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）作为第一个且唯一的经皮给药的T细胞结合双特异性抗体，用于经过两种或两种以上治疗方案而复发或难治的毛发状淋巴瘤（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）共同开发，作为它们肿瘤学合作项目的一部分。两家公司将在美国和日本分享商业责任，而AbbVie则负责进一步实现全球商业化。
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).
该适应症基于总体反应率（ORR）和反应的持久性，已获得FDA加速批准计划的批准。对于这种适应症的继续批准可能取决于在确认试验中验证和描述临床利益。
About 15,000 people develop FL each year in the U.S., and it is considered incurable with current standard-of-care therapies.
约有15,000人每年在美国患有FL，它被认为是目前标准治疗方案难以治愈的疾病。
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批准基于阶段1/2 EPCORE NHL-1临床试验结果。研究结果显示ORR-研究的主要终点为82％，完全缓解（CR）率为60％，部分缓解（PR）率为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).
在响应患者的中位随访时间为14.8个月的情况下，超过一半的患者仍对治疗保持响应状态（即，响应持续时间中位数没有被达到）。
A separate dose optimization cohort evaluated 86 patients at the recommended 3-step dosage schedule for CRS mitigation.
一个单独的剂量优化队伍，评估了推荐的3步剂量计划用于减轻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.
这个3步骤的计划的第一个完整剂量不需要强制住院。FL患者接受EPKINLY并使用3步升剂量计划未观察到3级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认为，该批准支持Epkinly的长期增长潜力。在其他适应症和早期淋巴瘤治疗领域的扩张机会正在进行中，ASCO和EHA的最新数据显示了令人鼓舞的结果。
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.
分析师强调，Epkinly的市场潜力受到其仅限于后期淋巴瘤应用和罗氏控股有限公司（OTC：RHHBY）Lunsumio在类似门诊设置中的先行优势的限制。
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维持Epkinly的市场表现评级，等待其管道的进一步适应症扩展和临床更新，包括BioNTech SE的搜索sunlimab和根治3014针对预计在今年晚些时候公布的Johnson＆Johnson的Darzalex的比较数据。
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.
星期四最后一次检查时，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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