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DRUG:

Gazyva (obinutuzumab)

i
Other names: RG 7159, RG7159, RO5072759, GA101, R 7159, RO 5072759, GA 101, R7159
Company:
Biogen, Nippon Shinyaku, Roche
Drug class:
CD20 inhibitor
Related drugs:
8d
BruVenG: Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab (clinicaltrials.gov)
P2, N=50, Recruiting, Weill Medical College of Cornell University | Trial completion date: May 2028 --> Dec 2027 | Trial primary completion date: Mar 2027 --> Jan 2025
Trial completion date • Trial primary completion date • Minimal residual disease
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)
9d
Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia (clinicaltrials.gov)
P2, N=60, Recruiting, Inhye Ahn | Not yet recruiting --> Recruiting | Initiation date: Sep 2024 --> Apr 2024
Enrollment open • Trial initiation date
|
Gazyva (obinutuzumab) • Jaypirca (pirtobrutinib)
10d
17P.176: Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas (clinicaltrials.gov)
P2, N=30, Recruiting, Sidney Kimmel Cancer Center at Thomas Jefferson University | Trial primary completion date: Feb 2024 --> Dec 2024
Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1)
|
Imbruvica (ibrutinib) • Gazyva (obinutuzumab)
13d
Acalabrutinib-based regimens in frontline or relapsed/refractory higher-risk CLL: Pooled analysis of 5 clinical trials. (PubMed, Blood Adv)
To better understand the impact of the second-generation BTKi acalabrutinib, we pooled data from 5 prospective clinical studies of acalabrutinib as monotherapy or in combination with obinutuzumab (ACE-CL-001, ACE-CL-003, ELEVATE-TN, ELEVATE-RR, and ASCEND) in patients with higher-risk CLL in treatment-naive (TN) or relapsed/refractory (R/R) cohorts. The safety profile of acalabrutinib-based therapy in this population was consistent with the known safety profile of acalabrutinib in a broad CLL population. Our analysis demonstrates long-term benefit of acalabrutinib-based regimens in patients with higher-risk CLL, regardless of line of therapy.
Retrospective data • Journal • IO biomarker
|
TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
|
TP53 mutation • IGH mutation
|
Gazyva (obinutuzumab) • Calquence (acalabrutinib)
13d
Enrollment open • Combination therapy
|
Rituxan (rituximab) • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • prednisone • Columvi (glofitamab-gxbm)
14d
Trial completion date • Adverse events
|
Venclexta (venetoclax) • Gazyva (obinutuzumab)
14d
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov)
P1, N=4, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=12 --> 4 | Trial completion date: Mar 2034 --> Jun 2029 | Trial primary completion date: Mar 2025 --> Jun 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab) • prednisone
14d
Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=40, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
Enrollment open
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
|
Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
15d
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=95, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
16d
Enrollment closed
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
16d
Acalabrutinib, venetoclax and obinutuzumab in relapsed CLL: Final efficacy and ctDNA analysis of the CLL2-BAAG trial. (PubMed, Blood)
The phase 2 CLL2-BAAG trial tested the measurable residual disease (MRD)-guided triple combination of acalabrutinib, venetoclax and obinutuzumab after an optional bendamustine debulking in 45 patients with relapsed/refractory CLL (one patient was excluded from the analysis due to a violation of exclusion criteria). The addition of ctDNA-based analyses to FCM MRD assessment seems to improve early detection of relapses. ClinicalTrials.gov Identifier: NCT03787264.
Journal • Circulating tumor DNA
|
TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib) • bendamustine
19d
Asciminib Maintains Antibody-Dependent Cellular Cytotoxicity against Leukemic Blasts. (PubMed, Cancers (Basel))
The introduction of rituximab has improved the outcomes in CD20 positive cases. Other monoclonal antibodies, such as tafasitamab (anti-CD19), obinutuzumab (anti-CD20) and epratuzumab (anti-CD22) have been tested in trials (NCT05366218, NCT04920968, NCT00098839)...In contrast to ATP site inhibitors such as dasatinib and ponatinib, the novel first-in-class selective allosteric ABL myristoyl pocket (STAMP) inhibitor asciminib did not significantly impact ADCC in our settings. Our results suggest that asciminib should be considered in clinical trials.
Journal
|
ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
BCR-ABL1 fusion • CD20 positive
|
dasatinib • Rituxan (rituximab) • Iclusig (ponatinib) • Gazyva (obinutuzumab) • Scemblix (asciminib) • Monjuvi (tafasitamab-cxix) • Epratucyn (epratuzumab)
20d
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov)
P1, N=12, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Mar 2024 --> Mar 2025
Trial primary completion date
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab) • prednisone
20d
Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers (clinicaltrials.gov)
P1, N=0, Withdrawn, Weill Medical College of Cornell University | N=30 --> 0 | Initiation date: Jun 2023 --> Nov 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2024 --> Dec 2025
Enrollment change • Trial initiation date • Trial withdrawal • Trial primary completion date • Combination therapy
|
Keytruda (pembrolizumab) • Gazyva (obinutuzumab) • Anyara (naptumomab estafenatox)
22d
New P1/2 trial
|
Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
23d
Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Beth Christian | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
Venclexta (venetoclax) • lenalidomide • Gazyva (obinutuzumab)
24d
Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=40, Not yet recruiting, City of Hope Medical Center | Initiation date: Mar 2024 --> Jun 2024
Trial initiation date
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
|
Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
27d
PORTAL: A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab as a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=99, Not yet recruiting, University College, London | Trial completion date: Jan 2028 --> Jul 2028 | Initiation date: Jan 2024 --> Apr 2024 | Trial primary completion date: Jan 2028 --> Jan 2027
Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
|
CD20 positive
|
Gazyva (obinutuzumab) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
27d
Phase classification • Combination therapy
|
Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm) • maplirpacept (TTI-622)
1m
New P2 trial
|
Gazyva (obinutuzumab) • Jaypirca (pirtobrutinib)
1m
Trial completion date • Adverse events • Combination therapy
|
Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • prednisone • bendamustine • Epkinly (epcoritamab-bysp)
1m
Prognostication in chronic lymphocytic leukemia. (PubMed, Semin Hematol)
On the opposite side of the spectrum, IGHV mutated patients devoid of TP53 disruption benefit the most from fixed-duration therapy with venetoclax-obinutuzumab. In the context of the aggressive transformation of CLL, namely Richter syndrome, the clonal relationship to the CLL counterpart represents the strongest prognostic biomarker. Clonally related Richter syndrome still represents an unmet clinical need which requires further efforts to identify new therapeutic strategies.
