Ordspono (odronextamab) / Regeneron, ZAI Lab - LARVOL DELTA

Hematotoxicity and immune deficits with bispecific antibodies: A systematic review and meta-analysis in lymphoma and multiple myeloma (ASH 2025) - "Among NHL cohorts, the BsAb distribution was: 7 glofitamab, 6 mosunetuzumab, 5 epcoritamab, and 4 odronextamab. Among MM cohorts, 6 received teclistamab, 3 talquetamab, 1 teclistamab and talquetamab, 2 elranatamab, 2 linvoseltamab and 1 etentamig (ABBV-383)... Cytopenias affect a substantial proportion of patients treated with BsAbs, particularly in MM and in NHL with combination regimes. These findings support the need for systematic hematologic monitoring, IG surveillance and tailored pre-emptive strategies to mitigate infection risk.This study represents the first and most comprehensive meta-analysis of hematotoxicity and immune deficits with BsAbs, establishing a benchmark across clinical settings."

Retrospective data • Review • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

Incidence of second primary malignancies (SPMs) following bispecific antibody (BsAb) therapy for lymphoid malignancies: A descriptive analysis of clinical trials (ASH 2025) - "Included agents were blinatumomab (CD19×CD3), glofitamab, mosunetuzumab, epcoritamab, and odronextamab (all CD20×CD3), as well as elranatamab, teclistamab, and linvoseltamab (BCMA×CD3), and talquetamab (GPRC5DxCD3). Notably, some reported cases may represent disease progression rather than true SPMs. However, limited follow-up duration across trials warrants continued long-term surveillance, particularly as agents move to frontline settings where longer survival may reveal delayed malignancies."

Clinical • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lung Cancer • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Effectiveness and safety of bispecific antibodies in relapsed/refractory diffuse large B-cell lymphoma (DLBCL): A systematic review and meta-analysis (ASH 2025) - " Twelve eligible studies involving 744 patients were included, primarily evaluating glofitamab (6 studies), epcoritamab (2), mosunetuzumab (2), and odronextamab (2). Bispecific antibodies offer a promising therapeutic approach for relapsed/refractory DLBCL, particularly in heavily pretreated or CAR-T-ineligible patients. These findings support their expanding role in clinical practice and highlight the need for further real-world evidence. Multi-national randomized controlled trials with longer follow-up are needed to establish durability and optimize treatment sequencing."

Retrospective data • Review • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma

Odronextamab (Odro) plus lenalidomide (+Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): First results from part 1 (safety lead-in) of the Phase 3 OLYMPIA-5 study (ASH 2025) - P2, P3 | "OLYMPIA-5 consists of Part 1 (safety lead-in)and Part 2 (Odro+Len vs rituximab+Len). Conclusions Odro+Len showed generally manageable safety and encouraging preliminary efficacy in pts with R/R FLafter ≥1 prior LOT in OLYMPIA-5. Updated data will be presented."

Clinical • P3 data • Cardiovascular • Cerebral Hemorrhage • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Respiratory Diseases • CD20 • CD4 • CXCL8 • IFNG • IL6

Odronextamab treatment for patients with rare subtypes of relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL): Updated efficacy and safety analyses from a dedicated cohort of the ELM-2 study (ASH 2025) - P2 | "Odronextamab retained a generallymanageable safety profile with continued treatment, and no new safety signals were recorded over thislonger follow-up period. Updated data, including ICR-assessed response and biomarker analyses, will bepresented."

Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Mediastinal B Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma

Phased variant circulating tumor DNA (ctDNA) tracking provides limited additional power in predicting progressive disease compared with duplex variant tracking in patients with Relapsed/Refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) treated with odronextamab (ASH 2025) - P2 | "Eachapproach has specific benefits, but both appear appropriate for MRD assessment, notably in pts withDLBCL. Further analyses of these methods across B-NHL subtypes are required to discern their relativeadvantages."

Circulating tumor DNA • Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Severe neutropenia after treatment with T-cell engaging bispecific antibodies is associated with higher rates of CRS and disease response (ASH 2025) - "BsAbsprescribed included teclistamab (n = 80, 40%), talquetamab (n = 38, 19%), epcoritamab (n = 34, 17%),elranatanab (n = 25, 13%), mosunetuzumab (n = 14, 7%), odronextamab (n = 6, 3%) and glofitamab (n = 2,1%). The absence of improved survivaloutcomes could be due to higher rates of toxicity-related treatment discontinuation. Future studiesaimed at prevention and mitigation of BsAb-associated cytopenias while avoiding impacting diseasecontrol could improve outcomes of patients treated with this modality."

