sBLA for Epcoritamab in R/R Follicular Lymphoma Earns FDA Priority Review

The regulatory agency has set a Prescription Drug User Fee Act date of June 28, 2024, for its decision on approving epcoritamab in relapsed/refractory follicular lymphoma.

The FDA has granted priority review to a supplemental biologics license application (sBLA) for epcoritamab-bysp (Epkinly) as a treatment for adult patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy, according to a press release from Genmab and AbbVie.¹

The regulatory agency has set a Prescription Drug User Fee Act date of June 28, 2024, for its decision on approving epcoritamab in the aforementioned indication.

“While treatment for patients with relapsed and refractory follicular lymphoma has progressed, there remains an urgent need for new treatment options, particularly for patients who are considered difficult to treat due to relapse following standard therapies and other poor prognostic factors,” Jan van de Winkel, PhD, chief executive officer at Genmab, said in the press release.¹ “The acceptance of the epcoritamab application for priority review marks an important milestone toward potentially providing a new treatment option to patients affected by [relapsed/refractory] follicular lymphoma.”

Supporting data for the sBLA came from the phase 1/2 EPCORE NHL-1 trial (NCT03625037). Investigators previously presented findings from the follicular lymphoma cohort of the trial at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.

With a median follow-up of 17.4 months among 128 evaluable patients in the follicular lymphoma cohort, epcoritamab yielded an overall response rate (ORR) of 82%, which included complete responses (CRs) in 63%.² The median time to response and CR, respectively, was 1.4 months and 1.5 months. Additionally, ORR and CR outcomes in prespecified high-risk subgroups, including those who were double refractory to prior treatments, were comparable with those observed in the overall population.

The median duration of response (DOR) and duration of CR was not reached with epcoritamab. Ongoing CRs were reported in 85% of patients at 12 months and in 74% at 18 months.

Any-grade cytokine release syndrome affected 67% of patients, and there were no reports of immune effector cell-associated neurotoxicity syndrome. Investigators observed no new safety signals associated with epcoritamab in the EPCORE NHL-1 trial.

“Despite treatment advances for patients with follicular lymphoma whose disease has unfortunately progressed, treating relapsed or refractory follicular lymphoma remains highly challenging, particularly as a third-line treatment,” Catherine Thieblemont, MD, PhD, head of the hemato-oncology department at Paris University of Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris, said in a press release on these findings.² “The patients in this trial represent a historically difficult-to-treat patient population. The data presented today are especially notable because they demonstrated high overall [response] and [CR] rates for this investigational therapy and a preview for its potential as a treatment option.”

Investigators of the open-label, multi-center EPCORE NHL-1 trial assessed subcutaneous epcoritamab as a treatment for patients with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkin lymphoma, which included those with follicular lymphoma.

The primary end point of the trial’s dose expansion portion was ORR as assessed by an independent review committee. Secondary end points included DOR, CR rate, duration of CR, progression-free survival, and time to response based on Lugano criteria.

The FDA previously granted breakthrough designation to epcoritamab for adult patients with relapsed/refractory follicular lymphoma following 2 prior lines of treatment in November 2023.³ The regulatory agency based its breakthrough designation on data from the EPCORE NHL-1 trial. The European Medicines Agency also validated a type II application for epcoritamab in the same indication.

References

1. U.S. FDA accepts for priority review the supplemental biologics license application for epcoritamab (EPKINLY®) for difficult-to-treat relapsed or refractory follicular lymphoma. News release. Genmab, Inc. and AbbVie. February 27, 2024. Accessed February 27, 2024. http://tinyurl.com/ymbche6k
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 and Genmab A/S. December 9, 2023. Accessed February 27, 2024. http://tinyurl.com/4ujufutt
3. AbbVie announces U.S. 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 November 28, 2023. https://shorturl.at/bxBY3