At the 2023 American Society of Clinical Oncology (ASCO) meeting, Reid Merryman, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, shared pooled analyses of 2 cohorts from the ongoing phase 1/2 EPCORE NHL-2 trial, assessing the anti-tumor activity and safety of subcutaneous T-cell–engaging bispecific antibody epcoritamab plus rituximab and lenalidomide (R²) among patients with high-risk follicular lymphoma (FL) across multiple subgroups.  

Transcript: 

My name is Reid Merryman. I'm one of the lymphoma clinical investigators at Dana-Farber. This year at ASCO, I presented updated results from a trial testing the combination of epcoritamab plus R² in patients with relapsed/refractory (R/R) follicular lymphoma, with a particular interest in high-risk patient subgroups. 

Each of those 3 drugs—epcoritamab, rituximab, and lenalidomide—has a different mode of action. It was hypothesized that the immunomodulatory properties of lenalidomide might enhance the activity of epcoritamab. 

In this study, all patients received 12 cycles of R² using standard dosing, and 2 different epcoritamab dosing strategies were tested, with more frequent [epcoritamab] dosing in arm 2a, and less frequent dosing in arm 2b. In total, 111 patients were treated. They'd received a median of 1 prior line of therapy. In this trial, there were many high-risk patients.

About 60% of patients had stage 4 disease, about 40% of patients had [progression within 24 months] (POD24) and about 60% of patients had a high-risk [Follicular Lymphoma International Prognostic Index (FLIPI)] score. The safety profile in these updated results was similar to prior reports. 

The most common adverse events were infections, neutropenia, and cytokine release syndrome (CRS). CRS occurred in about half of patients and was almost entirely low grade, with about 2% of patients having grade 3 CRS. CRS occurred over a predictable timeline, with almost all CRS occurring within the first cycle, and most CRS occurring on the first day when the full dose of epcoritamab was given on cycle 1, day 15. 

In terms of anti-tumor activity, the overall response rate was 98%, and the complete response rate was 87%, both of which were very high for this disease setting. Notably, high response rates were seen across all patient subgroups, including those with high-risk features like POD24, primary refractory disease, and high FLIPI scores. The median follow-up was a little bit over 11 months. The 1-year progression-free survival was 78%, and the 1-year duration of complete response was 89%. 

Again, across all different patient subgroups, responses appeared to be durable. In total, these data suggest that this combination is highly active and has a manageable safety profile. Based on these encouraging results, there's an ongoing phase 3 trial that's comparing R² to R² plus epcoritamab in patients with relapsed or refractory follicular lymphoma. More broadly, this study adds to a growing list of trials that suggest that these CD3-CD20 bispecific antibodies are highly active drugs that will likely play an important role in the treatment of follicular lymphoma in the years to come. Thank you.

Source:

Merryman R, Belada D, Sureda A, et al. Epcoritamab + R² regimen and responses in high-risk follicular lymphoma, regardless of POD24 status. Presented at ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. Abstract 7506.