Regeneron’s Ordspono Receives EU Approval for Lymphoma Treatment
Ordspono™ (odronextamab) Gains Approval in the European Union
Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, particularly in the post-CAR-T setting.
Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the outpatient setting, giving hope for complete remission.
Regulatory Approval Milestone for Regeneron Pharmaceuticals
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently announced that the European Commission has approved Ordspono™ (odronextamab) for treating adult patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after two or more systemic therapy lines. This marks the first regulatory approval of Ordspono globally for these patients. Ordspono functions as a bispecific antibody by linking lymphoma cells to killer T cells.
Stefano Luminari, M.D., a prominent figure in oncology, stated, "The EC approval of Ordspono is a significant advancement for EU patients and their physicians as a new treatment option for both indolent and aggressive lymphomas. In clinical trials, Ordspono demonstrated remarkable complete response rates in follicular lymphoma and compelling efficacy results in diffuse large B-cell lymphoma, including in the post-CAR-T setting. This will provide community physicians with an off-the-shelf option that can be easily administered outpatient, offering the chance for complete remission."
Clinical Trials Supporting Ordspono's Approval
The approval is supported by results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which presented robust, durable response rates in adults with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma:
- For relapsed/refractory follicular lymphoma, results from ELM-2 (N=128) showed an objective response rate (ORR) of 80%, with 73% of patients achieving complete response (CR). Among complete responders, the median duration of response (DoR) was noted at 25 months.
- In relapsed/refractory diffuse large B-cell lymphoma:
- Results from ELM-2 (N=127) indicated a 52% ORR in CAR-T therapy naïve patients, with a 31% complete response rate.
- Results from ELM-1 (N=60) in patients who progressed after CAR-T therapy demonstrated a 48% ORR and a 32% complete response rate, with a median DoR of 15 months.
The research revealed that the most frequently reported side effects were cytokine release syndrome (CRS; 54%), neutropenia (41%), and pyrexia (39%). Serious side effects included CRS (14%) and pneumonia (9%). With Ordspono, there exists a risk of severe infections and serious CRS.
Regeneron's Future Directions in Oncology
George D. Yancopoulos, M.D., Ph.D., expressed excitement about Ordspono's approval from the bispecific antibody platform, aiming to enhance their portfolio of impactful oncology medicines. He highlighted the OLYMPIA program, which includes multiple Phase 3 trials to investigate Ordspono both as monotherapy and in combinations for various therapy lines.
Furthermore, Regeneron is advancing a wider pipeline of CD3 and other bispecific therapies aimed at addressing both hematologic cancers, such as myeloma, as well as solid tumors.
Understanding Follicular Lymphoma and Diffuse Large B-cell Lymphoma
Follicular lymphoma and diffuse large B-cell lymphoma are regarded as the two most prevalent subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While follicular lymphoma generally manifests as a slow-growing subtype, it remains an incurable disease and most patients will relapse after their initial treatment. Diffuse large B-cell lymphoma, noted for its aggressive nature, afflicts up to 50% of high-risk patients who may experience disease progression following first-line treatment. Globally, about 120,000 cases of follicular lymphoma and 163,000 cases of diffuse large B-cell lymphoma are diagnosed each year.
Regeneron is conducting an extensive Phase 3 development initiative known as OLYMPIA, which is evaluating odronextamab in earlier therapy lines alongside other B-NHLs, thereby addressing significant unmet medical needs.
About Regeneron Pharmaceuticals
Regeneron (NASDAQ: REGN) develops groundbreaking medicines for serious diseases, driven by over three decades of biological expertise. Its research diverts focus towards innovative treatments for diverse cancers, autoimmune disorders, and rare ailments, utilizing proprietary technologies such as VelociSuite®. Regeneron is committed to pushing scientific boundaries to facilitate drug development and enhance patient outcomes.
Frequently Asked Questions
What is Ordspono and its significance?
Ordspono (odronextamab) is a bispecific antibody approved for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, marking a significant advancement in treatment options.
What were the key findings from clinical trials?
Clinical trials revealed an 80% objective response rate in follicular lymphoma and a 52% response rate in diffuse large B-cell lymphoma, showcasing its effectiveness.
Who is Regeneron Pharmaceuticals?
Regeneron is a leading biotechnology company known for developing innovative treatments across various serious conditions, including cancers and genetic diseases.
What are the common side effects associated with Ordspono?
Common side effects include cytokine release syndrome, neutropenia, and pyrexia. Serious side effects can vary, necessitating close medical oversight.
What does the future hold for Ordspono?
Regeneron is advancing ongoing clinical trials to assess Ordspono's effectiveness as monotherapy and in combination treatments with other therapies in earlier therapy lines.
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