^
    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:
    23h
    Have Fixed-Duration (FD) Regimens Delivered on Their Promise in Chronic Lymphocytic Leukemia and What Is the Future of FD Regimens? A Narrative Review. (PubMed, Adv Ther)
    Successful fixed-duration regimens in CLL should achieve deep remission (i.e., undetectable minimal residual disease), sustain long-term progression-free survival, decrease the burden of treatment-related adverse events, and allow for re-treatment with minimal risk of drug resistance. Although fixed-duration treatment represents a positive step forward for most patients with CLL/SLL, the currently approved regimens often fall short in patients at high risk of progression. Continued research and development of next-generation drugs is essential to enhance efficacy and safety, ultimately improving outcomes in all patients with CLL/SLL.
    Review • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    IGH mutation
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    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)
    7d
    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)
    8d
    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
    11d
    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)
    13d
    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)
    13d
    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)
    13d
    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)