B Cell Non-Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

Odronextamab plus chemotherapy in patients with previously untreated follicular lymphoma: First results from part 1 of the Phase 3 Olympia-2 study (ASH 2025) - P3 | "OLYMPIA-2 (NCT06097364), a Phase 3, randomized,open‑label, multicenter study, is the first to assess whether Odro + chemotherapy (CHOP/CVP) induction± Odro maintenance is superior to standard-of-care rituximab (R) + CHOP/CVP induction + R maintenancein pts with previously untreated FL (Part 2). Preliminary efficacy was promising, with CR rates of 78% for DL1and 86% for DL2. Updated Part 1A data, including biomarkers, will be presented."

Clinical • P3 data • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Pneumonia • Respiratory Diseases • CD20 • CXCL8 • IFNG • IL6 • TNFA

Efficacy and safety of long-term odronextamab treatment in patients with relapsed/refractory follicular lymphoma: 3-year follow-up from the Phase 2 ELM-2 study (ASH 2025) - P2 | "The safety profile remained generallymanageable, with no new safety signals observed, and no evidence of increased infection risk in pts whoswitched to Q4W maintenance. Updated data will be presented."

Clinical • P2 data • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • CD20

Anti-CD3/CD20 bispecific antibodies as salvage therapy after CAR-T failure in Relapsed/Refractory large B-cell lymphoma: A systematic review and meta-analysis (ASH 2025) - "Anti-CD3/CD20 BsAbs commonly usedto treat LBCL include Glofitamab (30.9%), Odronextamab (21.5%), Epcoritamab (22.2%), andMosunetuzumab (22.2%).The pooled ORR rate was 45% (95%CI, 37–53), including a CR rate of 30% (95% CI, 25–35) and a PR rate of18% (95%CI, 15–22). Hematologic toxicities were also commonly reported.Neutropenia occurred in 34.2% of patients (Grade ≥3: 22.8%), anemia in 30.0% (Grade ≥3: 13.2%), andthrombocytopenia in 23.3% (Grade ≥3: 6.5%).ConclusionBsAbs demonstrate durable efficacy and manageable safety in patients with R/R LBCL following CAR-Ttherapy failure. Additionally, a longer treatment interval between CAR-T and bispecific antibodies wasassociated with better efficacy and survival."

Retrospective data • Review • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases

Infection risk factors and burden in patients treated with T-cell engaging bispecific antibodies for relapsed B-cell lymphoma and multiple myeloma (ASH 2025) - "The incidence of grade≥ 3 infections varied among patients treated with different BsAbs (p<0.05):odronextamab (4/6, 67%), elranatamab (10/25, 40%), epcoritamab (13/34, 38%) teclistamab (22/81, 27%),talquetamab (6/38, 16%), mosunetuzumab (2/14, 14%). No grade 3 or higher infections were reportedwith glofitamab (0/2)...Theoccurrence of CRS did not predispose to higher grade ≥ 3 infection risk (p=0.8) and neither didadministration of tocilizumab (p=0.5)...Our results highlight the effect of IVIG, and this measure shouldbe considered in hypogammaglobulinemic patients. While non-bacterial infection prophylaxis wascommon, half of the infections were presumed or demonstrated to be bacterial, and prospectiveevaluation of antibacterial prophylaxis should be considered for high-risk patients."

Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

Odronextamab plus chemotherapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): First Results from part 1 of the Phase 3 Olympia-3 study (ASH 2025) - P2, P3 | "Introduction Odronextamab (Odro), a CD20×CD3 bispecific antibody, has shown compelling efficacy as monotherapyin patients (pts) with relapsed/refractory (R/R) DLBCL in the Phase 2 ELM-2 study (NCT03888105).OLYMPIA-3 (NCT06091865), a Phase 3, randomized, open-label, multicenter study, is the first toinvestigate whether Odro + chemotherapy (CHOP) is superior to standard-of-care rituximab + CHOP inpts with previously untreated DLBCL (Part 2). Preliminary efficacy of this simplified regimen was encouraging,with a CR rate of 100% for DL2, suggesting that rituximab may not be required to achieve depth ofresponse when combining Odro with CHOP in previously untreated pts with DLBCL. Updated Part 1A datawill be presented."

