KEY TAKEAWAYS
- The EPCORE™ NHL-2 trial assessed the effectiveness of epcoritamab when combined with rituximab + lenalidomide (R2) in high-risk FL patients.
- Epcoritamab and R2 have shown promising responses and appear safe for patients with relapsed or refractory FL, even those considered high-risk.
The study analyzed epcoritamab combined with rituximab + lenalidomide (R2) from segments 2a and 2b of the ongoing EPCORE™ NHL-2 trial. The study involved patients with a relapsed or non-responsive CD20+ follicular lymphoma (FL). By October 31, 2022, 109 pts were involved in segments 2a and 2b.
Patients were treated with subcutaneous epcoritamab (48 mg) and R2 for 12 cycles, each lasting 28 days. The dosing details for epcoritamab varied between the two study segments and spanned over two years: QW C1–3, Q2W C4–9, Q4W C≥10 (arm 2a); QW C1–2, Q4W C≥3 (arm 2b).
Of the 109 participants, 82% continued the treatment with an average monitoring period of 8.8 months. The majority of patients (pts) had FLIPI 3-5 (56%) and stage IV disease (61%), with a median age of 65. The common treatment-emergent adverse events were cytokine release syndrome (CRS) and neutropenia (48%), injection-site reactions (38%), and fatigue (33%). CRS events were mostly low grade (46% G1-2, 2% G3) and occurred after the first full dose of C1D15.
Fortunately, all events were resolved and did not lead to discontinuation. Two pts experienced immune effector cell-associated neurotoxicity syndrome (G1, G2), but it was resolved. Regarding overall response rates/complete metabolic response rates, 97% and 86% were achieved in efficacy-evaluable pts (n=101). The rates were 95% and 82% in POD24 (n=38), 95% and 90% in POD24 receiving epcoritamab in second line (n=20), 97% and 87% in primary refractory (n=39), 94% and 84% in refractory to prior anti-CD20 treatment (n=49), and 92% and 79% in double refractory (n=39).
The combination of epcoritamab and R2 exhibited promising results and a manageable safety profile for relapsed or non-responsive FL pts, including those at high risk. An additional study for the POD24 group is planned, and the combination’s effectiveness is also under examination in the phase III EPCORE FL-1 trial.
Source: https://clml-soho2023.elsevierdigitaledition.com/454/index.html
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04663347
Merryman, R. W., Belada, D., Sureda, A., Leppä, S., Vermaat, J. S., Holte, H., Hutchings, M., Lugtenburg, P., De Vos, S., Abrisqueta, P., Nijland, M., Christensen, J. H., Wahlin, B. E., Linton, K. M., Wang, L., Abbas, A., Rana, A., Quadri, S., & Falchi, L. (2023). IBCL-474 Epcoritamab + R2 Regimen and Responses in Patients With High-Risk Follicular Lymphoma, Regardless of POD24 Status. Clinical Lymphoma Myeloma and Leukemia, 23, S454. https://doi.org/10.1016/S2152-2650(23)01362-9
