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

LONG TERM FOLLOW-UP OF UNTREATED/RELAPSING MCL PATIENTS WITH THE IBRUTINIB, OBINUTUZUMAB, AND VENETOCLAX COMBINATION. (EHA 2023) - 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... The Ibrutinib-Venetoclax-Obinutuzumab triplet is associated with a sustained disease control, in both R/R (4-y PFS of 50%) and newly diagnosed (4y-PFS of 80%) patients presenting with high risk-profiles (no low-MIPI patients were included in the Oasis Trial). The anti-CD20+Ibrutinib vs anti-CD20+Ibrutinib+Venetoclax combinations are currently under investigation in OASIS-II trial (NCT04802590) for untreated patients with MCL. Venetoclax, ibrutinib, Targeted therapy, Mantle cell lymphoma"

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

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

Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Prespecified Analysis of the Pivotal Phase II Study ELM-2 (ASH 2022) - P1, P2 | "All CRS events resolved with supportive measures; 20% of pts received tocilizumab and none required vasopressors or mechanical ventilation for CRS management. The 0.7/4/20 odronextamab step-up dose regimen for C1 mitigates the risk of high-grade CRS, which has been observed consistently with other bispecifics and CAR T therapies and may present an important future option for the management of pts with R/R DLBCL. Updated safety and efficacy data will be presented."

Clinical • P2 data • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Odronextamab in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1–3a: Results from a Prespecified Analysis of the Pivotal Phase II Study ELM-2 (ASH 2022) - P1, P2 | "All CRS events resolved and only 1 pt received tocilizumab for CRS management. Odronextamab may represent an important treatment option for R/R FL, providing a more accessible option with favorable benefit/risk compared with existing therapies including CAR T cell therapy. Updated safety and efficacy data will be presented."

Clinical • P2 data • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Novel Coronavirus Disease • Oncology

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

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

First-line odronextamab (Odro) plus chemotherapy (CHOP) in diffuse large B-cell lymphoma (DLBCL): OLYMPIA-3 Part 1B results. (ASCO 2026) - P3 | "Clinical Trial Registration Number: NCT06091865 Background: Approximately 25% of patients (pts) treated with rituximab + CHOP do not have a complete response (CR), and those with refractory/relapsed disease or high-risk features have poor outcomes. In Part 1B of OLYMPIA-3, the safety profile of Odro-CHOP was generally manageable and preliminary efficacy was encouraging with no meaningful differences between regimens, and combination with Odro did not impact the delivery of CHOP. Given these results, the less frequent Odro dosing regimen (R2) with CHOP was selected as the recommended Phase 3 dose for Part 2 (randomized controlled trial). Biomarker data will be presented."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Septic Shock • CD20

Odronextamab, a human CD20×CD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial. (PubMed, Lancet Haematol) - P1 | "Odronextamab monotherapy showed a manageable safety profile and encouraging preliminary activity, including durable responses in heavily pretreated patients with B-cell non-Hodgkin lymphoma, supporting further clinical investigation in phase 2 and 3 trials."

Journal • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Renal Disease • Respiratory Diseases • Thrombocytopenia • CD20

ODRONEXTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): RESULTS FROM A PRESPECIFIED ANALYSIS OF THE PIVOTAL PHASE II STUDY ELM-2 (ICML 2023) - P1, P2 | "In the ELM-2 trial, odronextamab showed clinically meaningful efficacy, durable CRs, and a manageable safety profile. These data confirm the efficacy of odronextamab in hard-to-treat, highly aggressive R/R DLBCL. The 0.7/4/20 odronextamab step-up regimen mitigates the risk of high-grade CRS, which is consistently observed with other bispecifics and CAR T therapies, and may present an important future option for the management of R/R DLBCL."

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

ODRONEXTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (FL) GRADE 1–3A: RESULTS FROM A PRESPECIFIED ANALYSIS OF THE PIVOTAL PHASE II STUDY ELM-2 (ICML 2023) - P1, P2 | "In the ELM-2 study, odronextamab demonstrated compelling efficacy in pts with R/R FL, and an acceptable safety profile with the optimized 0.7/4/20 step-up regimen. For this patient population, where prognosis is typically poor, odronextamab may provide a more accessible option with favorable benefit:risk compared with existing therapies. Encore Abstract—previously submitted to EHA 2023"

Clinical • P2 data • Follicular Lymphoma • Hematological Malignancies • 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

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

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

Health-related quality of life (HRQoL), functioning, and symptoms with odronextamab monotherapy in patients (pts) with relapsed or refractory follicular lymphoma (R/R FL) by POD24 status in the ELM-2 study. (ASCO 2024) - P2 | "In pts with heavily pretreated R/R FL, odronextamab Tx maintained HRQoL, functioning, and symptoms irrespective of POD24 status. Clinical trial information: NCT03888105. >Minimal important difference thresholds: EORTC QLQ-C30 = 10; FACT-Lym LymS = 2."