Clinical • IO biomarker • P3 data • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Lymphoma • Myocardial Infarction • Neutropenia • Non-Hodgkin’s Lymphoma • Septic Shock • BCL2 • BCL6 • CD20 • CXCL8 • IFNG • IL6 • MYC • TNFA

The Therapeutic Value of Bispecific Antibodies in Hematology: Analysis of Health Technology Assessments From Three European Countries (ISPOR-EU 2025) - "The added therapeutic value (ATV) was obtained from the official HTA documents of the Haute Autorité de santé (HAS), the Federal Joint Committee or Gemeinsamer Bundesausschuss (G-BA), and the Italian Medicines Agency (AIFA). We identified eight bsAbs for hematological diseases, mosunetuzumab, glofitamab, epcoritamab, and odronextamab for lymphoma, teclistamab, elranatamab, and talquetamab for multiple myeloma and blinatumomab for acute lymphoblastic B-cell leukemia (B-ALL). ATV is crucial for defining the place in therapy of drugs at the national level, and patients' access. The present study shows the alignment of the three agencies in assessing the value of bsAbs approved for hematological malignancies, with a lack of recognition of ATV for most of the indications. Further analysis will be carried out to assess the reasons and the consequences in terms of access."

Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Pediatrics

The first results from a small cohort of patients enrolled in part 1 of the phase 3 OLYMPIA-3 study were presented at the 2025 ASH Annual Meeting. (Cure Today) - "In the early results, the objective response rate (ORR) was 78% with the weekly 80 milligram dose of odronextamab plus CHOP and was 100% for the weekly 160 milligram dose of odronextamab plus CHOP. The complete response rates were 44% and 100% for each dose, respectively. The median duration of response, duration of complete response and progression-free survival were not yet reached at the early analysis."

P3 data • Diffuse Large B Cell Lymphoma

Pharmacokinetics of Odronextamab, A Bispecific T-Cell-Engaging Antibody, in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. (PubMed, CPT Pharmacometrics Syst Pharmacol) - P1, P2 | "Target-mediated clearance was ~5 L/day at baseline, with an asymptote of ~0.03 L/day at steady state. With the largest covariate effect on odronextamab exposure, baseline body weight was directly correlated with CL and volume of distribution, albumin was inversely correlated with CL and volume of distribution, and baseline interleukin-10 was inversely correlated with CL."

Journal • PK/PD data • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • IL10

5-y Follow-up of Combination of Ibrutinib, Obinutuzumab and Venetoclax for Patients with Newly Diagnosed Mantle Cell Lymphoma, the Oasis Trial (ASH 2024) - P1/2, P2 | "Patients who progressed were treated with Bendamustine-containing regimen (6 out of 10) and one patient received Odronextamab and anti-CD22xCD3 bispecific antibodies...Two patients prematurely discontinued the treatment, one patient had a PD at C4 and has subsequently been treated with R-CHOP, one patient relapsed after treatment completion and has been treated with Glofitamab...Conclusion : The Ibrutinib-Venetoclax-Obinutuzumab triplet is associated with a highl and sustained disease control in newly diagnosed (5y-PFS of 80%) patients presenting with high risk-profiles. The anti-CD20+Ibrutinib vs anti-CD20+Ibrutinib+Venetoclax combinations are currently under investigation in OASIS-II trial (NCT04802590) for untreated patients with MCL and may represent a bona-fide alternative to Chemo-based treatments."

Clinical • Atrial Fibrillation • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Oncology • Rare Diseases • TP53

Trial in Progress: Phase 1 Trial Evaluating the Safety and Tolerability of Odronextamab in Combination with Cemiplimab in Relapsed/Refractory Aggressive B‑Cell Non-Hodgkin Lymphoma (ASH 2023) - P1 | "Secondary endpoints include pharmacokinetics, immunogenicity, and preliminary anti-tumor activity (overall response rate, CR rate, and DoR, according to the Lugano classification). There are no formal hypotheses for this study and analyses will be descriptive in nature."

Clinical • Combination therapy • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Immunology • Indolent Lymphoma • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

A Systematic Literature Review (SLR) and Meta-Analysis of Clinical Evidence of Second Line or Later (2L+) Treatments for Follicular Lymphoma (FL) in Adult Patients (ASH 2023) - "Eligible treatments included CAR T cell therapies (axicabtagene ciloleucel, lisocabtagene maraleucel, and tisagenlecleucel), T cell engagers (mosunetuzumab, glofitamab, epcoritamab, odronextamab), phosphatidylinositol 3-kinase (PI3K) inhibitors (copanlisib, duvelisib, idelalisib), HSCT, yttrium-90 (90Y) ibritumomab tiuxetan, tazemetostat, and conventional therapies (immunochemotherapies, single- or multiagent chemo- or immunotherapies, and alkylating agents). This SLR demonstrated an evolving FL treatment landscape, with new agents such as CAR T cell therapies and T cell engagers exhibiting potential for improving effectiveness of treatment for patients in 3L+, 4L+, and 2L+ POD24 populations."

