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Adjusted LOA
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Englumafusp alfa · 1 trial · 1 indication
Incidence, nature, and severity of AEs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
| Arm | Type | Description |
|---|---|---|
| Part I | EXPERIMENTAL | Combination Dose-Escalation: Mixed r/r NHL participants will receive a fixed dose of obinutuzumab up to seven days prior to first administration of englumafusp alfa. Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab in a three-weekly schedule (Q3W). |
| Part II | EXPERIMENTAL | Combination Dose-Escalation: Mixed r/r participants and participants with mixed r/r mantle cell lymphoma (MCL) and Richters transformation will receive a fixed dose of obinutuzumab seven days prior to first administration of englumafusp alfa. Englumafusp alfa will be administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W). |
| Part III | EXPERIMENTAL | Dose-Expansion Stage: Participants with r/r diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and DLBCL arising from FL (transformed FL) will receive englumafusp alfa administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W). |
| Name | Type | Description |
|---|---|---|
| Englumafusp alfa | DRUG | Englumafusp alfa will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III). |
| Obinutuzumab | DRUG | A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa, then in combination with obinutuzumab Q3W (Part I). A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa or between Day -3 and -7 (Part II and Part III). |
| Glofitamab | DRUG | A fixed dose of glofitamab will be administered Q3W in combination with englumafusp alfa in Part II and Part III |
| Tocilizumab | DRUG | Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS). |
Inclusion Criteria: * History or status of a histologically-confirmed hematological malignancy that is expected to express CD19 and CD20; relapse after or failure to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival (Part I and II)...
Englumafusp alfa is an investigational oncology therapy being studied for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Englumafusp alfa is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety, pharmacokinetics, and preliminary anti-tumor activity in patients with B-cell non-Hodgkin's lymphoma.
Englumafusp alfa is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants, and the drug remains under evaluation for safety and efficacy.
Englumafusp alfa is being studied in a single Phase 1 clinical trial with the identifier NCT04077723. This trial evaluates the drug in combination with obinutuzumab and with glofitamab following a pre-treatment dose of obinutuzumab in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Yes, Englumafusp alfa is classified as a small molecule modality. It is being developed as an oncology treatment for non-Hodgkin's lymphoma, and its clinical trial is designed as a randomized, controlled study without a double-blind design.
The Phase 1 trial for Englumafusp alfa has a total planned enrollment of 498 participants. It is a randomized, controlled study that is not double-blind. The trial is active but not recruiting, and it includes participants aged 18 years and older across multiple countries.