Genmab and AbbVie’s subcutaneous bispecific antibody Epkinly (epcoritamab) has met its dual primary endpoints as a second-line combination therapy in relapsed or refractory (r/r) follicular lymphoma (FL).
When used in combination with rituximab and lenalidomide (R2), Epkinly treatment led to an overall response rate (ORR) of 95.7% and a progression-free survival (PFS) of 79%, meeting both its dual primary endpoints of the Phase III EPCORE study (NCT05409066).
The safety profile of the combination therapy also remained consistent with that of the individual therapies, with no new signals observed in the trial.
Genmab CEO Dr Jan van de Winkel said: “While therapeutic options exist for patients with r/r FL, response rates tend to decline and durability diminishes with each subsequent line of treatment, which can increase the risk of the disease transforming into aggressive large-cell lymphoma.”
AbbVie and Genmab partnered on the development of Epkinly in 2020. The therapy is a bispecific antibody that targets CD3 and CD20, redirecting and activating T-cells to CD20-expressing cancer B-cells.
Second-line approval could be key
The therapy was granted accelerated approval by the US Food and Drug Administration (FDA) in June 2024 for its use in third-line treatment in FL.
Genmab said that Epkinly was accepted for priority review through a supplemental biologics license application (sBLA) by the FDA for use in combination with R2 as a second-line therapy in FL, with a decision expected under the Prescription Drug User Fee Act (PDUFA) by 30 November 2025.
Genmab said that if it receives the FDA approval, Epkinly will be the first bispecific antibody combination regimen available in the US as a second-line treatment option for patients with r/r FL. The therapy is also approved for use in r/r diffuse large B-cell lymphoma (DLBCL).
The first bispecific antibody approved in third-line FL was Roche/Genentech’s Lunsumio (mosunetuzumab-axgb) on 22 December 2022. While it holds a first-to-market advantage, both its intravenous formulation and later-stage use could put it at a disadvantage to Epkinly.
Roche is trying to close in on the administration, however, running several Phase III trials of a subcutaneous Lunsumio. A Phase II trial of the drug showed it matched the intravenous therapy in third-line FL, and the injectable version has also shown benefit in a Phase III trial in large B-cell lymphoma (LBCL).
According to GlobalData, Genmab and AbbVie’s drug is likely to do better on the market, with a 2031 forecast of $2.32bn compared to $999m for Lunsumio.
GlobalData is the parent company of Pharmaceutical Technology.
Roche also has another bispecific antibody on the market, Columvi (glofitamab), which is approved for use in third-line DLBCL. According to GlobalData analysis, Columvi sales are set to reach $2.03bn in 2031.
