Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma
Regeneron Pharmaceuticals (NASDAQ: REGN) presented new data for odronextamab at the ASH Annual Meeting, highlighting promising results across multiple B-cell lymphoma types. In the OLYMPIA-1 trial's safety lead-in, odronextamab achieved complete responses in all 12 evaluable previously untreated follicular lymphoma patients.
The ELM-1 trial's expansion cohort showed 48% objective response rate in diffuse large B-cell lymphoma patients who progressed after CAR-T therapy, with 32% achieving complete response. The ELM-2 trial demonstrated 77% complete response rate in relapsed/refractory marginal zone lymphoma patients.
Odronextamab is currently approved in the EU as Ordspono™ for certain lymphoma indications, with U.S. regulatory resubmission expected in first half of 2025.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha presentato nuovi dati riguardo l'odronextamab durante l'Annual Meeting dell'ASH, evidenziando risultati promettenti in diversi tipi di linfoma a cellule B. Nella fase di sicurezza dell'OLYMPIA-1, l'odronextamab ha raggiunto risposte complete in tutti e 12 i pazienti con linfoma follicolare precedentemente non trattati e valutabili.
Il cohort di espansione dello studio ELM-1 ha mostrato un tasso di risposta obiettivo del 48% nei pazienti con linfoma diffuso a grandi cellule B che sono progrediti dopo la terapia CAR-T, con il 32% che ha ottenuto una risposta completa. Lo studio ELM-2 ha dimostrato un tasso di risposta completa del 77% nei pazienti con linfoma marginale recidivante/refrattario.
L'odronextamab è attualmente approvato nell'UE come Ordspono™ per alcune indicazioni di linfoma, con una nuova presentazione normativa negli Stati Uniti prevista per la prima metà del 2025.
Regeneron Pharmaceuticals (NASDAQ: REGN) presentó nuevos datos sobre el odronextamab en la Reunión Anual de ASH, destacando resultados prometedores en múltiples tipos de linfoma de células B. En la fase de seguridad del ensayo OLYMPIA-1, el odronextamab logró respuestas completas en los 12 pacientes evaluables con linfoma folicular que no habían sido tratados previamente.
El cohorte de expansión del ensayo ELM-1 mostró una tasa de respuesta objetiva del 48% en pacientes con linfoma difuso de células B grandes que progresaron después de la terapia CAR-T, con un 32% logrando respuesta completa. El ensayo ELM-2 demostró una tasa de respuesta completa del 77% en pacientes con linfoma marginal recidivante/refractario.
El odronextamab está actualmente aprobado en la UE como Ordspono™ para ciertas indicaciones de linfoma, y se espera una nueva presentación regulatoria en EE. UU. en la primera mitad de 2025.
레제너론 제약 (NASDAQ: REGN)이 ASH 연례 회의에서 오드로넥타맙에 대한 새로운 데이터를 발표하며 여러 종류의 B세포 림프종에서 유망한 결과를 강조했습니다. OLYMPIA-1 시험의 안전성 선행 연구에서 오드로넥타맙은 치료를 받지 않은 12명의 평가 가능한 여포 림프종 환자 모두에서 완전 반응을 달성했습니다.
ELM-1 시험의 확장 코호트는 CAR-T 요법 후 진행한 미만형 대세포 B림프종 환자에서 48%의 객관적인 반응률을 보여주었으며, 그 중 32%가 완전 반응을 달성했습니다. ELM-2 시험에서는 재발/비만성 경계존 림프종 환자에서 77%의 완전 반응률이 나타났습니다.
오드로넥타맙은 현재 EU에서 특정 림프종 적응증에 대해 Ordspono™로 승인되었으며, 미국의 규제 재심사는 2025년 상반기 중 예상됩니다.
Regeneron Pharmaceuticals (NASDAQ: REGN) a présenté de nouvelles données sur l'odronextamab lors de la réunion annuelle de l'ASH, mettant en avant des résultats prometteurs dans plusieurs types de lymphomes à cellules B. Dans la phase de sécurité de l'essai OLYMPIA-1, l'odronextamab a obtenu des réponses complètes chez tous les 12 patients évaluables atteints de lymphome folliculaire précédemment non traités.
Le cohorte d'expansion de l'essai ELM-1 a montré un taux de réponse objectif de 48 % chez les patients atteints de lymphome diffus à grandes cellules B ayant progressé après une thérapie CAR-T, avec 32 % obtenant une réponse complète. L'essai ELM-2 a démontré un taux de réponse complète de 77 % chez les patients atteints de lymphome marginal récidivant/réfractaire.
L'odronextamab est actuellement approuvé dans l'UE en tant qu'Ordspono™ pour certaines indications de lymphome, avec une nouvelle soumission réglementaire attendue aux États-Unis au cours de la première moitié de 2025.