Retrospective data • Review • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Health-Related Quality of Life and Symptoms in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with Odronextamab Monotherapy in the Phase 2 ELM-2 Study (ASH 2023) - P2 | "Odronextamab treatment until disease progression may have benefits on HRQoL for heavily pretreated patients with R/R DLBCL and potentially addresses unmet needs in a challenging treatment setting. Collection of PROs was consistently high and the results offer important patient-centered insights into the overall benefit-risk profile of odronextamab in R/R DLBCL."

Clinical • HEOR • Monotherapy • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Odronextamab Demonstrates Durable Complete Responses in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing after CAR-T Therapy: Outcomes from the ELM-1 Study (ASH 2023) - P1 | "These data support the potential role of odronextamab in the treatment paradigm for R/R DLBCL. Further studies to evaluate the optimal sequencing and combinations of odronextamab with CAR-T therapy are warranted."

Clinical • IO biomarker • B Cell Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • CD20

What is established in the treatment of diffuse large B-cell lymphoma? (PubMed, Inn Med (Heidelb)) - "First-line standard therapy is R‑CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), de-escalated to four cycles for young, low-risk patients (FLYER trial)...In relapsed/refractory disease, chimeric antigen receptor (CAR) T‑cell therapy with axicabtagene ciloleucel or lisocabtagene maraleucel has replaced high-dose chemotherapy with autologous stem cell transplantation for refractory or early relapses, including transplant-ineligible patients. Additional antibody-based therapies-such as polatuzumab-bendamustine-rituximab, tafasitamab-lenalidomide, loncastuximab, and bispecific antibodies (glofitamab, epcoritamab, odronextamab)-expand treatment options, some achieving durable remissions. Glofitamab plus gemcitabine-oxaliplatin is a new standard for first relapse when CAR T‑cell therapy is not feasible or as bridging before CAR T. Future directions include earlier integration of immunotherapies, personalized strategies guided by genetic..."

Journal • Review • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-Cell Non-Hodgkin Lymphoma (Glo-BNHL) (ASH 2023) - "Treatment Treatment Arm I: Odronextamab (Regeneron) – a human CD20xCD3 bispecific antibody – monotherapy will be given as an intravenous infusion weekly for 12 weeks, then at a decreasing frequency until progression or up to two years for responding patients. Treatment Arm II: Loncastuximab tesirine (ADC Therapeutics) – a humanised CD19-targeting monoclonal antibody with PBD dimer cytotoxin – will be given as an intravenous infusion with each cycle of modified R-ICE chemotherapy (rituximab, ifosfamide, carboplatin, etoposide and dexamethasone) for up to three cycles. Treatment Arm III: product negotiations are on-going Conclusion Glo-BNHL addresses an urgent unmet clinical need through an innovative trial design serving as a paradigm for evaluation of novel agents in very rare diseases."

Clinical • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Primary Immunodeficiency • Rare Diseases

Results of a Second, Prespecified Analysis of the Phase 2 Study ELM-2 Confirm High Rates of Durable Complete Response with Odronextamab in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) with Extended Follow-up (ASH 2023) - P2 | "All CRS events resolved with supportive measures; 13 pts received tocilizumab for CRS management with the optimized regimen. These data underscore the promise of odronextamab as a potentially effective agent for the management of R/R FL. Updated data will be presented."

Clinical • P2 data • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Maintenance of Moderate to High Levels of Functioning and Quality of Life with Odronextamab Monotherapy in Patients with Relapsed or Refractory Follicular Lymphoma (ASH 2023) - P2 | "For patients with R/R FL, patient-reported HRQoL results were favorable during odronextamab treatment until disease progression, with no detriments on patient-reported symptoms, functioning, and overall quality of life. These results complement encouraging clinical efficacy, durability of responses, and tolerability observed in this highly refractory patient population and support the future role of odronextamab in the management of patients with R/R FL."

Clinical • HEOR • Monotherapy • Fatigue • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) (ASH 2023) - P2 | "CRS events resolved with supportive measures; 26% of pts received tocilizumab for CRS management with the optimized regimen. Odronextamab may be an important potential option in future management of R/R DLBCL, and these results support the continued investigation of odronextamab in Phase 3 trials. Updated data will be presented."

Clinical • P2 data • Anemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pancreatitis • Richter's Syndrome