Incyte Seeks Expanded FDA Approval For Lymphoma Drug After Releasing Promising Topline Data From Late-Stage Study
Incyte Seeks Expanded FDA Approval For Lymphoma Drug After Releasing Promising Topline Data From Late-Stage Study
On Friday, Incyte Corporation (NASDAQ:INCY) released topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of Monjuvi (tafasitamab) and lenalidomide as an add-on to rituximab compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL).
周五，Incyte公司（纳斯达克：INCY）发布了关键的3期inMIND试验的头条结果，该试验评估了Monjuvi（tafasitamab）和来那度胺作为补充利妥昔单抗与单独使用来那度胺作为补充利妥昔单抗的复发或难治性滤泡性淋巴瘤或复发或难治性淋巴结、脾脏或非淋巴结边缘带淋巴瘤患者的疗效和安全性。
The study enrolled 654 adults.
该研究招募了654名成年人。
The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment in follicular lymphoma.
该试验达到了在滤泡性淋巴瘤中的调查员评估下的无进展生存期（PFS）的主要终点。
Also Read: FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication.
另外阅读：FDA批准Incyte公司/Syndax合作开发的药物用于慢性移植物抗宿主病，一种移植后的并发症。
It also met key secondary endpoints of PFS in the overall population by investigator assessment and the positron-emission tomography-complete response rate in the FDG-avid FL population.
研究也满足了关键的次要终点，即整体人群中的调查员评估PFS和FDG-着体FL人群的正电子发射断层扫描-完全缓解率。
In addition, the secondary endpoint of PFS results by the blinded independent review is consistent with investigator-based PFS results.
此外，盲目独立回顾的PFS结果的次要终点与研究员基于PFS结果一致。
No new safety signals with tafasitamab were observed.
tafasitamab的任何新的安全信号都没有被观察到。
Follicular lymphoma is the most common indolent, or slow-growing, form of B-cell non-Hodgkin lymphoma (NHL), accounting for approximately 13-26% of overall NHL cases.
滤泡性淋巴瘤是B细胞非何杰金淋巴瘤（NHL）中最常见的慢性生长形式，约占整体NHL病例的13-26％。
There are limited treatment options for the more than 17,000 new cases of relapsed or refractory Follicular lymphoma treated every year in the United States, Europe, and Japan.
针对每年在美国、欧洲和日本治疗的超过17,000例复发性或难治性滤泡性淋巴瘤患者，治疗选择有限。
Incyte expects to file a supplemental marketing application for tafasitamab by the end of the year for follicular lymphoma patients who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy.
Incyte预计到年底为至少接受一次系统性抗CD20免疫治疗或化疗免疫治疗的滤泡性淋巴瘤患者提交tafasitamab的补充营销申请。
The FDA and the European Medicines Agency approved tafasitamab in combination with lenalidomide in 2020 and 2021, respectively, for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for autologous stem cell transplant.
2020年和2021年，美国食品药品监督管理局和欧洲药品管理局分别批准了tafasitamab与来那度胺联合用于成年复发性或难治性弥漫大B细胞淋巴瘤（DLBCL），包括起源于低级别淋巴瘤的DLBCL患者，不适宜自体干细胞移植。
Incyte reported second quarter Minjuvi/ Monjuvi sales of $31.12 million, up 136% year over year, following the acquisition of the exclusive global rights to tafasitamab in February 2024.
Incyte报告称，2024年2月收购tafasitamab全球独家权利后，Minjuvi/Monjuvi第二季度销售额为3112万美元，同比增长136％。
Price Action: INCY stock is up 1.82% at $62.80 during the premarket session at last check Friday.
价格行动：截至上周五，正在预测中的股票Incyte股价上涨1.82％至每股62.80美元。
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Photo: Shutterstock
Photo: shutterstock