AbbVie, Genmab Secure FDA Label Expansion for Epkinly in Follicular Lymphoma

 AbbVie and Genmab’s bispecific antibody Epkinly (epcoritamab) can now be used to treat patients with relapsed or refractory follicular lymphoma, based on an FDA approval on Wednesday.

Epkinly is now the “first and only” T-cell-engaging bispecific antibody for the subcutaneous treatment of relapsed or refractory follicular lymphoma, according to the companies. The label expansion was approved under the FDA’s accelerated pathway, and its continued approval will depend on the validation of its clinical benefit in a confirmatory Phase III trial.

Mariana Cota Stirner, therapeutic area head for hematology at AbbVie, in a statement said that with the label expansion Epkinly now “offers a new treatment option for relapsed or refractory follicular lymphoma, particularly following failure of other therapies.”

Given its deep and durable response rates and convenient dosing, Epkinly “has the potential to be a core therapy in the treatment of multiple B-cell malignancies,” Stirner said.

Epkinly is an IgG1-bispecific antibody that targets the CD3 protein—found on T cells—and the CD20 antigen, which is typically expressed by B cells. This dual-targeting mechanism of action enables Epkinly to bring the cytotoxic T cells close to the malignant B cells and mount an anti-cancer response.

The bispecific antibody was first developed by Genmab using its proprietary DuoBody platform. In June 2020, AbbVie paid Genmab $750 million upfront and pledged up to $3.15 billion in milestones to jointly develop and commercialize the therapy. The partners won their first FDA approval in May 2023, allowing the use of Epkinly in relapsed or refractory diffuse large B-cell lymphoma.

Wednesday’s label expansion was backed by data from the Phase I/II EPCORE NHL-1 trial, which included 127 adult follicular lymphoma patients who had undergone a median of three prior lines of therapy. The majority of the patients also had double refractory disease.

Results from the trial showed that Epkinly achieved an objective response rate of 82%, including a 60% complete response rate and a 22% partial response rate. After a median follow-up of 14.8 months, more than half of responders remained responsive to Epkinly. EPCORE NHL-1 did not reach the median duration of response.

For AbbVie, Epkinly’s label expansion could help soothe the FDA’s rejection of its Parkinson’s disease therapy ABBV-95 earlier this week, citing issues with a third-party manufacturer. At the same time, the regulator found no issues with the candidate’s safety or efficacy, nor did it identify problems with the administration device.

Meanwhile, Wednesday’s approval continued Genmab’s regulatory winning streak which  includes an April 2024 full FDA approval for its Pfizer-partnered antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) in recurrent or metastatic cervical cancer.

https://www.biospace.com/article/abbvie-genmab-secure-fda-label-expansion-for-epkinly-in-follicular-lymphoma-/