Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Obinutuzumab · 1 trial · 1 indication
The primary efficacy endpoint is the PFS at 12 months (end of C17) from first dose of study treatment, in each cohort: Zanubrutinib/Venetoclax/Glofitamab for cohorts A and C, Venetoclax/Glofitamab for cohort B, as determined by imaging central review (Lugano 2014 criteria),
| Arm | Type | Description |
|---|---|---|
| Cohort A - POD24 | EXPERIMENTAL | * Obinutuzumab IV infusion 2000 mg flat dose at C1D1 or Splited in 2 doses of 1000 mg at C1D1 and C1D2 * Glofitamab IV infusion 2.5 mg C1D8 10 mg C1D15 30 mg C2D1 and C3D1 (infusion during min 4 hours ) 30 mg Each D1 for C4 to C6 (Infusion during min 2 hours ) 30 mg Each D1 for C7 to C12 (Infusion during min 90 min) * Zanubrutinib PO 320 mg total daily dose (QD) From C1D2 continuously until end C35 * Venetoclax PO 20 mg/d C2D3 to C2D7 50 mg/d C2D8 to C2D14 100 mg/d C2D15 to C2D21 200 mg/d C3D1 to C3D7 400 mg/d From C3D8 continuously until end C35 |
| Cohort B - BTKI failure | EXPERIMENTAL | * Obinutuzumab IV infusion 2000 mg flat dose at C1D1 or Splited in 2 doses of 1000 mg at C1D1 and C1D2 * Glofitamab IV infusion 2.5 mg C1D8 10 mg C1D15 30 mg C2D1 and C3D1 (infusion during min 4 hours ) 30 mg Each D1 for C4 to C6 (Infusion during min 2 hours ) 30 mg Each D1 for C7 to C12 (Infusion during min 90 min) * Venetoclax PO 20 mg/d C2D3 to C2D7 50 mg/d C2D8 to C2D14 100 mg/d C2D15 to C2D21 200 mg/d C3D1 to C3D7 400 mg/d From C3D8 continuously until end C35 |
| Cohort C - first Line | EXPERIMENTAL | * Obinutuzumab IV infusion 2000 mg flat dose at C1D1 or Splited in 2 doses of 1000 mg at C1D1 and C1D2 * Glofitamab IV infusion 2.5 mg C1D8 10 mg C1D15 30 mg C2D1 and C3D1 (infusion during min 4 hours ) 30 mg Each D1 for C4 to C6 (Infusion during min 2 hours ) 30 mg Each D1 for C7 to C12 (Infusion during min 90 min) * Zanubrutinib PO 320 mg total daily dose (QD) From C1D2 continuously until end C35 * Venetoclax PO 20 mg/d C2D3 to C2D7 50 mg/d C2D8 to C2D14 100 mg/d C2D15 to C2D21 200 mg/d C3D1 to C3D7 400 mg/d From C3D8 continuously until end C35 |
| Name | Type | Description |
|---|---|---|
| Obinutuzumab | DRUG | 1000 mg/40mL |
| Glofitamab | DRUG | 10mg/mL |
| Venetoclax Oral Product | DRUG | 10mg, 50mg and 100mg tablets |
| Zanubrutinib Oral Capsule | DRUG | 80mg capsules |
Inclusion Criteria: In cohort A, subject must meet the following inclusion criteria: 1. Subject must be primary refractory or in progression within 24 months from initiation of first line treatment (POD24 defined as time between D1C1 of the first treatment line and ICF signature)) (including an an...
Obinutuzumab is an investigational antibody being studied for the treatment of mantle-cell lymphoma, a type of non-Hodgkin lymphoma. It is currently in Phase 2 clinical development for this indication, with an ongoing trial evaluating its use in combination with other agents in high-risk mantle-cell lymphoma patients.
Obinutuzumab is a monoclonal antibody, classified as a -mab (antibody) modality. It is designed to target CD20, a protein found on the surface of B-cells, which are the malignant cells in mantle-cell lymphoma. By binding to CD20, the antibody aims to direct the immune system to destroy these cancer cells.
Obinutuzumab is being developed by BeOne Medicines Ltd., a biopharmaceutical company traded under the ticker symbol ONC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with mantle-cell lymphoma.
Obinutuzumab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to assess its potential as a treatment for high-risk mantle-cell lymphoma.
Obinutuzumab is being studied in a Phase 2 clinical trial registered as NCT06558604. This trial, titled 'Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma,' is recruiting 100 participants in Belgium and France. The study is controlled but not randomized or double-blinded, and it uses biomarker selection.
No, Obinutuzumab is not the same as Glofitamab. Obinutuzumab is the drug being developed by BeOne Medicines Ltd. and is the subject of this profile. Glofitamab is a separate investigational agent that is being combined with other drugs in the clinical trial NCT06558604, which includes Obinutuzumab as part of the treatment regimen.