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).
週五，Incyte公司（納斯達克：INCY）發佈了關鍵的3期inMIND試驗的頭條結果，該試驗評估了Monjuvi（tafasitamab）和來那度胺作爲補充利妥昔單抗與單獨使用來那度胺作爲補充利妥昔單抗的復發或難治性濾泡性淋巴瘤或復發或難治性淋巴結、脾臟或非淋巴結邊緣帶淋巴瘤患者的療效和安全性。
The study enrolled 654 adults.
該研究招募了654名成年人。
The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment in follicular lymphoma.
該試驗達到了在濾泡性淋巴瘤中的調查員評估下的無進展生存期（PFS）的主要終點。
Also Read: FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication.
另外閱讀：FDA批准Incyte公司/Syndax合作開發的藥物用於慢性移植物抗宿主病，一種移植後的併發症。
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.
研究也滿足了關鍵的次要終點，即整體人群中的調查員評估PFS和FDG-着體FL人群的正電子發射斷層掃描-完全緩解率。
In addition, the secondary endpoint of PFS results by the blinded independent review is consistent with investigator-based PFS results.
此外，盲目獨立回顧的PFS結果的次要終點與研究員基於PFS結果一致。
No new safety signals with tafasitamab were observed.
tafasitamab的任何新的安全信號都沒有被觀察到。
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.
濾泡性淋巴瘤是B細胞非何傑金淋巴瘤（NHL）中最常見的慢性生長形式，約佔整體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.
針對每年在美國、歐洲和日本治療的超過17,000例複發性或難治性濾泡性淋巴瘤患者，治療選擇有限。
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預計到年底爲至少接受一次系統性抗CD20免疫治療或化療免疫治療的濾泡性淋巴瘤患者提交tafasitamab的補充營銷申請。
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，美國食品藥品監督管理局和歐洲藥品管理局分別批准了tafasitamab與來那度胺聯合用於成年複發性或難治性瀰漫大B細胞淋巴瘤（DLBCL），包括起源於低級別淋巴瘤的DLBCL患者，不適宜自體幹細胞移植。
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報告稱，2024年2月收購tafasitamab全球獨家權利後，Minjuvi/Monjuvi第二季度銷售額爲3112萬美元，同比增長136％。
Price Action: INCY stock is up 1.82% at $62.80 during the premarket session at last check Friday.
價格行動：截至上週五，正在預測中的股票Incyte股價上漲1.82％至每股62.80美元。
- PepsiCo Faces Legal Heat: Gatorade Protein Bars Criticized For Excessive Sugar
- 百事可樂面臨法律壓力：Gatorade蛋白質棒因含糖過多受到批評。
Photo: Shutterstock
Photo: shutterstock