Clinical • HEOR • Monotherapy • Fatigue • Follicular Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Oncology

PRIMARY ANALYSIS OF THE PHASE 2 ELM-2 STUDY: ODRONEXTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (EHA 2024) - P2 | "Odronextamab demonstrated deep and durable responses in heavily pretreated patients with R/R FL; 91% ofresponders achieved CR, correlating with favorable PFS and OS at 24 mo. Odronextamab had a generallymanageable safety profile with a low incidence of Gr 3 CRS and any-grade ICANS. Odronextamab could offeran important off-the-shelf treatment option for patients with heavily pretreated R/R FL."

Clinical • P2 data • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Novel Coronavirus Disease • Oncology

Efficacy and Safety of Odronextamab in Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL): Data from the R/R MZL Cohort in the ELM-2 Study (ASH 2024) - P2 | "Odronextamab may be an important potential treatment option in the future management of R/R MZL, and these results support the continued investigation of odronextamab in Phase 3 trials. Updated data will be presented."

Clinical • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Efficacy and Safety of Odronextamab Monotherapy in Patients (Pts) with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing after CAR T-Cell Therapy: Primary Analysis from the ELM-1 Study (ASH 2024) - P1 | "Prior CAR T-cell therapies were axi-cel (50%), tisa-cel (12%), liso-cel (10%), and not specified (28%). Odronextamab monotherapy was associated with encouraging efficacy and generally manageable safety in a setting with limited treatment options and historically dismal outcomes. Efficacy was observed even in pts relapsing in ≤90 D, supporting the potential of odronextamab as an accessible, off-the-shelf option in the post-CAR T setting."

CAR T-Cell Therapy • Clinical • Monotherapy • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Epilepsy • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • CD20 • CD69

Long-Term Efficacy and Safety of Odronextamab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Pooled Analysis from the ELM-1 and ELM-2 Studies (ASH 2024) - P1, P2 | "Odronextamab may be an important potential option in future management of R/R DLBCL, and Phase 3 trials are ongoing. Updated data will be presented."

Retrospective data • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pancreatitis • CD20

Efficacy and Safety of Odronextamab in Rare Subtypes of Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL): Data from a Dedicated Cohort of Other B-NHLs in the ELM-2 Study (ASH 2024) - P2 | "These findings support the potential role of odronextamab in the treatment paradigm for rare subtypes of R/R aggressive B-NHL. Updated data, including efficacy in each subtype, will be presented."

Clinical • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Mediastinal B Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • T Cell Histiocyte Rich Large B Cell Lymphoma • BCL2 • BCL6 • CD20

Odronextamab Monotherapy in Previously Untreated Patients with High-Risk Follicular Lymphoma (FL): Results of the Safety Lead-in of the Phase 3 Olympia-1 Study (ASH 2024) - P2, P3 | "Preliminary efficacy data were promising, with 100% of response-evaluable pts achieving CR at the Week 12 assessment. Updated data, including efficacy and preliminary biomarker data in pts from Part 1, will be presented."

Clinical • IO biomarker • Monotherapy • P3 data • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology • CD20

Odronextamab monotherapy in patients with relapsed/refractory diffuse large B cell lymphoma: primary efficacy and safety analysis in phase 2 ELM-2 trial. (PubMed, Nat Cancer) - P2 | "In conclusion, odronextamab showed encouraging efficacy in heavily pretreated R/R DLBCL and generally manageable safety with supportive care. Clinical trial registration: NCT03888105 ."

Journal • Monotherapy • P2 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CD20

Odronextamab monotherapy in R/R DLBCL after progression with CAR T-cell therapy: Primary analysis of the ELM-1 study. (PubMed, Blood) - P1 | "Odronextamab monotherapy demonstrated encouraging efficacy and generally manageable safety, supporting its potential as an off-the-shelf option for post-CAR T patients. This trial was registered at www.clinicaltrials.gov as #NCT02290951."

Journal • Monotherapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • CD20

LONG-TERM EFFICACY AND SURVIVAL OUTCOMES WITH ODRONEXTAMAB FOR PATIENTS (PTS) WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (R/R FL): 2-YEAR FOLLOW-UP FROM THE PHASE 2 ELM-2 STUDY (EHA 2025) - P2 | "With longer follow-up, odronextamab demonstrated deep, durable responses in heavily pretreated pts with R/R FL from ELM-2; 80% of pts were responders, 92% of whom had a CR, and median DOCR was 32 mo with a median OS of >4 years. Robust efficacy was seen in pts with high-risk features, and odronextamab had a generally manageable safety profile. These results suggest that high CR rates with durability may confer long-term survival benefit in heavily pretreated pts with R/R FL and support the potential role of odronextamab in this setting."

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

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

Safety and Efficacy of Odronextamab in Relapsed/Refractory B-Cell Lymphomas: A Living Systematic Review With Subtypes and Post–CAR-T Analysis (SOHO 2026) - "Exploratory matching-adjusted indirect comparison (MAIC) with epcoritamab was reviewed where available. Odronextamab demonstrates durable efficacy in R/R B-NHL, including in post-CAR-T settings. While step-up dosing mitigates high-grade CRS, infectious complications remain unresolved challenges. Early ctDNA clearance may serve as a predictive biomarker of long-term outcomes."

CAR T-Cell Therapy • Clinical • IO biomarker • Review • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20