Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Odronextamab multiple dose levels, REGN1979, Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody REGN1979, WHO 11035, R1979, Ordspono
Odronextamab · 10 trials · 22 indications
Part 1
Part 1
Part 1
Part 2
Part 1A
Part 1
Part 1
Part 2
Part 1
Part 1
Part 1
Part 2
Part 1, DLT period
Part 1, Treatment period
Part 1, Treatment period
Part 2
CRR is defined as the proportion of patients who accomplish a complete response (CR) as best response (CR rate) following treatment with odronextamab as per the revised Lugano criteria.
Will include failures due to disease progression or adverse events (AEs) due to odronextamab (Odron), or requirement of other lymphoma-directed therapy for bridging before leukapheresis due to lack of response. Will report the total number and percentage with 95% confidence interval (CI).
FL grade 1-3a/MZL
DLBCL/MCL/Other B-NHL
A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications).
Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.
Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.
An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.
An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.
Part A and B
Part A and B
Expansion Cohorts: • Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy Part A
| Arm | Type | Description |
|---|---|---|
| Odronextamab | EXPERIMENTAL | Participants will receive odronextamab monotherapy. |
| Standard Of Care | ACTIVE_COMPARATOR | Participants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab \[ICE ± R\], or dexamethasone, cisplatin, cytarabine ± rituximab \[DHAP ± R\], or gemcitabine, dexamethasone, cisplatin ± rituximab \[GDP ± R\]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR). |
| Odronextamab+Lenalidomide | EXPERIMENTAL | In part 1 (safety run-in), participants with R/R indolent lymphoma (FL and MZL), will receive odronextamab in combination with lenalidomide. In part 2, 1:1 randomized participants with R/R FL and MZL, will receive odronextamab in combination with lenalidomide. |
| Rituximab+Lenalidomide | EXPERIMENTAL | In part 2 only, 1:1 randomized participants with R/R FL and ML, will receive rituximab in combination with lenalidomide (R2) followed by lenalidomide monotherapy. |
| Odronextamab + CHOP | EXPERIMENTAL | Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B). |
| Rituximab + CHOP | ACTIVE_COMPARATOR | Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP. |
| Rituximab + Investigator's Choice Chemotherapy | ACTIVE_COMPARATOR | Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance. |
| Odronextamab + Chemotherapy | EXPERIMENTAL | Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL. |
| Rituximab + Chemotherapy | ACTIVE_COMPARATOR | In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance. |
| Odronextamab + Chemotherapy + Maintenance | EXPERIMENTAL | In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy \[CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)\], followed by odronextamab monotherapy maintenance. |
| Odronextamab + Chemotherapy + No maintenance | EXPERIMENTAL | In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance. |
| Treatment (odronextamab) | EXPERIMENTAL | Patients receive odronextamab IV based on the following schedules: * Step-up dosing during cycle 1: 0.2 mg on C1D1, 0.5 mg on C1D2, 2 mg on C1D8 and C1D9, respectively, and 10 mg on C1D15 and C1D16, respectively (0.7/4/20 regimen). * Dosing during cycles 2-4: Odron will be given at 160 mg weekly. * Once every other week at 320 mg of remaining cycles. Please see the Detailed Description for additional information. |
| FL | EXPERIMENTAL | Follicular lymphoma grade 1-3a cohort |
| DLBCL | EXPERIMENTAL | Diffuse large B-cell lymphoma cohort |
| MCL | EXPERIMENTAL | Mantle Cell Lymphoma cohort |
| MZL | EXPERIMENTAL | Marginal Zone Lymphoma cohort |
| Other B-NHL | EXPERIMENTAL | Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia \[WM\]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed |
| Dose escalation portion | EXPERIMENTAL | - |
| Dose expansion portion | EXPERIMENTAL | - |
| Part A | EXPERIMENTAL | DLBCL post CAR-T |
| 1N Part B | EXPERIMENTAL | FL |
| 2N Part B | EXPERIMENTAL | DLBCL |
| Name | Type | Description |
|---|---|---|
| Odronextamab | DRUG | Administered by intravenous (IV) infusion |
| Ifosfamide | DRUG | Administered by IV infusion, as part of the ICE ± R salvage therapy |
| Carboplatin | DRUG | Administered by IV infusion, as part of the ICE ± R salvage therapy |
| Etoposide | DRUG | Administered by IV infusion, as part of the ICE ± R salvage therapy |
| Rituximab | DRUG | Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy. |
| Dexamethasone | DRUG | Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy. |
| Cisplatin | DRUG | Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy. |
| Cytarabine | DRUG | Administered by IV infusion, as part of the DHAP ± R salvage therapy. |
| Gemcitabine | DRUG | Administered by IV infusion, as part of the GDP ± R salvage therapy. |
| Lenalidomide | DRUG | Administered per the protocol |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered IV as part of chemotherapy |
| Doxorubicin | DRUG | Doxorubicin will be administered IV as part of chemotherapy |
| Vincristine | DRUG | Vincristine will be administered IV as part of chemotherapy |
| Prednisone/Prednisolone | DRUG | Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy |
| Bendamustine | DRUG | Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine) |
| Prednisone/Prenisolone | DRUG | Administered orally (PO) |
| Biospecimen Collection | PROCEDURE | Undergo collection of blood and oral or rectal swab samples |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Chimeric Antigen Receptor T-Cell Therapy | BIOLOGICAL | Undergo CAR-T cell therapy |
| Computed Tomography | PROCEDURE | Undergo PET/CT |
| Leukapheresis | PROCEDURE | Undergo leukapheresis |
| Lumbar Puncture | PROCEDURE | Undergo lumbar puncture |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Questionnaire Administration | OTHER | Ancillary studies |
| Biopsy Procedure | PROCEDURE | Undergo tissue biopsy |
| REGN5837 | DRUG | Administered per the protocol |
| Odronextamab multiple dose levels | DRUG | Administered by intravenous (IV) infusion |
Key Inclusion Criteria: 1. Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 2. Have primary refra...
Odronextamab is an investigational monoclonal antibody being studied for B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and other aggressive and indolent B-cell lymphomas. It is in Phase 3 development and is not yet approved for commercial use.
Odronextamab targets MS4A1, also known as CD20, on B cells and the CD3E, CD3G, and CD3D subunits of the T-cell receptor complex. This bispecific binding engages T cells to attack malignant B cells. It is classified as a binding agent.
Odronextamab is developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is running the clinical development program across multiple lymphoma indications.
Odronextamab is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes three active trials, with one completed trial, and total enrollment across studies of approximately 1,590 participants.
Odronextamab is being studied in NCT06230224, a Phase 3 trial in aggressive B-cell non-Hodgkin lymphoma, and NCT06149286, a Phase 3 trial combining it with lenalidomide in follicular and marginal zone lymphoma. Earlier-phase studies include NCT07128641 in low tumor volume follicular lymphoma and NCT06784726 in relapsed or refractory large B-cell lymphomas before CAR-T.
Yes. Odronextamab multiple dose levels refers to the same investigational monoclonal antibody, Odronextamab, developed by Regeneron Pharmaceuticals. The phrase describes the dose-ranging evaluation of the drug across clinical trials rather than a separate product.