The Food and Drug Administration (FDA) granted a priority review for a Biologics License Application to odronextamab for the treatment of adults with relapsed or refractory follicular lymphoma or relapsed or refractory diffuse large B-cell lymphoma (DLBCL) — the most common types of B-cell non-Hodgkin lymphoma — who experienced disease progression on two or more prior therapies, according to a press release issued by Regeneron, the manufacturer of the drug.
The FDA grants priority reviews to drugs that show promise in treating serious conditions or illnesses. In doing so, the agency works with the developers of the drug to expedite the review and potential approval of the therapy, thereby getting it to patients who may benefit sooner. The agency has established a deadline of March 31, 2024 to decide on odronextamab’s approval.
Data from the ELM-1 and ELM-2 clinical trials, which were presented in December 2022 at the American Society of Hematology Annual Meeting, led to the FDA’s decision.
ELM-1 is an ongoing trial investigating the safety and tolerability of odronextamab in patients with CD20-positive B-cell malignancies who have previously been treated with a CD20 antibody. This includes an expanded group of patients with DLBCL who experienced disease progression after undergoing CAR-T cell therapy. According to the study’s listing on ClinicalTrials.gov, the study started in 2023 and is expected to be completed in 2027.
ELM02 is an ongoing phase 2 trial that is analyzing odronextamab in multiple subtypes of blood cancer: DLBCL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-cell non-Hodgkin lymphoma. The main goal of this trial is objective response rate, while secondary goals include complete response, progression-free survival (time from treatment until death or disease worsens), overall survival (time from treatment until death of any cause), duration of response, disease control rate, safety and quality of life. Per ClinicalTrials.gov, the trial launched in 2019 and is expected to be complete in 2028.
Notably, study data showed that in patients with grades 1 to 3a follicular lymphoma, there was an 82% response rate (percentage of patients whose disease shrinks or disappears from treatment), including 75% of patients who achieved a complete response, indicating that there were no visible signs of cancer after treatment.
In patients with DLBCL, there was a 49% response rate in patients who were heavily pretreated and had not been treated with a CAR-T cell therapy. Among this patient population, 31% experienced a complete response. For patients with DLBCL who received CAR-T cell therapy before undergoing treatment with odronextamab, the researchers reported a 48% response rate and 32% complete response rate.
Follicular lymphoma is a slow-growing subtype of B-cell lymphoma, with approximately 20% of patients expected to experience relapse within two years, while DLBCL tends to be more aggressive, according to Regeneron, with approximately 50% of high-risk patients experiencing disease progression after their first therapy.
Odronextamab is an investigational drug that works by bringing together immune T cells to cancer cells by attaching to the CD20 protein found on B-cell cancers and CD3, a protein found on the surface of T cells. In turn, the T cells can then attack the cancer.
Regeneron also mentioned that the company is initiating a phase 3 development program that will analyze odronextamab in earlier lines of therapy for patients with B-cell non-Hodgkin lymphomas.
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