Ordspono™ (odronextamab) Receives EU Approval
The European Commission has granted approval for Ordspono, based on compelling data showing strong and lasting responses in patients with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, especially after CAR-T therapy.
As Regeneron’s first bispecific antibody to gain approval, Ordspono offers a convenient off-the-shelf treatment option that can be given in an outpatient setting, providing hope for patients seeking complete remission.
Regeneron Pharmaceuticals Celebrates Regulatory Approval
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the European Commission has approved Ordspono™ (odronextamab) for adult patients facing relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This marks Ordspono's first regulatory approval worldwide for these specific patient groups. The bispecific antibody works by connecting lymphoma cells with killer T cells.
Dr. Stefano Luminari, a leading oncologist, remarked, "The EC’s approval of Ordspono represents a major step forward for patients and their healthcare providers in the EU, offering a new treatment option for both indolent and aggressive lymphomas. In clinical trials, Ordspono showed impressive complete response rates in follicular lymphoma and significant efficacy in diffuse large B-cell lymphoma, particularly in the post-CAR-T context. This provides community physicians with a readily available treatment option that can be administered in an outpatient setting, enhancing the possibility of complete remission."
Clinical Trials That Back Ordspono's Approval
The approval is backed by findings from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated strong and durable response rates in adults with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma:
- In the ELM-2 trial (N=128) for relapsed/refractory follicular lymphoma, an objective response rate (ORR) of 80% was observed, with 73% of patients achieving a complete response (CR). The median duration of response (DoR) among those who completely responded was 25 months.
- For relapsed/refractory diffuse large B-cell lymphoma:
- In CAR-T therapy naïve patients, ELM-2 (N=127) showed a 52% ORR and a 31% complete response rate.
- In patients who progressed after CAR-T therapy, ELM-1 (N=60) indicated a 48% ORR and a 32% complete response rate, with a median DoR of 15 months.
The trials identified cytokine release syndrome (CRS; 54%), neutropenia (41%), and pyrexia (39%) as the most common side effects. Serious side effects included CRS (14%) and pneumonia (9%). Patients receiving Ordspono may also face risks of severe infections and serious CRS.
Regeneron's Vision for Oncology
Dr. George D. Yancopoulos, M.D., Ph.D., expressed enthusiasm for Ordspono's approval, which stems from their bispecific antibody platform, as they aim to expand their portfolio of impactful oncology treatments. He also highlighted the OLYMPIA program, which encompasses several Phase 3 trials to explore Ordspono both as a standalone treatment and in combination with other therapies across various treatment lines.
Additionally, Regeneron is developing a broader pipeline of CD3 and other bispecific therapies targeting hematologic cancers like myeloma, as well as solid tumors.
Overview of Follicular Lymphoma and Diffuse Large B-cell Lymphoma
Follicular lymphoma and diffuse large B-cell lymphoma are recognized as the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). Follicular lymphoma typically presents as a slow-growing subtype but remains incurable, with most patients experiencing a relapse after initial treatment. In contrast, diffuse large B-cell lymphoma is known for its aggressive nature, affecting up to 50% of high-risk patients who may see disease progression following first-line treatment. Annually, there are approximately 120,000 new cases of follicular lymphoma and 163,000 cases of diffuse large B-cell lymphoma diagnosed worldwide.
Regeneron is actively pursuing an extensive Phase 3 development program called OLYMPIA, which evaluates odronextamab in earlier treatment lines alongside other B-NHLs, addressing significant unmet medical needs.
About Regeneron Pharmaceuticals
Regeneron (NASDAQ: REGN) is dedicated to developing innovative medicines for serious diseases, leveraging over thirty years of biological expertise. Their research focuses on pioneering treatments for various cancers, autoimmune disorders, and rare diseases, utilizing proprietary technologies like VelociSuite®. Regeneron is committed to advancing scientific boundaries to facilitate drug development and improve patient outcomes.
Frequently Asked Questions
What is Ordspono and why is it important?
Ordspono (odronextamab) is a bispecific antibody that has been approved for the treatment of relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, representing a significant step forward in available treatment options.
What were the main results from the clinical trials?
Clinical trials showed an 80% objective response rate in patients with follicular lymphoma and a 52% response rate in those with diffuse large B-cell lymphoma, highlighting its efficacy.
Who is Regeneron Pharmaceuticals?
Regeneron is a prominent biotechnology firm recognized for its innovative treatments for a range of serious conditions, including cancers and genetic disorders.
What side effects are commonly associated with Ordspono?
Common side effects include cytokine release syndrome, neutropenia, and pyrexia. Serious side effects can occur, requiring careful medical supervision.
What does the future hold for Ordspono?
Regeneron is progressing with clinical trials to evaluate Ordspono's effectiveness both as a standalone treatment and in combination with other therapies in earlier treatment lines.
