EPCORE NHL-1 Trial Reveals Promising Response Rates for Investigational Follicular Lymphoma Therapy: A Game-Changing Alternative in Focus

Follicular lymphoma is the second most common form of non-Hodgkin’s lymphoma, which is considered incurable and can be difficult to treat in the R/R setting. EPCORE NHL-1 is a multi-center trial comprising three Phases—Phase I for dose escalation, Phase IIa expansion, and Phase IIa dose optimization. It is an open-label study assessing the safety and preliminary efficacy of subcutaneous epcoritamab in individuals with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL), including follicular lymphoma. The findings presented at the ASH 2023 from the pivotal cohort of 128 adult patients showed that, with a median follow-up of 17.4 months, the primary endpoint of the study, the overall response rate (ORR), surpassed the specified efficacy threshold at 82%, accompanied by a 63% complete response (CR) rate and 67% minimal residual disease (MRD) negativity. In addition to that, rapid responses were observed, with a median time to response of 1.4 months and a median time to CR of 1.5 months. Notably, the median progression-free survival (PFS), duration of response, duration of CR, MRD negativity, and overall survival were not reached for patients achieving a CR. Furthermore, a remarkable 85% and 74% of patients in CR sustained their response at 12 and 18 months, respectively. 

Safety outcomes were in line with previous epcoritamab trials, demonstrating overall good tolerability. With a tailored step-up dose approach for follicular lymphoma patients, 40% experienced Grade 1 CRS, 8 percent Grade 2 (no Grade 3 or higher CRS reported), and no Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). This data suggests potential support for outpatient administration. Other notable treatment-related adverse events (>20%) in the pivotal cohort included injection-site reactions (57%), COVID-19 (40%), fatigue (30%), neutropenia (29%), diarrhea (27%), and pyrexia (25%). Lastly, treatment discontinuation due to adverse events occurred in 19% of patients, with Grade 5 adverse events reported in 13 patients (10%).

KOL Insights

“Despite treatment advances for patients with follicular lymphoma whose disease has unfortunately progressed, treating relapsed or refractory follicular lymphoma remains highly challenging, particularly in the third-line plus setting. The patients in this trial represent a historically difficult-to-treat patient population. The data presented today are especially notable because they demonstrated high overall and complete response rates for this investigational follicular lymphoma therapy and a preview for its potential as an alternative treatment option.” –Expert Opinion.

Conclusion

The findings unveiled in the pivotal Phase I/II EPCORE NHL-1 trial stand out as noteworthy, showcasing elevated overall and complete response rates for this experimental follicular lymphoma therapy. These results offer a glimpse into its potential as a promising alternative treatment option.

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