FDA Grants Epcoritamab Breakthrough Drug Designation for FL

• The FDA has granted a breakthrough drug designation (BTD) to epcoritamab-bysp (Epkinly) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received 2 or more lines of systemic therapy.¹
• The European Medicines Agency has also approved a Type II variation application for epcoritamab for same indication.
• BTD can help to expedite the drug development and review pipeline for treatment options for serious or life-threatening diseases.

Lymphomas: © immimagery - stock.adobe.com

Epcoritamab, an investigational T-cell-engaging bispecific antibody, has received a BTD from the FDA in R/R FL. The BTD is supported by findings from the phase 1/2 EPCORE NHL-1 trial (NCT03625037).¹

“Despite recent treatment advances in relapsed or refractory follicular lymphoma, a need still exists for more treatment options,” said Jan van de Winkel, PhD, chief executive officer of Genmab, EPCORE NHL-1 study sponsor, in a press release. “We are encouraged by these recent decisions from the regulatory authorities, and we are hopeful that this may help accelerate the process of delivering epcoritamab to people living with this disease.”

About the EPCORE NHL-1 Study

The phase 1/2 is a global, multicenter, open-label safety and efficacy trial of epcoritamab in patients with a documented CD20-positive mature B-cell neoplasm.² The trial has an estimated enrollment of 786 patients with R/R disease following treatment with an anti-CD20 monoclonal antibody.

The primary end points for the dose-escalation portion are dose-limiting toxicities and incidence of adverse events. The primary end point for the dose-expansion portion is objective response rate (ORR). The primary end points for the dose-optimization portion are number of patients with cytokine release syndrome (CRS) and percentage of patients with grade 2 or higher CRS events. Secondary end points include ORR, partial response rate, complete response rate, time to response, duration of response, progression-free survival, and overall survival.

To be eligible to participate, patients cannot have primary central nervous system (CNS) lymphoma or CNS involvement, a known past or current malignancy other than inclusion diagnosis, clinically significant cardiovascular disease, a history of autoimmune disease or immunosuppression, or active hepatitis B, hepatitis C, or HIV infection. Patients must also have acceptable renal and liver functions and an ECOG performance status of 0-2 to be included in the study.

The study has an estimated completion date of April 2024. Updated findings from the EPCORE NHL-1 study will be presented at the 2023 American Society of Hematology annual meeting on December 9-12 in San Diego, California.¹

REFERENCES:

1. Genmab announces positive regulatory updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma. News release. Genmab. November 27, 2023. Accessed November 27, 2023. https://tinyurl.com/5mprp34d

2. First-in-human (FIH) trial in patients with relapsed, progressive or refractory B-cell lymphoma (EPCORE NHL-1). ClinicalTrials.gov. Updated August 8, 2023. Accessed November 27, 2023. https://www.clinicaltrials.gov/study/NCT03625037