epcoritamab 治疗复发/难治性大 B 细胞淋巴瘤的疗效与安全性：EPCORE NHL-1 试验 3 年更新

Epcoritamab, a CD3xCD20 bispecific antibody, resulted in deep, durable responses with a manageable safety profile in patients with relapsed/refractory large B-cell lymphoma (LBCL) in EPCORE NHL-1 (NCT03625037).

We report results from a 3-year follow-up. Adults with relapsed/refractory LBCL received epcoritamab until progressive disease or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Median age was 64. 0 years, 39% of patients received prior CAR T-cell treatment, and 75% were refractory to 2 consecutive lines of treatment. As of May 3, 2024 (median follow-up 37. 1 months [range, 0. 3 45. 5]), ORR was 59% and complete response (CR) rate 41% by investigator assessment. Median duration of response was 20. 8 months (95% confidence interval [CI], 13. 0 32. 0). Median duration of CR was 36. 1 months (20. 2 not reached [NR]); the longest ongoing CR was > 43 months. Median progression-free survival was 4.

2 months (95% CI, 2. 8 5. 5) in all patients and 37. 3 months (26. 0 NR) in patients with CR. Median overall survival was 18. 5 months (95% CI, 11. 7 27. 7) in all patients and NR in patients with CR. Of 119 patients evaluable for minimal residual disease (MRD) assessments, 54 (45%) were MRD-negative at any time during the study.

Most common adverse events were cytokine release syndrome (51%), fatigue (25%), and pyrexia (25%), with no new safety signals. Grade 1, 2, and 3 infections occurred in 23%, 34%, and 24% of patients, respectively. The durability of responses and prolonged survival in complete responders suggest long-term disease-free survival with epcoritamab in these patients with relapsed/refractory LBCL.