^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    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:
    2d
    Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial (clinicaltrials.gov)
    P1/2, N=27, Recruiting, OHSU Knight Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    TP53 (Tumor protein P53) • CD20 (Membrane Spanning 4-Domains A1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CCND1 (Cyclin D1) • KMT2D (Lysine Methyltransferase 2D) • NOTCH2 (Notch 2) • PAX5 (Paired Box 5) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule) • SOX11 (SRY-Box Transcription Factor 11) • NSD2 (Nuclear Receptor Binding SET Domain Protein 2)
    |
    TP53 mutation • Chr del(17p) • Chr t(11;14) • CDKN2A deletion
    |
    Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
    3d
    A prospective, single-arm, multicenter clinical study of zanubrutinib in combination with obinutuzumab and low-dose bendamustine as first-line treatment for high-risk (FLIPI-2 >= 3) follicular lymphoma patients. (ChiCTR2500114118)
    P4, N=25, Not yet recruiting, People‘s Hospital of Xinjiang Uygur Autonomous Region; People‘s Hospital of Xinjiang Uygur Autonomous Region
    New P4 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • bendamustine
    3d
    Zanubrutinib Combined with Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in Treatment-Naive Waldenström's Macroglobulinemia: A Phase II Clinical Study (ChiCTR2500113199)
    P2, N=43, Not yet recruiting, Institute of Hematology, Chinese Academy of Medical Sciences (Chinese Academy of Medical Sciences Hematology Hospital); Institute of Hematology, Chine
    New P2 trial
    |
    Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • bendamustine
    3d
    Immuno and targeted therapy for Richter transformation to diffuse large B-cell lymphoma (ChiCTR2500109894)
    P2, N=34, Not yet recruiting, The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
    New P2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1) • PD-1 (Programmed cell death 1)
    |
    CD20 positive
    |
    lenalidomide • Tevimbra (tislelizumab-jsgr) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Columvi (glofitamab-gxbm)
    6d
    OSU-14266: Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=87, Active, not recruiting, Kerry Rogers | Trial completion date: Dec 2024 --> Apr 2026
    Trial completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • B2M (Beta-2-microglobulin)
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab)
    7d
    OASIS: Obinutuzumab in Adult Rituximab-Dependent Nephrotic Syndrome (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Mario Negri Institute for Pharmacological Research | Trial completion date: Mar 2028 --> Mar 2029 | Trial primary completion date: Mar 2028 --> Mar 2029
    Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab)
    8d
    An Indirect Comparison of Zanubrutinib vs Acalabrutinib Plus Venetoclax in Patients With Treatment-Naive CLL. (PubMed, Blood Adv)
    In the phase 3 randomized SEQUOIA study (NCT03336333), zanubrutinib (arm A) demonstrated superior progression-free survival (PFS) compared with bendamustine-rituximab (BR; arm B) in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) without del(17p). In the phase 3 AMPLIFY study (NCT03836261), acalabrutinib-venetoclax with or without obinutuzumab demonstrated prolonged PFS vs chemoimmunotherapy (investigator's choice of fludarabine, cyclophosphamide, and rituximab [FCR] or BR) in patients with treatment-naive CLL without del(17p) or TP53 mutations...Zanubrutinib also demonstrated longer PFS whether adjusted for age (PFS-INV hazard ratio &lsqb;HR], 0.26; 95% CI, 0.13-0.54; P<.0003) or unadjusted (PFS-INV HR, 0.45; 95% CI, 0.23-0.88; P=.0197). These results highlight zanubrutinib monotherapy as an effective treatment option for all patients with treatment-naive CLL/SLL, including patients who might otherwise be considered for more intensive fixed-duration combination regimens.
    Journal • IO biomarker
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 mutation + Chr del(17p)
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab) • cyclophosphamide • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • bendamustine • fludarabine IV
    10d
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=73, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
    Trial completion date
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    12d
    MAVRiC: Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, AstraZeneca | Trial completion date: Nov 2032 --> May 2029 | Initiation date: Sep 2025 --> Jan 2026 | Trial primary completion date: Nov 2032 --> May 2029
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
    |
    TP53 mutation • IGH mutation
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    12d
    Avo In R/R And Previously Untreated MCL (clinicaltrials.gov)
    P1/2, N=72, Recruiting, Austin I Kim | N=53 --> 72 | Trial completion date: Jun 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Jun 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    12d
    Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma (clinicaltrials.gov)
    P4, N=88, Recruiting, Beijing Tongren Hospital
    New P4 trial
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab) • Inokai (orelabrutinib)
    21d
    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
    |
    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)
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Leukeran (chlorambucil)