Agenus Loses More Than 50% Value On Thursday - Here's Why
Agenus Loses More Than 50% Value On Thursday - Here's Why
Agenus previously disclosed data from the Phase 1 trial, which showed an overall response rate (ORR) of 23% in the 77 MSS mCRC patients without active liver metastases, with a median follow-up of 13.6 months.Agenus Inc. (NASDAQ:AGEN) stock is trading lower on Thursday, with a session volume of 6.29 million, according to data from Benzinga Pro.
据Benzinga Pro的数据显示，Agenus Inc.（纳斯达克代码：AGEN）股票周四交易较低，成交量为629万手。
The company announced the results of its end-of-Phase 2 (EOP2) meeting with the FDA to advance its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for adult patients with relapsed/refractory microsatellite-stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).
该公司宣布与FDA的2期终止会议结果，以推进其免疫疗法组合botensilimab（BOT）和balstilimab（BAL）治疗成人复发/难治性微卫星稳定结直肠癌（r/r MSS CRC）且无活跃肝转移（NLM）的患者。
The FDA discouraged the accelerated approval pathway and advised against submitting these results to support an Accelerated Approval based on its view that objective response rates may not translate to survival benefits.
FDA反对加速批准道路，建议不要提交这些结果以支持基于客观反应率（ORR）的加速批准，因为其认为客观反应率可能无法转化为生存益处。
Agenus previously disclosed data from the Phase 1 trial, which showed an overall response rate (ORR) of 23% in the 77 MSS mCRC patients without active liver metastases, with a median follow-up of 13.6 months.
Agenus此前披露了一期试验的数据，显示77名MSS mCRC患者的ORR为23％，其中没有活跃的肝转移，随访时间中位数为13.6个月。
The estimated 6-month, 12-month, and 18-month overall survival (OS) rates were 86%, 71%, and 62%, respectively. The estimated median OS was 21.2 months.
预计6个月、12个月和18个月的总生存率（OS）分别为86％、71％和62％。预计OS的中位数为21.2个月。
Topline interim data from the Phase 2 trial show trends consistent with the Phase 1 study, including an ORR of 19.4% and a 6-month survival rate of 90% for the BOT 75mg/BAL combination.
二期试验的拓扑线 interim 数据表明包括BOT 75mg/BAL组合在内的一期研究趋势一致，其中ORR为19.4％，6个月存活率为90％。
The safety profile was manageable, and no new signals were observed.
安全性良好，未观察到新的信号。
Agenus plans to explore opportunities to partner in the U.S. to accomplish a successful Phase 3 trial.
Agenus计划探索在美国合作伙伴的机会，以完成成功的3期试验。
In addition to the progress in the U.S., Agenus is advancing its efforts to bring BOT/BAL to patients in Europe.
除在美国的进展外，Agenus还在推进其为欧洲患者带来BOT/BAL的努力。
Engagements with the European Regulatory Authority to explore registration paths are scheduled for later this summer.
将于今年夏天晚些时候与欧洲监管机构进行商讨探讨注册路径的问题。
These discussions aim to align on the regulatory path for approval of the BOT/BAL combination in Europe.
这些讨论旨在协调BOT/BAL组合在欧洲的批准监管路径。
Agenus continues to pursue opportunities for BOT/BAL development in earlier lines of CRC and other tumor types where BOT/BAL has demonstrated clinical activity, such as lung, melanoma, and pancreatic cancers.
Agenus继续追求BOT/BAL在早期的CRC和其他瘤类型的开发机会，在那里BOT/BAL已经展示了临床活性，例如肺癌、黑色素瘤和胰腺癌。
The company expects to present data from some of these programs at future medical congresses, including BOT/BAL in sarcoma at the European Society for Medical Oncology in September 2024.
该公司预计将在未来的医学会议上介绍其中一些项目的数据，包括2024年9月欧洲医学肿瘤学会上BOT/BAL在肉瘤的研究。
Price Action: AGEN shares are down 53.20% at $8.27 at the last check on Thursday.
股价表现：周四，AGEN股价下跌53.20％，报8.27美元。