The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind.
Regeneron will no longer seek accelerated approval for the bispecific antibody odronextamab in relapsed or refractory diffuse large B cell lymphoma, the pharma told Endpoints News on Wednesday.
Regeneron also revealed on Wednesday that the FDA has granted priority review to its biologics license application for the drug in relapsed or refractory follicular lymphoma. The pharma expects a decision by July 30, 2025.
Odronextamab is an investigational bispecific T-cell engager that works by binding to both the CD20 and CD3 surface proteins, acting as a bridge between cells that express these epitopes. Through this mechanism, odronextamab can facilitate the destruction of CD20-bearing cells through T-cell mediated toxicity.
Regeneron is testing odronextamab in various indications, including B-cell non-Hodgkin lymphoma, follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL). In a corporate presentation earlier this month, Regeneron pointed to the “potentially best-in-class” profile of odronextamab in FL, touting the potential of the T-cell engager to “address early-stage lymphoma patients with or without chemotherapy.”
Still, odronextamab hit a regulatory road bump in March 2024, when the FDA declined to grant accelerated approval for the drug in FL and DLBCL. At the time, Regeneron insisted that the “only approvability issue” with odronextamab was with the enrollment status of its confirmatory studies. The FDA, according to the pharma, did not flag problems with odronextamab’s safety or efficacy.
To support its application, the pharma filed data from the pivotal Phase II ELM-2 study, which showed an 80% objective response rate and a 73% complete response rate after odronextamab treatment.
Now, however, Regeneron appears to have adjusted its plans for odronextamab and is going for the FDA’s accelerated pathway only in FL. “Due to competitor developments, we no longer believe odronextamab in R/R DLBCL has an accelerated approval path and therefore, we plan to seek full approval pending data from ongoing Phase III studies,” a spokesperson told Endpoints.
It is not clear what “competitor developments” Regeneron is referring to, but in December 2024, Roche announced that the FDA had accepted its supplemental application to expand the label of the bispecific T-cell engager Columvi when used with gemcitabine and oxaliplatin. The combo can now be used in relapsed or refractory DLBCL patients who had undergone at least one prior line of therapy and who are ineligible for stem cell treatment.
That same month, Genmab posted strong long-term data for the T-cell engager epcoritamab, touting a 100% objective response rate—and an 87% complete response rate—in high-risk, previously untreated DLBCL patients. Responses were durable over a median follow-up of 27.4 months, while safety remained encouraging over this time, Genmab said.
