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FDA Approves Genmab’s Epkinly to Treat Adults with Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy


Approval of Epkinly was based on results from the Phase I/II EPCORE trial in patients with relapsed or refractory follicular lymphoma who have already completed two or more lines of systemic therapy.

Follicular lymphoma (FL) cells in blood flow - closeup view 3d illustration. Image Credit: Adobe Stock Images/LASZLO

Image Credit: Adobe Stock Images/LASZLO

The FDA has approved Genmab A/S and AbbVie's Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. According to the company, the approval marks the first time that a subcutaneous T-cell engaging bispecific antibody has been approved in the United States for this indication. The approval of Epkinly was based on encouraging results from the Phase I/II EPCORE clinical trial, which showed an overall response rate (ORR) of 82% in patients administered Epkinly.1

“Patients with relapsed or refractory follicular lymphoma face significant treatment challenges, especially in third-line settings where there is currently no clear standard of care treatment,” said Jeff Sharman, MD, disease chair, hematology research, Sarah Cannon Research Institute at Willamette Valley Cancer Institute, Eugene, Oregon, in a press release. “This approval and the durable responses observed in the follicular lymphoma cohort of the EPCORE NHL-1 clinical trial, which reflected a real-world patient population, including patients with difficult-to-treat follicular lymphoma, demonstrate the potential of Epkinly for patients who face limited therapeutic options post-relapse.”

EPCORE NHL-1 is an open-label, multi-center, safety and preliminary efficacy trial that consisted of dose escalation, expansion, and optimization portions, and it included 127 patients. Additionally, the trial aimed to evaluate subcutaneous Epkinly in patients with R/R B-cell non-Hodgkin’s lymphoma, including FL. In the expansion part of the study, the primary endpoint was ORR assessed by an Independent Review Committee, with secondary endpoints including duration of response (DoR), complete response rate (CRR), duration of CRR, progression-free survival, and time to response as determined by the Lugano criteria. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of Epkinly through seven days after the second dose.

In addition to the ORR findings, investigators observed a CRR of 60%, which included 67% of patients achieving minimal residual disease negativity. After a median follow-up of 14.8 months, the DoR was not reached. Overall, more than half of the patients responded to the treatment in some form.

Treatment-emergent adverse events (AEs) that were most common in the FL cohort were injection site reaction, cytokine release syndrome (CRS), COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, fever, cough, and headache. Those who were treated with Epinkly as part of the recommended three-step dosage schedule experienced low grade CRS.

Genmab warns that use of Epinkly can cause a number of serious AEs, including CRS and neurologic problems that could eventually lead to death. Additionally, it can cause infections and low blood cell counts.1

“With this approval, patients whose follicular lymphoma has relapsed or is refractory to at least two or more lines of systemic therapy, now have the option to be treated with Epkinly, which has demonstrated durable responses without mandatory hospitalization using a three step-up dosage regimen in this patient population in clinical trials,” said Jan van de Winkel, PhD, CEO, Genmab, in the press release. “In just over a year, Epkinly has received a second indication in the US, making it the first and only bispecific antibody approved to treat patients with diffuse large B-cell lymphoma and follicular lymphoma after two or more lines of systemic therapy. The approved indications, along with the ongoing clinical development program, underscore the potential of [Epkinly] to become a core therapy across B-cell malignancies.”


1. EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL). Genmab. June 27, 2024. Accessed June 27, 2024. https://ir.genmab.com/news-releases/news-release-details/epkinlyr-epcoritamab-bysp-approved-us-fda-patients-relapsed-or

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