Regeneron Pharmaceuticals (NASDAQ: REGN) hat beim ASH-Jahrestreffen neue Daten zu Odronextamab vorgestellt und vielversprechende Ergebnisse bei verschiedenen B-Zell-Lymphomtypen hervorgehoben. In der Sicherheitsvorrunde der OLYMPIA-1-Studie erzielte Odronextamab bei allen 12 bewertbaren, zuvor unbehandelten Patienten mit follikulärem Lymphom vollständige Antworten.
Die Erweiterungskohorte der ELM-1-Studie zeigte eine objektive Ansprechrate von 48 % bei Patienten mit diffus großzelligem B-Zell-Lymphom, die nach CAR-T-Therapie Fortschritte gemacht hatten, wobei 32 % eine vollständige Antwort erreichten. Die ELM-2-Studie zeigte eine vollständige Ansprechrate von 77 % bei Patienten mit rezidiviertem/refraktärem marginalen Zonenlymphom.
Odronextamab ist derzeit in der EU als Ordspono™ für bestimmte Lymphom-Indikationen zugelassen, wobei eine erneute Einreichung bei den US-Behörden in der ersten Hälfte des Jahres 2025 erwartet wird.
- Complete response rate of 100% in previously untreated follicular lymphoma patients (OLYMPIA-1 trial)
- 48% objective response rate in DLBCL patients who failed CAR-T therapy (ELM-1 trial)
- 77% complete response rate in relapsed/refractory marginal zone lymphoma (ELM-2 trial)
- EU approval already secured for certain lymphoma indications
- Grade ≥3 adverse events occurred in 46% of OLYMPIA-1 patients
- 77% of ELM-1 patients experienced Grade ≥3 treatment-emergent adverse events
- 83% of ELM-2 patients experienced Grade ≥3 adverse events
- U.S. regulatory approval still pending with resubmission delayed to 2025
Insights
The data presented at ASH for odronextamab demonstrates remarkable clinical potential across multiple B-cell lymphoma indications. The standout results include 100% complete response rate in treatment-naive follicular lymphoma patients and 77% complete response rate in relapsed/refractory marginal zone lymphoma. The post-CAR-T DLBCL data showing 48% objective response rate is particularly significant given the poor prognosis in this setting.
The safety profile appears manageable, with cytokine release syndrome being mostly Grade 1-2 and no reports of ICANS or tumor lysis syndrome in the frontline setting. The European approval and planned U.S. submission in 2025 suggest strong regulatory confidence in the data package. The potential to replace chemotherapy in frontline follicular lymphoma could be paradigm-shifting for the field.
This clinical data significantly strengthens Regeneron's position in the competitive CD20xCD3 bispecific antibody market. With
The robust efficacy data across multiple indications, combined with a manageable safety profile, positions odronextamab favorably against competitors. The planned 2025 FDA submission timeline provides clear regulatory visibility. Strong results in post-CAR-T patients also create a unique market opportunity where few effective options exist.
Odronextamab monotherapy led to complete responses in all patients with previously untreated follicular lymphoma evaluable for efficacy, per initial results from the safety lead-in portion of the confirmatory Phase 3 OLYMPIA-1 trial
Primary analysis from an expansion cohort of the ELM-1 trial highlighted continued efficacy and durability in diffuse large B-cell lymphoma patients whose disease had progressed after CAR-T therapy
First results from the ELM-2 trial in marginal zone lymphoma demonstrated high complete response rate in patients with relapsed/refractory disease
TARRYTOWN, N.Y., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab were presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA. The presentations, including two orals, showcase the depth and breadth of the odronextamab clinical development program, with twelve abstracts spanning several B-cell non-Hodgkin lymphoma (B-NHL) subtypes across earlier lines of treatment.
OLYMPIA-1 Part 1 Results Showcased Compelling Potential in Previously Untreated Follicular Lymphoma (FL)
The ongoing Phase 3 OLYMPIA-1 confirmatory trial consists of a non-randomized safety run-in (Part 1) followed by a randomized efficacy portion (Part 2) evaluating odronextamab monotherapy versus rituximab plus standard-of-care chemotherapies.
In Part 1 (N=13), odronextamab led to complete responses (CR) in all 12 patients evaluable for efficacy at week 12. Historical clinical trial data indicate that the standard-of-care regimen R-Chemo was associated with an objective response rate (ORR) of
“The OLYMPIA-1 Phase 3 trial is designed to explore a novel, chemotherapy-free, fixed duration treatment that is being studied in the outpatient setting in patients with previously untreated follicular lymphoma,” said Elizabeth Brém, Associate Clinical Professor, Division of Hematology/Oncology at UC Irvine. “These compelling, initial data show the paradigm-changing potential of odronextamab in previously untreated patients and reinforce the remarkable complete response rates odronextamab demonstrated in late-line follicular lymphoma. We look forward to seeing the results of the Part 2 portion, which offers the first head-to-head evaluation of odronextamab monotherapy compared to standard-of-care chemo-immunotherapies.”
