Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Odronextamab · 1 trial · 1 indication
Occurrence of an objective response (OR) i.e. Complete Response (CR) or Partial Response (PR) after 12 weeks of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)
Occurrence of CR within a maximum of three cycles of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)
| Arm | Type | Description |
|---|---|---|
| Treatment Arm I - BsAb - Odronextamab | EXPERIMENTAL | Patients will receive odronextamab given as an intravenous infusion weekly for 12 weeks, then every two weeks until nine months, and every four weeks thereafter until progression or for a maximum of two years |
| Treatment Arm II - ADC with Standard Chemotherapy - Loncastuximab tesirine with modified R-ICE | EXPERIMENTAL | Patients will receive loncastuximab tesirine given as a 30-minute intravenous infusion with each cycle of modified R-ICE (maximum three cycles) |
| Treatment Arm III - CAR T-cells - TBC | EXPERIMENTAL | Patients will receive CAR-T cell therapy - agent TBC |
| Name | Type | Description |
|---|---|---|
| Odronextamab | DRUG | CD20xCD3 bispecific antibody |
| Loncastuximab tesirine | DRUG | CD-19-directed antibody-drug conjugate |
| Rituximab | DRUG | Modified R-ICE chemotherapy |
| Ifosfamide | DRUG | Modified R-ICE chemotherapy |
| Carboplatin | DRUG | Modified R-ICE chemotherapy |
| Etoposide | DRUG | Modified R-ICE chemotherapy |
| Etoposide Phosphate | DRUG | Modified R-ICE (Treatment Arm II) |
| Dexamethasone | DRUG | Modified R-ICE chemotherapy |
| CAR T-cells (TBC) | BIOLOGICAL | Modified R-ICE chemotherapy |
Inclusion criteria applicable to all treatment arms: * Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma/Leukaemia or atypical Burkitt/Burkitt-like lymphoma, primary mediastinal large B-cell lymphoma (PMLBL), and mature B-NHL/Not Otherwise Specified (NOS)) ...
Odronextamab is an investigational small molecule being studied for the treatment of B-cell Non Hodgkin Lymphoma. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in patients with relapsed and refractory disease.
Odronextamab targets MS4A1, CD3E, CD3G, and CD3D. MS4A1 is a B-cell surface antigen, while the CD3 molecules are part of the T-cell receptor complex. This binding agent is designed to engage both B-cells and T-cells in the context of B-cell Non Hodgkin Lymphoma.
Odronextamab is being developed by ADC Therapeutics SA, a biopharmaceutical company traded under the ticker ADCT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with B-cell Non Hodgkin Lymphoma.
Odronextamab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is actively recruiting participants to assess the drug's effects in the intended patient population.
Odronextamab is being evaluated in a Phase 2 clinical trial registered as NCT05991388. This study is titled 'A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma' and is currently recruiting participants across multiple countries including Australia, Austria, Belgium, the Netherlands, New Zealand, Sweden, and the United Kingdom.