Higher EO2463-induced CD8 T-cell expansion was associated with significantly longer PFS in indolent non-Hodgkin lymphoma.
The in vivo immune therapy EO2463 produced CD8 T-cell expansion that was statistically significantly associated with improved efficacy outcomes in patients with indolent non-Hodgkin lymphoma managed in the watch-and-wait setting, according to new interim data from the phase 1/2 SIDNEY trial (NCT04669171) presented at the 2026 Pan Pacific Lymphoma Conference.¹
In the EO2463 monotherapy cohort, increased CD8 T-cell expansion was correlated with statistically significant improvements in progression-free survival (PFS; HR, 0.18; 95% CI, 0.03-0.82; log-rank P = .020). In the cohort of patients with relapsed/refractory disease who were treated with EO2463 plus lenalidomide (Revlimid) and rituximab (Rituxan), higher CD8 T-cell expansion was also correlated with significant improvements in complete response (CR) rate (P = .0073).¹
Investigators noted that the findings extend earlier biomarker data and support further development of EO2463-induced CD8 T-cell expansion as a predictive biomarker of clinical benefit across the monotherapy and combination settings.
“The correlation between the robust CD8 T-cell expansion induced by EO2463 and PFS is a landmark finding that creates an imperative for further study and offers new hope for patients suffering from indolent non-Hodgkin lymphoma,” Pierre Belichard, chief executive officer of Enterome, stated in a news release. “These data suggests that EO2463, which has been well-tolerated to date, may effectively extend PFS as a standalone therapy without hurting quality of life in this generally older and fragile patient population.”
The open-label trial enrolled patients who were at least 18 years of age and human leukocyte antigen-A2 positive.2 Patients also needed to have radiologically measurable disease defined by a lymph node or tumor mass that was at least 1.5 cm. Disease status and grade as well as ECOG performance status varied by cohort.
If patients had received daily doses of dexamethasone higher than 2 mg within 2 weeks of their first dose, had a high-risk profile, abnormal laboratory values, or uncontrolled central nervous system metastasis, they were not included in the study.
The trial has multiple cohorts, including a watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463 plus lenalidomide and rituximab.¹
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“Based on these and other data, we believe EO2463 is ready to start the final stage of registrational clinical development as a first-in-class therapeutic for patients with indolent non-Hodgkin lymphoma in a watch-and-wait setting,” Belichard said. “We are in active discussions with potential investors and partners to find the best way to bring this product to patients.”
