AbbVie/Genmab's Epkinly FDA Approval Is A Positive Step, Analyst Says Additional Expansion Opportunities Underway
AbbVie/Genmab's Epkinly FDA Approval Is A Positive Step, Analyst Says Additional Expansion Opportunities Underway
On Wednesday, the FDA approved Epkinly (epcoritamab-bysp) as the first and only T-cell-engaging bispecific antibody administered subcutaneously for adults with relapsed or refractory follicular lymphoma (r/r F) after two or more lines of prior therapy.
FDA已在星期三批准Epkinly（epcoritamab-bysp）作爲第一個且唯一的經皮給藥的T細胞結合雙特異性抗體，用於經過兩種或兩種以上治療方案而復發或難治的毛髮狀淋巴瘤（r /r F）患者。
Epcoritamab is being co-developed by AbbVie Inc. (NYSE:ABBV) and Genmab A/S (NASDAQ:GMAB) as part of their oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
Epcoritamab由AbbVie股份有限公司（NYSE：ABBV）和genmab A/S（NASDAQ：GMAB）共同開發，作爲它們腫瘤學合作項目的一部分。兩家公司將在美國和日本分享商業責任，而AbbVie則負責進一步實現全球商業化。
The indication is approved under the FDA's Accelerated Approval program based on overall response rate (ORR) and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
該適應症基於總體反應率（ORR）和反應的持久性，已獲得FDA加速批准計劃的批准。對於這種適應症的繼續批准可能取決於在確認試驗中驗證和描述臨床利益。
About 15,000 people develop FL each year in the U.S., and it is considered incurable with current standard-of-care therapies.
約有15,000人每年在美國患有FL，它被認爲是目前標準治療方案難以治癒的疾病。
FDA approval is based on Phase 1/2 EPCORE NHL-1 clinical trial results. The study results showed an ORR – the study's primary endpoint − of 82%, a complete response (CR) rate of 60%, and a partial response (PR) rate of 22%.
FDA批准基於階段1/2 EPCORE NHL-1臨床試驗結果。研究結果顯示ORR-研究的主要終點爲82％，完全緩解（CR）率爲60％，部分緩解（PR）率爲22％。
At a median follow-up of 14.8 months among responders, more than half of the patients who responded to treatment in the study remained responsive to treatment (i.e., the median duration of response was not reached).
在響應患者的中位隨訪時間爲14.8個月的情況下，超過一半的患者仍對治療保持響應狀態（即，響應持續時間中位數沒有被達到）。
A separate dose optimization cohort evaluated 86 patients at the recommended 3-step dosage schedule for CRS mitigation.
一個單獨的劑量優化隊伍，評估了推薦的3步劑量計劃用於減輕CRS的病人86位。
The first full dose of this 3-step regimen did not require mandatory hospitalization. No grade 3 CRS was observed in patients with FL who received EPKINLY with the 3-step-up dosage schedule.
這個3步驟的計劃的第一個完整劑量不需要強制住院。FL患者接受EPKINLY並使用3步升劑量計劃未觀察到3級CRS。
William Blair writes that the approval supports Epkinly's long-term growth potential. Expansion opportunities in additional indications and earlier lines of lymphoma treatment are underway and recent data at ASCO and EHA have shown encouraging results.
William Blair認爲，該批准支持Epkinly的長期增長潛力。在其他適應症和早期淋巴瘤治療領域的擴張機會正在進行中，ASCO和EHA的最新數據顯示了令人鼓舞的結果。
The analyst highlights that Epkinly's market potential is constrained by its limited application to later-line lymphoma and Roche Holdings AG's (OTC:RHHBY) Lunsumio's first-mover advantage in similar outpatient settings.
分析師強調，Epkinly的市場潛力受到其僅限於後期淋巴瘤應用和羅氏控股有限公司（OTC：RHHBY）Lunsumio在類似門診設置中的先行優勢的限制。
William Blair maintains a Market Perform rating for Epkinly, awaiting further indication expansion and clinical updates from its pipeline, including new data for BioNTech SE's (NASDAQ:BNTX) acasunlimab and comparative data with GEN3014 against Johnson & Johnson's (NYSE:JNJ) Darzalex expected later this year.
William Blair維持Epkinly的市場表現評級，等待其管道的進一步適應症擴展和臨床更新，包括BioNTech SE的搜索sunlimab和根治3014針對預計在今年晚些時候公佈的Johnson＆Johnson的Darzalex的比較數據。
Price Action: GMAB shares are down 0.31% at $25.59, and ABBV shares are down 1.57% at $168.47 at the last check on Thursday.
星期四最後一次檢查時，GMAB股票下跌0.31％至25.59美元，ABBV股票下跌1.57％至168.47美元。
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