Odronextamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma
Regeneron Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for odronextamab to treat relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). The recommendation is based on data from Phase 1 and Phase 2 trials showing robust and durable response rates. The European Commission is expected to make a final decision in the coming months. FL and DLBCL are common subtypes of B-cell non-Hodgkin lymphoma, with significant relapse rates after initial treatments. In Europe, approximately 15,000 FL and 31,000 DLBCL cases are diagnosed annually. The most common serious adverse reactions reported were cytokine release syndrome, pneumonia, COVID-19, and pyrexia. Odronextamab has not yet been approved by any regulatory authority and is still under clinical development.
- CHMP's positive opinion for conditional marketing authorization of odronextamab.
- Robust and durable response rates shown in Phase 1 and Phase 2 trials.
- Odronextamab granted Orphan Designation for both FL and DLBCL by the EMA.
- Common serious adverse reactions include cytokine release syndrome, pneumonia, COVID-19, and pyrexia.
- Odronextamab has not been approved by any regulatory authority yet.
Insights
The positive opinion from CHMP on odronextamab for relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) is a significant milestone in oncology. This recommendation aligns with the unmet needs within the patient population, particularly for those who have exhausted other treatment lines. The robust and durable response rates shown in Phase 1 and Phase 2 trials suggest that odronextamab could provide a much-needed option for these patients.
Follicular lymphoma (FL) is typically slow-growing but remains incurable, with most patients experiencing relapse. On the other hand, diffuse large B-cell lymphoma (DLBCL) is aggressive and up to
From a clinical perspective, the most common serious adverse reactions, including cytokine release syndrome and infections, are within expected ranges for treatments targeting immune cells. These safety concerns are notable but manageable within a clinical setting, making the therapy a promising candidate under controlled conditions. The Orphan Designation by the EMA underscores the rarity and critical need for new treatments in these specific lymphoma subtypes.
Regeneron's announcement has potential implications for the company's stock performance. The recommendation for conditional marketing authorization could mean a significant revenue stream if approval is granted by the European Commission. Investors should pay attention to the expected final decision in the coming months, which could act as a positive catalyst for the stock.
It's also worth noting that odronextamab's potential market is substantial. With estimated annual diagnoses of 15,000 FL cases and 31,000 DLBCL cases in Europe alone, the commercial opportunity is evident. Furthermore, Regeneron's strategic move to explore odronextamab as both a monotherapy and in combination treatments across different lines of therapy speaks to their long-term vision for this drug.
While the positive CHMP opinion is encouraging, investors should remain cautious of the typical pharmaceutical risks, such as unforeseen regulatory hurdles or adverse safety findings in ongoing trials. Diversifying investments and keeping an eye on further trial outcomes and regulatory updates will be crucial.
This recommendation could potentially alter the competitive landscape for lymphoma treatments in Europe. The current market for relapsed/refractory FL and DLBCL primarily comprises chemotherapy, targeted therapies and emerging immunotherapies. Odronextamab's entry, contingent upon final approval, would introduce a new competitor that has demonstrated promising efficacy and safety in clinical trials.
Regeneron's proactive approach in conducting extensive clinical programs, such as the Phase 3 OLYMPIA development program, is notable. This program's scale and breadth suggest a robust pipeline strategy, aiming to establish odronextamab as a cornerstone treatment within the lymphoma therapeutic area.
For retail investors, understanding the competitive dynamics and the potential uptake of new treatments is critical. If odronextamab secures market approval, it may capture significant market share, especially if positioned effectively against existing therapies. However, the success will also depend on post-approval real-world data and market penetration efforts by Regeneron.
Recommendation based on data from the Phase 1 and pivotal Phase 2 trials demonstrating robust and durable response rates in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
TARRYTOWN, N.Y., June 28, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The European Commission is expected to announce a final decision in the coming months.
FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While FL is a slow-growing subtype, it is an incurable disease, and most patients will relapse after initial treatment. DLBCL is an aggressive subtype, with up to
The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. In a pooled safety population, the most common serious adverse reactions were cytokine release syndrome, pneumonia, COVID-19 and pyrexia.
The EMA previously granted odronextamab Orphan Designation for both FL and DLBCL. Odronextamab is currently under clinical development and has not been approved by any regulatory authority.
Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs, as well as early-stage trials with chemotherapy-free combinations.
About the Odronextamab Clinical Trial Program
Odronextamab is an investigational 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.
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, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint is objective response rate according to the Lugano Classification as assessed by independent review committee, and secondary endpoints include complete response, progression-free survival, overall survival and duration of response.
In addition to the Phase 3 OLYMPIA development program, Regeneron is investigating odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and Regeneron’s PD-1 inhibitor cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies, respectively. For more information, visit the Regeneron clinical trials website, or contact 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 combination with each other 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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FAQ
What is the CHMP's recommendation regarding odronextamab?
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What are the serious adverse reactions associated with odronextamab?
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