AbbVie and Genmab’s subcutaneous Epkinly (epcoritamab) has proved to be viable as an outpatient treatment in a Phase II trial.
The Phase II EPCORE NHL-6 trial (NCT05451810) investigated the drug in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy.
The study demonstrated the feasibility of treating and monitoring patients in an outpatient setting following the first dose of Epkinly and showed that the incidence and severity of adverse events (AEs) associated with Epkinly were consistent with previous Epkinly studies in patients with r/r DLBCL.
In the trial, 88 patients received the first full dose monotherapy, with 81 of these patients being dosed in the outpatient setting and seven in the inpatient setting.
Of those treated and monitored as outpatients, 57 (70%) did not experience cytokine release syndrome (CRS) during the first full dose period.
Overall, CRS events occurred in 37 (40.2%) patients in the entire trial period and were primarily low grade (Grade 1-2), all resolved with a median time of two days.
Immune cell-associated neurotoxicity syndrome (ICANS) occurred in seven patients (7.6%), and cases were primarily low grade; all resolved with a median time of three days, and no events led to treatment discontinuation.
The study also demonstrated an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6%, at a median follow-up of 5.8 months in patients who received one prior line of systemic therapy.
In those who had received two or more lines of systemic therapy, there was an ORR of 60.0% and a CR rate of 38.0% after a median follow-up of 10.8 months.
Dr Jeff Sharman, study investigator and disease chair of Hematology Research of Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon, said: “The EPCORE NHL-6 trial results are notable, as current bispecific antibody treatments for relapsed and refractory diffuse large B-cell lymphoma patients may require in-hospital monitoring for cytokine release syndrome after certain initial doses and as needed after subsequent doses.
"The possibility of treating patients in the outpatient setting is encouraging, and it may enable more people to have access to this treatment option across various sites of care, including community settings.”
GlobalData forecasts Epkinly will hit blockbuster status in 2027, accelerating to $2.32bn in sales in 2031.
GlobalData is the parent company of Clinical Trials Arena.
The T-cell-engaging bispecific antibody was first approved in r/r DLBCL by the US Food and Drug Administration (FDA) in May 2023. It is currently administered as an injection in the inpatient setting.
The drug has also been granted accelerated approval by the FDA in June 2024 for its use in third-line treatment in follicular lymphoma (FL). In August 2025, the drug showed promise as a second-line FL therapy.
Other therapies approved in DLBCL include Gilead’s Yescarta (axicabtagene ciloleucel) and Roche’s MabThera (rituximab).
B-cell lymphoma accounts for approximately 80%-85% of non-Hodgkin lymphoma (NHL) cases, with DLBCL the most prevalent of these, accounting for 33%-51% of cases.
