Epkinly Combo Reduces Risk of Progression or Death in Follicular Lymphoma

Epkinly with Rituxan and Revlimid, compared to Rituxan and Revlimid alone, reduced risk of progression or death by 79%.

Among adult patients with relapsed or refractory follicular lymphoma, the treatment combination of subcutaneous Epkinly (epcoritamab) with Rituxan (rituximab) and Revlimid (lenalidomide), when compared to treatment with Rituxan and Revlimid alone, was found to elicit responses, reducing the risk of disease progression or death by 79%.

These findings from a pre-planned interim analysis from the phase 3 EPCORE FL-1 clinical trial, announced in a news release by Epkinly manufacturer Genmab A.S, are set to be submitted for presentation at the 67^thAnnual Meeting and Exposition of the American Society of Hematology, which will be held Dec. 6 to 9 in Orlando, Florida. Additionally, the findings will be used as the basis for global regulatory submissions, according to the news release.

Furthermore, the news release detailed that in late July the U.S. Food and Drug Administration accepted a supplemental biologics license application (sBLA) for priority review for the treatment combination of Epkinly, Rituxan and Revlimid after at least one prior systemic therapy, based on data from a first interim analysis that showed a 95.7% objective response rate and a 21% risk of disease progression or death.

The FDA, Genmab noted, has set a Prescription Drug User Fee Act target action date of Nov. 30, 2025 and, if approved, the treatment trio would be the first bispecific antibody combination regimen available in the United States as a second-line treatment option for patients with relapsed or refractory follicular lymphoma.

Epkinly, a type of treatment known as a bispecific T-cell engager, binds to a protein called CD20 found on T cells, a type of white blood cell and part of the immune system, as well as to a protein called CD20, which is found on B cells, another type of white blood cell, and some lymphoma cells, which may help the immune system kill cancer cells, as explained by the National Cancer Institute on its website.

The EPCORE FL-1 clinical trial, with 549 participating patients, is being conducted at 273 locations around the world, according to its listing on clinicaltrials.gov. It is expected to be completed in approximately December 2029, according to the listing.

In the trial, according to the news release, the safety profile of the treatment combination has been found to be consistent with the known safety profiles of each individual regimen, with no new safety signals having been observed, according to the news release.

In June 2024, the FDA granted an accelerated approval to single-agent Epkinly for patients with relapsed or refractory follicular lymphoma who were previously treated with two or more lines of systemic therapy, as CURE reported last year.

“The nature of follicular lymphoma lies in the underlying pathogenesis. Essentially, this is a disease that is generally indolent, so it's generally slow growing, waxing and waning, but currently with our available therapies, it's still considered incurable, and so especially for our patients who are diagnosed at a younger age, there is a need for better therapies, or more therapies that will essentially prolong, that will help get the disease under control and actually control the disease for a long time. Ideally, we want this condition, obviously, to be curable. We want to be able to cure this, but I think at the end of the day, we want to make sure that this does not harm our patients or cause complications with their daily life,” explained Dr. Christina Poh, a physician at the Fred Hutch Cancer Center and an assistant professor in the Division of Hematology and Oncology, University of Washington School of Medicine, in a previous interview with CURE.

“While therapeutic options exist for patients with relapsed or refractory follicular lymphoma, 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,” said Jan van de Winkel, Chief Executive Officer of Genmab, in the news release. “The results from this trial, and the decision from the FDA to accept the sBLA for priority review, demonstrate the potential of this [Epkinly] combination therapy to reshape the treatment landscape and reinforces our shared commitment with AbbVie to advance [Epkinly] as a potential core therapy across B-cell malignancies.”

Reference

1. Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL),” Genmab. News Release. Aug 7, 2025.

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