FDA Grants Priority Review to Epcoritamab-bysp for Relapsed or Refractory Follicular Lymphoma


If approved, epcoritamab (DuoBody CD3xCD20; AbbVie, Genmab) would be the first and only subcutaneous bispecific antibody for treatment in this patient population.

The FDA has granted priority review to a supplemental biologics license application (sBLA) for epcoritamab-bysp (DuoBody CD3xCD20; AbbVie, Genmab), a T-cell engaging bispecific antibody that is subcutaneously administered for the treatment of relapsed or refractory follicular lymphoma (R/R FL) after 2 or more lines of therapy in adults. If approved, epcoritamab would be the first and only subcutaneous bispecific antibody for treatment in this patient population, according to a press release from AbbVie.1

Lymphoma Cancer Cell Hematology | Image Credit: catalin - stock.adobe.com

catalin - stock.adobe.com

"Despite new treatment options, [FL] remains incurable and difficult to treat. Unfortunately, relapse is common and additional lines of treatment are needed," Mariana Cota Stirner, MD, PhD, vice president and therapeutic area head for hematology at AbbVie. "Together with our partner Genmab, we are committed to further advancing epcoritamab as a core lymphoma therapy."1

About The ENCORE NHL-1 Trial

Trial Name: A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/​R DLBCL

ClinicalTrials.gov ID: NCT04628494

Sponsor: Genmab

Completion Date (Estimated): April 2028

The sBLA is based on results from the ENCORE NHL-1 (NCT04628494) phase 1/2 clinical trial, which showed high overall response rate (ORR) and complete responses (CR) in the patient population. The data were presented at the Annual Meeting and Exposition of the American Society of Hematology in December 2023, according to the press release.1

The trial was conducted in 3 parts: a phase 1 first-in-human dose escalation, a phase 2a expansion, and a phase 2a dose optimization. Investigators evaluated the drug in individuals with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkin lymphoma, including FL. The primary endpoint was ORR and secondary endpoints included duration of response, CR rate, duration of complete response, progression-free survival, and time to response. Other secondary endpoints included overall survival, time to next therapy, and rate of minimal residual disease negativity, according to a press release from AbbVie.2

The investigators included 128 adults in the study and found an ORR of 82% with a CR rate of 63% at the median follow-up of 17.4 months. The median time to response was 1.4 months and the median CR was 1.5 months. For those who were refractory to prior treatment, the ORR and CR rates were generally consistent with the overall study population. At the 12- and 18-month marks, approximately 85% and 74% of patients who experienced a CR remained responsive to treatment, respectively, according to the press release.2

In the study, there were no new safety signals identified and the most common treatment emergent adverse event (TEAE) was cytokine release syndrome. Additional TEAEs included injection-site reaction, COVID-19, fatigue, neutropenia, diarrhea, and pyrexia, according to the press release.2

Priority review is given to investigational therapies that have the potential for significant improvements in safety or efficacy of the treatment, diagnosis, or prevention of serious conditions compared to the standard of care.1 Previously, epcoritamab was granted breakthrough therapy designation for the same patient population in the United States as well as a validated Type II application by the European Medicines Agency for the same indication.That update was also supported by the same study results.3

  1. US Food and Drug Administration Grants Priority Review of Epcoritamab (Epkinly) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma (FL). News release. AbbVie. February 27, 2024. Accessed February 28, 2024. https://prnmedia.prnewswire.com/news-releases/us-food-and-drug-administration-fda-grants-priority-review-of-epcoritamab-epkinly-for-difficult-to-treat-relapsed-or-refractory-follicular-lymphoma-fl-302071777.html
  2. New Data for Bispecific Antibody Epcoritamab (DuoBody CD3xCD20) Shows Strong, Durable Treatment Response for Patients with Difficult-To-Treat Relapsed/Refractory (R/R) Follicular Lymphoma (FL). News release. AbbVie. December 9, 2023. Accessed February 28, 2024. https://news.abbvie.com/2023-12-09-New-Data-for-Bispecific-Antibody-Epcoritamab-DuoBody-R-CD3xCD20-Shows-Strong,-Durable-Treatment-Response-for-Patients-with-Difficult-To-Treat-Relapsed-Refractory-R-R-Follicular-Lymphoma-FL
  3. AbbVie Announces US Food and Drug Administration (FDA) and European Medicines Agency (EMA) Updates for Epcoritamab (Epkinly/ Tepkinly) for the Treatment of Relapsed/Refractory Follicular Lymphoma. News release. AbbVie. November 27, 2023. Accessed February 28, 2024. https://news.abbvie.com/2023-11-27-AbbVie-Announces-U-S-Food-and-Drug-Administration-FDA-and-European-Medicines-Agency-EMA-Updates-for-Epcoritamab-EPKINLY-R-TEPKINLY-R-for-the-Treatment-of-Relapsed-Refractory-Follicular-Lymphoma
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