The FDA has granted priority review to odronextamab for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
The FDA has granted priority review designation to the biologic license application (BLA) for odronextamab, according to the manufacturers, who are seeking its approval for both patients with relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) whose disease has progressed following at least 2 prior systemic therapies.1
The target action date has been set for March 31, 2024.
Data Behind the BLA
The manufacturers filed the BLA following the presentation of the phase 1 ELM-1 trial (NCT02290951) and the phase 2 ELM-1 trials (NCT03888105), which were presented at the 64th Annual American Society of Hematology Annual Meeting.2,3
Among pretreated patients with DLBCL who were naïve to CAR T (n = 130), 49% achieved a response and 31% achieved a complete response. Results were similar among those who had also been exposed to CAR T. Among these patients, the overall response rate (ORR) was 48% and the complete response rate was 32%. Among patients who were naïve to, or had prior exposure to CAR-T, the median duration of complete response was 18 months (95% CI, 10-not evaluable [NE]) and not reached (95% CI, 2 months-NE), respectively.
Among patients with follicular lymphoma (n = 121), the overall response rate was 82% and the complete response rate was 75%. This included patients with grade 1 through grade 3a disease, and the median duration of complete response was 20.5 months (95% CI, 17.0-NE). Moreover, the median progression-free survival was 20.5 months (95% CI, 15-NE) and the median overall survival was not reached (95% CI, NE-NE).
First Bispecific Antibody for These Indications
According to the press release, if approved, odronextamab would be the first bispecific antibody approved for both follicular lymphoma and diffuse large B-cell lymphoma, which are the 2 most common subtypes of B-cell non-Hodgkin lymphoma. The FDA has previously granted odronextamab an orphan drug designation and fast track designation for these patient populations.
Odronextamab is an investigational CD20xCD3 bispecific antibody. It is designed to bridge CD20 on cancer cells with CD3-expressing T cells, which, in turn, instigate local T-cell activation and cancer-cell killing.
While the agent is still under development, and its safety and efficacy have not been established, it is being evaluated in a phase 3 development program launched by Regeneron. The program will investigate odronextamab in early lines of therapy and in patients with other B-cell non-Hodgkin lymphomas.