaluation of a multitude of factors, including molecular disease features (especially del[17p]/TP53 and IGHV mutational status), comorbidities, comedications, and the patient's preferences. Focusing on primary treatment options, we review data from the key controlled trials that support the first-line use of targeted therapies for patients with CLL, consider ongoing trials that may support clinical decision-making in the future, and assess the potential to personalize treatment regimens in CLL based on minimal residual disease status.
Review • Journal • IO biomarker
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TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
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TP53 mutation • IGH mutation
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib)
12d
Successful Zanubrutinib Monotherapy in a Rare CNS Presentation of Relapsed CLL. (PubMed, Case Rep Hematol)
We report a case of a 63-year-old male with a history of CLL previously treated with ibrutinib but discontinued early due to intolerance. As a result, the patient was then treated with obinutuzumab plus venetoclax, achieving undetectable minimal residual disease (MRD) but relapsed after 2 years with CNS involvement...He remains in complete remission with continued daily zanubrutinib 6 months follow-up; no significant adverse effects were observed. This case highlights the rare occurrence of CNS involvement in CLL and is the first to demonstrate successful CNS disease eradication with zanubrutinib monotherapy.
Journal
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CD5 (CD5 Molecule)
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)
12d
Trial completion date • Trial primary completion date
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gemcitabine • Rituxan (rituximab) • Gazyva (obinutuzumab) • oxaliplatin • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
13d
Study of Epcoritamab as a Consolidation Therapy in CLL/SLL (clinicaltrials.gov)
P2, N=22, Recruiting, Zulfa Omer | Not yet recruiting --> Recruiting
Enrollment open
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MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • SF3B1 (Splicing Factor 3b Subunit 1) • CD79B (CD79b Molecule) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • BIRC3 (Baculoviral IAP repeat containing 3) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • H1-4 (H1.4 Linker Histone, Cluster Member) • NFKBIE (NFKB Inhibitor Epsilon) • ZMYM3 (Zinc Finger MYM-Type Containing 3) • CHD2 (Chromodomain Helicase DNA Binding Protein 2) • FCER2 (Fc Fragment Of IgE Receptor II)
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Chr del(11q)
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clonoSEQ
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Gazyva (obinutuzumab) • Epkinly (epcoritamab-bysp)
13d
Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study (clinicaltrials.gov)
P2/3, N=20, Recruiting, Radboud University Medical Center | Not yet recruiting --> Recruiting
Enrollment open
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Gazyva (obinutuzumab)
27d
New P2 trial
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lenalidomide • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)
30d
Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma (clinicaltrials.gov)
P2, N=36, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Dec 2025 --> Dec 2027
Trial primary completion date
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Gazyva (obinutuzumab) • golcadomide (CC-99282)
1m
Enrollment open
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lenalidomide • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)
1m
Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial (clinicaltrials.gov)
P2, N=33, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Aug 2028 --> Jun 2029 | Trial primary completion date: Aug 2028 --> Jun 2029
Enrollment open • Trial completion date • Trial primary completion date
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Venclexta (venetoclax) • Gazyva (obinutuzumab) • Epkinly (epcoritamab-bysp)