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Regeneron’s Promising Phase 3 Trial for Follicular Lymphoma: A Potential Game-Changer?

Regeneron’s Promising Phase 3 Trial for Follicular Lymphoma: A Potential Game-Changer?

Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.

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Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled ‘A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)’. The study aims to evaluate the safety, tolerability, and efficacy of odronextamab combined with chemotherapy compared to the standard treatment of rituximab with chemotherapy in patients with follicular lymphoma, a type of non-Hodgkin lymphoma.

The intervention being tested is odronextamab, an experimental bispecific antibody designed to target CD20 and CD3 proteins, administered alongside chemotherapy drugs such as cyclophosphamide, doxorubicin, vincristine, and prednisone. The goal is to determine the optimal dose and schedule for odronextamab in combination with chemotherapy.

This interventional study employs a randomized, parallel assignment model with no masking, focusing on treatment as its primary purpose. It consists of three parts, with Part 1A being non-randomized and Parts 1B and 2 being randomized and controlled, to compare the effectiveness of the new treatment regimen against the current standard of care.

The study began on October 18, 2023, with an estimated primary completion date in 2025. The last update was submitted on August 26, 2025, indicating ongoing recruitment and data collection efforts.

The outcome of this study could significantly impact Regeneron’s market position, potentially boosting its stock performance if the results demonstrate superior efficacy and safety of odronextamab. This could also influence investor sentiment positively, especially in comparison to competitors in the oncology sector.

The study is currently ongoing, with further details available on the ClinicalTrials portal.

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