Mosunetuzumab

The Phase III trial sets Genmab and AbbVie up for approval of the Epkinly in the second line FL setting. Image credit: Nemes Laszlo / Shutterstock.com. 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 . GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence 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. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Genmab and AbbVie’s cancer drug Epkinly succeeded in a Phase 3 trial for second-line follicular lymphoma patients, meaning the T cell engager could soon be used to treat patients earlier. In a study of 549 patients, adding Epkinly to rituximab and Revlimid improved both overall response rate and progression-free survival compared to the combination of the latter two drugs alone — meeting both primary endpoints in the EPCORE FL-1 study, Genmab said. At a first interim analysis, the overall response rate was 95.7%, and the drug cut the risk of disease progression or death by 79%. The FDA is expected to decide whether to approve the Epkinly combination in second-line follicular lymphoma patients by Nov. 30. Currently, Epkinly is approved for third-line or later follicular lymphoma, as well as certain B cell lymphoma patients. The drug is sold as Tepkinly in the EU. Genmab said it has submitted the data to the American Society of Hematology annual meeting and expects to share the full results later this year. The results come ahead of an upcoming Phase 3 readout expected this year from Roche on its competing T cell engager, Lunsumio, in a similar setting. Jefferies analyst Benjamin Jackson said in a note to investors Thursday that Genmab’s “robust” readout “set a high bar” for Roche. Genmab said that the safety outcomes in the trial were “consistent with the known safety profiles” of Epkinly and the combination of rituximab and Revlimid. Epkinly is a bispecific antibody designed to target CD20 on lymphoma cells and CD3 on T cells, with the hopes of getting the T cells to destroy the malignant cells. AbbVie partnered with Genmab on the compound in 2020, and the duo is jointly commercializing the drug in the US and Japan, while AbbVie is in charge of commercializing it outside of these two countries. Earlier this year, AbbVie sued Genmab, accusing it of stealing trade secrets to make a potential rival to its ovarian cancer drug Elahere. Genmab declined to comment on that litigation.