Durable Responses Shown in Diffuse Large B-Cell Lymphoma (DLBCL) that has Progressed After CAR-T Therapy
The primary analysis from an expansion cohort of the ELM-1 trial, which evaluated patients with DLBCL who progressed after CAR-T therapy, were presented in an oral session. Among 60 patients – with a median duration of treatment of 12 weeks (range <1 to 154 weeks) and a median duration of follow-up of 16 months – results assessed by independent central review showed:
48% ORR, with32% achieving a CR. These responses were observed across patients with high-risk features, including those that were refractory to their last therapy, double refractory, or refractory prior to CAR-T.- Among all patients, there was a 15-month median duration of response (DoR) (
95% confidence interval [CI]: 3 months to not estimable [NE]), 5-month median progression-free survival (PFS) (95% CI: 3 to 5 months), and a 10-month median overall survival (OS) (95% CI: 5 to 16 months). - Among CR patients, medians were not reached in terms of PFS (
95% CI: 9 months to NE) and OS (95% CI: 15 months to NE).
All patients experienced TEAEs, including
“Studies show that half of patients receiving CAR-T therapies relapse within six months, and up to
Compelling Efficacy Highlighted in Marginal Zone Lymphoma (MZL) in Heavily Pretreated Patients
Another oral presentation featured data from a cohort of heavily pretreated patients with relapsed/refractory (R/R) MZL, a setting with no approved treatment options. In the potentially pivotal ELM-2 trial, 42 patients were enrolled, of which 35 patients were evaluable for efficacy. At a median duration of follow-up of 11 months, results showed:
77% ORR, with all responders achieving a CR, per investigator assessment.- Medians were not reached in terms of DoR (
95% CI: 12 months to NE), duration of CR (95% CI: 12 months to NE), PFS (95% CI: 15 months to NE) and OS (95% CI: NE to NE).
Among 42 patients evaluated for safety, the most common TEAEs (≥
Odronextamab is approved in the European Union as Ordspono™ to treat R/R FL or DLBCL after two or more lines of systemic therapy but its safety and efficacy have not been fully evaluated by any other regulatory authority. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu. The U.S. regulatory resubmission for odronextamab in R/R FL after two or more lines of systemic therapy is expected to be submitted in the first half of 2025. The potential use of odronextamab in R/R MZL is investigational and has not been approved by any regulatory authority.
About B-Cell Non-Hodgkin Lymphomas (B-NHL)
B-NHL is the most common lymphoma in the United States and has several different subtypes including FL, DLBCL and MZL. FL and MZL are slow-growing subtypes, and both are incurable. It is estimated that approximately 120,000 FL cases are diagnosed annually worldwide, while MZL is estimated to be 5 to
About the Odronextamab Clinical Trial Program
Odronextamab is a CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. It is being investigated in a broad clinical program spanning several trials.
ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy, including a cohort of patients who had progressed after CAR-T therapy.
ELM-2 is an ongoing, open-label, multicenter Phase 2 trial investigating odronextamab across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, MZL and other subtypes of B-NHL. The primary endpoint is ORR according to the Lugano Classification as assessed by IRC, and secondary endpoints include CR, PFS, OS and DoR.
OLYMPIA is a broad Phase 3 clinical trial program investigating odronextamab in earlier lines of therapy and other B-NHLs and includes:
- OLYMPIA-1 evaluating odronextamab against rituximab plus standard-of-care chemotherapies in FL.
- OLYMPIA-2 evaluating odronextamab plus chemotherapy against rituximab plus standard-of-care chemotherapies in FL.
- OLYMPIA-3 evaluating odronextamab plus chemotherapy against rituximab plus standard-of-care chemotherapies in previously untreated DLBCL.
- OLYMPIA-4 evaluating odronextamab compared to an investigator’s choice of standard-of-care regimens in previously treated aggressive B-NHL.
- OLYMPIA-5 evaluating odronextamab plus lenalidomide against rituximab plus lenalidomide in FL and MZL.
Regeneron is also investigating additional odronextamab combination therapies in R/R aggressive B-NHL. These include the ATHENA-1 trial evaluating odronextamab in combination with a costimulatory CD22xCD28 bispecific antibody (REGN5837) and the CLIO-1 trial evaluating odronextamab in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab).
These potential uses described in the OLYMPIA, ATHENA-1 and CLIO-1 trials are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. For more information, visit the Regeneron clinical trials website or contact via clinicaltrials@regeneron.com or +1 844-734-6643.
About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.
Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.
Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
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| Contacts: | |
| Media Relations Tammy Allen Tel: +1 914-306-2698 tammy.allen@regeneron.com | Investor Relations Mark Hudson Tel: +1 914-847-3482 mark.hudson@regeneron.com |
1 Morschhauser F, Fowler NH, Feugier P, et al. Rituximab plus lenalidomide in advanced untreated follicular lymphoma. N Engl J Med. 379, 934-947 (2018).
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