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(納斯達克:GMAB)今天宣佈了來自1b/2期EPCORE NHL-2試驗的新結果，該試驗評估了以固定持續時間給藥的epcoritamab，這是一種在皮下給藥的t細胞接合雙特異性抗體，以及lenalidomide + rituximab (R2)，用於治療成人複發性或難治性（R/R）濾泡性淋巴瘤（FL）的患者。結果顯示，111名患者的總體反應率（ORR）爲96％，完全反應（CR）率爲87％，中位隨訪兩年。此外，該研究顯示估計21個月的無進展生存期（PFS）率爲80％，兩年的總體生存率（OS）爲90％。這些數據（摘要＃342）今天在美國血液學會（ASH）第66屆年會的口頭報告中分享。
- 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
- 結果顯示，複發性或難治性（R/R）濾泡性淋巴瘤（FL）患者在接受epcoritamab加上lenalidomide + rituximab (R2)治療後，整體反應率（ORR）爲96％，完全反應（CR）爲87％，21個月的無進展生存率（PFS）爲80％。
- 長期隨訪結果顯示療效強勁且持久，估計兩年的總體生存率（OS）爲90％。
- 結果跟隨美國食品和藥物管理局（FDA）最近授予的突破性療法指定（BTD），並支持正在進行的3期EPCORE FL-1試驗，該試驗正在評估epcoritamab + R2在複發性或難治性（R/R）濾泡性淋巴瘤（FL）患者中的應用。
譯文內容由第三人軟體翻譯。
