Genmab Announced Investigational Epcoritamab Combination Therapy Demonstrates High Response Rates In Clinical Trial Of Patients With Relapsed Or Refractory Follicular Lymphoma At ASH Meeting; Results Show 96% Overall Response Rate
Genmab Announced Investigational Epcoritamab Combination Therapy Demonstrates High Response Rates In Clinical Trial Of Patients With Relapsed Or Refractory Follicular Lymphoma At ASH Meeting; Results Show 96% Overall Response Rate
Genmab A/S(NASDAQ:GMAB) today announced new results from the Phase 1b/2 EPCORE NHL-2 trial evaluating fixed-duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The results demonstrated an overall response rate (ORR) of 96 percent and a complete response (CR) rate of 87 percent among 111 patients after a median follow-up of two years. Additionally, the study showed an estimated 21-month progression-free survival (PFS) rate of 80 percent and a two-year overall survival (OS) rate of 90 percent. The data (Abstract #342) were shared today during an oral presentation at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH).
genmab A/S(纳斯达克:GMAB)今天宣布了来自1b/2期EPCORE NHL-2试验的新结果，该试验评估了以固定持续时间给药的epcoritamab，这是一种在皮下给药的t细胞接合双特异性抗体，以及lenalidomide + rituximab (R2)，用于治疗成人复发性或难治性（R/R）滤泡性淋巴瘤（FL）的患者。结果显示，111名患者的总体反应率（ORR）为96％，完全反应（CR）率为87％，中位随访两年。此外，该研究显示估计21个月的无进展生存期（PFS）率为80％，两年的总体生存率（OS）为90％。这些数据（摘要＃342）今天在美国血液学会（ASH）第66届年会的口头报告中分享。
- Results show 96 percent overall response rate (ORR), 87 percent complete response (CR), and 80 percent 21-month progression-free survival (PFS) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) following treatment with epcoritamab plus lenalidomide + rituximab (R2)
- Long-term follow-up results demonstrated strong and durable efficacy, with an estimated two-year overall survival (OS) rate of 90 percent
- Results follow recent breakthrough therapy designation (BTD) granted by U.S. Food and Drug Administration (FDA) and support ongoing Phase 3EPCORE FL-1 trial evaluating epcoritamab + R2 in patients with R/R FL
- 结果显示，复发性或难治性（R/R）滤泡性淋巴瘤（FL）患者在接受epcoritamab加上lenalidomide + rituximab (R2)治疗后，整体反应率（ORR）为96％，完全反应（CR）为87％，21个月的无进展生存率（PFS）为80％。
- 长期随访结果显示疗效强劲且持久，估计两年的总体生存率（OS）为90％。
- 结果跟随美国食品和药物管理局（FDA）最近授予的突破性疗法指定（BTD），并支持正在进行的3期EPCORE FL-1试验，该试验正在评估epcoritamab + R2在复发性或难治性（R/R）滤泡性淋巴瘤（FL）患者中的应用。