Journal • IO biomarker
|
IGH (Immunoglobulin Heavy Locus)
|
TP53 mutation • IGH mutation
|
Venclexta (venetoclax) • Gazyva (obinutuzumab)
1m
NCI-2021-12489: Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P2, N=42, Recruiting, University of Washington | Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025
Trial completion date • Trial primary completion date
|
Gazyva (obinutuzumab) • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
1m
New P2 trial • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2)
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • Itari (linperlisib)
1m
Enrollment open
|
Gazyva (obinutuzumab)
1m
Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=23, Active, not recruiting, Emory University | Trial primary completion date: Sep 2023 --> Sep 2024
Trial primary completion date
|
CCND1 (Cyclin D1)
|
Chr t(11;14)
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • bendamustine
2ms
Trial completion • Combination therapy • Metastases
|
MSI (Microsatellite instability) • CEACAM5 (CEA Cell Adhesion Molecule 5)
|
Tecentriq (atezolizumab) • Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • cibisatamab (RG7802)
2ms
Venetoclax Initiation in Chronic Lymphocytic Leukemia: International Insights and Innovative Approaches for Optimal Patient Care. (PubMed, Cancers (Basel))
In addition to summarizing the evidence for venetoclax's efficacy and safety, this review uses hypothetical patient scenarios based on risk level for TLS (high, medium, low) to share the authors' clinical experience with venetoclax initiation and present global approaches utilized in various treatment settings. These hypothetical scenarios highlight the importance of a multidisciplinary approach and shared decision-making, outlining best practices for venetoclax initiation and overall optimal treatment strategies in patients with CLL.
Review • Journal • IO biomarker
|
TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • IGH (Immunoglobulin Heavy Locus)
|
TP53 mutation • IGH mutation
|
Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab)
2ms
Enrollment closed • Combination therapy • IO biomarker
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • cyclophosphamide • Calquence (acalabrutinib)
2ms
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=80, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
2ms
Trial completion date
|
Rituxan (rituximab) • lenalidomide • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)
2ms
Trial completion date • Adverse events
|
Venclexta (venetoclax) • Gazyva (obinutuzumab)
2ms
Enrollment closed • Trial primary completion date • Combination therapy
|
Gazyva (obinutuzumab) • Aliqopa (copanlisib)
2ms
New P2 trial
|
Gazyva (obinutuzumab)
2ms
Trial completion • Trial completion date • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2)
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • Gazyva (obinutuzumab) • cyclophosphamide • bendamustine • fludarabine IV
2ms
ORION: Obinutuzumab in Primary MN (clinicaltrials.gov)
P2, N=20, Active, not recruiting, Mario Negri Institute for Pharmacological Research | Recruiting --> Active, not recruiting
Enrollment closed
|
Rituxan (rituximab) • Gazyva (obinutuzumab)
2ms
17P.176: Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas (clinicaltrials.gov)
P2, N=30, Recruiting, Sidney Kimmel Cancer Center at Thomas Jefferson University | Trial completion date: Dec 2023 --> Feb 2031
Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1)
|
Imbruvica (ibrutinib) • Gazyva (obinutuzumab)
2ms
Low incidence of tumor lysis syndrome in elderly patients with chronic lymphocytic leukemia treated with venetoclax under real-world conditions: results from the prospective observational VeRVe study. (PubMed, Ann Hematol)
Patient demographics, baseline characteristics, and blood chemistry at baseline were documented, and descriptive statistical analyses were conducted.Seventy eight patients (33%) were treated with venetoclax monotherapy, 101 (42%) with venetoclax in combination with rituximab and 60 (25%) with venetoclax in combination with obinutuzumab. There were no deaths due to a TLS event and venetoclax was well-tolerated. Of the 5 clinical TLS events reported, none were fatal or resulted in renal failure (NCT03342144, registered on Nov 10, 2017).
Observational data • Journal • Real-world evidence • Real-world
|
IGH (Immunoglobulin Heavy Locus)
|
IGH mutation
|
Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab)
2ms
New P3 trial
|
Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • prednisone • bendamustine • Lunsumio (mosunetuzumab-axgb)
2ms
Trial completion date • Trial primary completion date • Combination therapy
|
TNFA (Tumor Necrosis Factor-Alpha)
|
carboplatin • Rituxan (rituximab) • Gazyva (obinutuzumab) • ifosfamide • etoposide IV • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
2ms
Enrollment open
|
BCL2 (B-cell CLL/lymphoma 2)
|
BCL2 positive
|
Gazyva (obinutuzumab)