FDA Grants Priority Review to BLA for Odronextamab in FL and DLBCL

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Priority review to the biologics license application for odronextamab has been granted by the FDA for adult patients with follicular lymphoma and diffuse large B-cell lymphoma.

  • Findings from 2 studies support this biologics license application (BLA) for odronextamab (REGN 1979) for patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL).

  • If granted approval by the FDA, odronextamab would be the first and only bispecific antibody approved in both FL and DLBCL.

  • Odronextamab previously received an orphan drug designation (ODD) and fast track designation (FTD) by the FDA for these patient populations.

The FDA has granted priority review to BLA for odronextamab, a prospective option for the treatment of adult patients with R/R FL or R/R DLBCL who have progressed after at least 2 prior systemic therapies.1

Findings supporting the BLA come from the phase 1 ELM-1 trial (NCT02290951) and the phase 2 ELM-2 trial (NCT03888105). In both studies, odronextamab demonstrated clinically meaningful efficacy, including complete responses. The agent also demonstrated durability of responses.

In the DLBCL cohort of the 2 studies, the overall response rate was 49% among heavily pre-treated patients who were naïve prior to CAR T, and 31% of patients achieved a complete response (CR). In the FL cohort, there was an 82% response rate in patients with grades I-IIIA disease, with 75% of the overall population achieving a CR.2


“Our overarching vision is not only to combine with standard of care in earlier lines of therapy, so moving into first-line follicular lymphoma, first-line diffuse large B-cell lymphoma and second-line, but also comparing monotherapy vs standard of care. We believe that the level of efficacy that we have observed is compelling enough, and we feel confident that we have a great opportunity to bring patients to have a chemo-free regimen in the future. Both combinations with standard of care and monotherapy will be explored in our phase 3 comprehensive program,” Andres Sirulnik, senior vice president, translational and clinical sciences, hematology, previously told Targeted OncologyTM, in an interview.

lymphoma cells : © Dr_Microbe - stock.adobe.com

lymphoma cells : © Dr_Microbe - stock.adobe.com

Odronextamab is a CD20 x CD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation, as well as cancer cell killing. Previously, the agent was granted an FTD and ODD by the FDA, as well as an ODD by the European Medicines Agency for FL and DLBCL.1


ELM-1 is an ongoing, open-label, multicenter, phase 1 trial looking to investigate the safety and tolerability of odronextamab in patients with CD20-positive B-cell malignancies. Patients enrolled must have been previously treated with CD20-directed antibody therapy. In the expansion cohort of the trial, patients with DLBCL who had progressed on chimeric antigen receptor (CAR) T-cell therapy are also being evaluated.

In ELM-2, an ongoing, open-label, multicenter, pivotal, phase 2 trial investigating odronextamab, 375 patients are enrolled across 5 independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma, and other subtypes of B-cell non-Hodgkin lymphoma (B-NHL). Investigators are assessing the primary end point of objective response rate according to the Lugano Classification, and secondary end points of CR, progression-free survival, overall survival, duration of response, disease control rate, safety, and quality of life, in the study.

In addition to these 2 studies, Regeneron is initiating a broad phase 3 development program which will assess treatment with odronextamab in earlier lines of therapy and other B-NHLs, representing one of the largest clinical programs in lymphoma.

Odronextamab remains under clinical development as its safety and efficacy have not yet been fully evaluated by any regulatory authority.



REFERENCE:
  1. Odronextamab BLA for treatment of relapsed/refractory follicular lymphoma (FL) and diffuse large b-cell lymphoma (DLBCL) accepted for FDA priority review. News release. Regeneron Pharmaceuticals, Inc. September 29, 2023. Accessed September 29, 2023. https://tinyurl.com/386ne2xe
  2. Walewski J, Min Kim T, Cho SG, et al. P1115: Odronextamab in patients with relapsed/refractory diffuse large B-cell lymphoma: results from a prespecified analysis of the pivotal phase 2 STUDY ELM-2. Hemasphere. 2023;7(Suppl ):e50570ac. Published 2023 Aug 8. doi:10.1097/01.HS9.0000971356.50570.ac
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