FDA Grants Priority Review for Second Epkinly Indication

The FDA has granted priority review review to the supplemental biologics license application (sBLA) for Epkinly (epcoritamab-bysp), a subcutaneously administered T-cell engaging bispecific antibody to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of therapy. A priority review shortens the agency’s review time to six months; the target date is in August 2024.

Follicular lymphoma is a slow-growing form of non-Hodgkin’s lymphoma that arises from B-lymphocytes. It accounts for 20% to 30% of all non-Hodgkin’s lymphoma cases.

Developed by AbbVie and Genmab, Epkinly was approved in May 2023 as a third-line therapy to treat patients with diffuse large B-cell lymphoma (DLBCL) treatment. Epkinly that targets CD3 on the surface of T cells and CD20 on the surface of B cells. Epkinly is a monthly therapy with a cost of $37,500 per month. Copay assistance is available through Genmab’s MyNavCare program. The current maximum benefit is $25,000 per year. In 2023, Epkinly generated $31 million in worldwide revenue for AbbVie. Under the agreement with AbbVie, Genmab receives royalties of between 22% and 26% on net sales outside the United States and Japan. Genmab and AbbVie evenly split product sales in other territories. Genmab’s financial statements for 2023 did not break out sales figures for Epkinly.

The sBLA is based on results from the phase 1/2 EPCORE NHL-1 clinical trial, which demonstrated high overall and complete responses in patients with relapsed or refractory follicular lymphoma after two or more lines of therapy. Patients treated with Epkinly experienced 82% overall response rate including 63% complete response rate at a median follow up of 17.4 months. An estimated 85% and 74% of patients who experienced a complete response remained responsive to treatment at 12 and 18 months, respectively.

The most common treatment-emergent adverse event was cytokine release syndrome with 67% occurrence. Additional treatment-emergent adverse events include injection-site reaction, COVID-19, fatigue, neutropenia, diarrhea and pyrexia. Treatment-emergent adverse event leading to treatment discontinuation occurred in 19% of patients, and death related to treatment occurred in 13 patients.

Data from the follicular lymphoma cohorts of the trial were presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2023.

Catherine Thieblemont, M.D., Ph.D.

“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, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris, said in a press release. “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 and complete response rates for this investigational therapy and a preview for its potential as a treatment option.”