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Incyte将在2024年欧洲医学肿瘤学会(ESMO)大会上展示Retifanlimab(Zynyz®)的最新3期结果和CDK2抑制剂1期项目的初步数据

Incyte to Present Latereaking Phase 3 Results for Retifanlimab (Zynyz ® ) and Initial Data from Phase 1 CDK2 Inhibitor Program at the European Society of Medical Oncology (ESMO) Congress 2024

businesswire 等信源发布 2024-08-21 21:40

可切换为仅中文


WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq: INCY) today announced that the Company will present key data from its oncology portfolio at the upcoming European Society of Medical Oncology (ESMO) Congress 2024, to be held September 13-17 in Barcelona and virtually.

特拉华州威尔明顿(商业新闻短讯)--Incyte(纳斯达克:INCY)今天宣布,该公司将在即将于9月13日至17日在巴塞罗那举行的2024年欧洲肿瘤内科学会(ESMO)大会上展示其肿瘤学投资组合的关键数据。

'The data at ESMO underscore the progress across our oncology portfolio and the potential to impact patients where additional treatment options are needed. Notably, a Presidential Symposium will feature new, pivotal results from the Phase 3 POD1UM-303/InterAACT2 study of retifanlimab (Zynyz®) for the treatment of squamous cell anal carcinoma (SCAC).

“ESMO的数据强调了我们肿瘤学组合的进展,以及在需要额外治疗选择的情况下影响患者的潜力。值得注意的是,总统研讨会将展示retifanlimab(Zynyz®)治疗鳞状细胞肛门癌(SCAC)的3期POD1UM-303/InterAACT2研究的新的关键结果。

The POD1UM-303 data will support the supplemental Biologics License Application (sBLA) filing for retifanlimab in SCAC planned by year end 2024,' said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. 'We will also present new data on INCB123667, a potential first-in-class CDK2 inhibitor, which we believe has the potential to enhance outcomes and serve as a foundational treatment for platinum-resistant ovarian and other cancers.'.

Incyte总裁兼研发负责人巴勃罗·卡格诺尼(PabloCagnoni M.D.)说,POD1UM-303数据将支持计划于2024年底在SCAC提交retifanlimab的补充生物制剂许可证申请(sBLA)我们还将提供有关INCB123667的新数据,INCB123667是一种潜在的一流CDK2抑制剂,我们认为它有可能改善预后,并作为铂类耐药卵巢癌和其他癌症的基础治疗方法。”。

Details on the abstracts accepted for presentation at ESMO include:

ESMO接受的摘要详情包括:

Presidential Symposium

总统座谈会

Retifanlimab (PD-1)

雷蒂凡利马(PD-1)

POD1UM-303/InterAACT2: Phase 3 Study of Retifanlimab With Carboplatin-Paclitaxel (C-P) in Patients (Pts) With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC) Not Previously Treated With Systemic Chemotherapy

POD1UM-303/InterAACT2:Retifanlimab联合卡铂-紫杉醇(C-P)治疗先前未接受全身化疗的无法手术的局部复发或转移性肛管鳞状细胞癌(SCAC)患者的3期研究

Presidential Symposium I: Practice-changing trials. Presentation Number: LBA2. Presentation Time: 10:50-11:02 a.m. ET (4:50-5:02 p.m. CET), September 14, 2024

。演示编号:LBA2。演讲时间:美国东部时间上午10:50-11:02(欧洲中部时间下午4:50-5:02),2024年9月14日

Mini Oral Session

小型口头会议

INCB123667

包括123667

Safety and Tolerability of INCB123667, a Selective CDK2 Inhibitor, in Patients (Pts) With Advanced Solid Tumors: A Phase 1 Study

Mini oral session: Developmental therapeutics. Presentation Number: 617MO. Presentation Time: 9:35 – 9:40 a.m. ET (3:35-3:40 p.m. CET), September 14, 2024

小型口腔会议:发展疗法。演示编号:617MO。演讲时间:美国东部时间上午9:35–9:40(欧洲中部时间下午3:35-3:40),2024年9月14日

Conference Call and Webcast

电话会议和网络广播

Incyte will host an in-person analyst and investor event on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data presentations at ESMO including data from the POD1UM-303 Presidential Symposia and its CDK2 inhibitor program. The CDK2 data presentation will include new results from a later data cut-off, as well as the data included in the ESMO accepted abstract and mini-oral presentation.

Incyte将于2024年9月14日(星期六)下午1:00-2:30(CEST下午7:00-8:30)主持一场面对面的分析师和投资者活动,讨论ESMO的关键数据演示,包括POD1UM-303总统研讨会及其CDK2抑制剂计划的数据。CDK2数据演示将包括后来数据截止的新结果,以及ESMO接受的摘要和小型口头演示中包含的数据。

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 90 days..

该活动将通过网络直播,可通过Incyte.com投资者部分的活动和演示选项卡访问,并可在90天内重播。。

Conference call details will be provided on the Investor section of Incyte.com.

电话会议详情将在Incyte.com的投资者部分提供。

Abstracts will be available to registered attendees on the ESMO Virtual Congress platform beginning on September 9, 2024. All accepted abstracts will be published in the ESMO Congress 2024 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.

自2024年9月9日起,ESMO虚拟大会平台上的注册与会者将可获得摘要。所有被接受的摘要将发表在ESMO大会2024年摘要书中,该书是ESMO官方期刊《肿瘤学年鉴》的补充。

More information regarding the 2024 ESMO Congress can be found at https://www.esmo.org/meeting-calendar/esmo-congress-2024.

有关2024年ESMO大会的更多信息,请访问https://www.esmo.org/meeting-calendar/esmo-congress-2024.

About Retifanlimab (Zynyz®)

关于Retifanlimab(Zynyz®)

Retifanlimab (Zynyz®), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials..

Retifanlimab(Zynyz®)是一种静脉注射PD-1抑制剂,在美国用于治疗转移性或复发性局部晚期默克尔细胞癌(MCC)的成年患者。根据肿瘤反应率和反应持续时间,该适应症在加速批准下获得批准。是否继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。。

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz由Incyte在美国销售。2017年,Incyte与MacroGenics,Inc.就retifanlimab的全球权利签订了独家合作和许可协议。

Zynyz is a trademark of Incyte.

Zynyz是Incyte的商标。

About Incyte

关于Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity.

Incyte是一家全球生物制药公司,其使命是解决on问题,它遵循科学原理,为未满足医疗需求的患者寻找解决方案。通过专有疗法的发现、开发和商业化,Incyte为患者建立了一流的药物组合,并在肿瘤学、炎症和自身免疫领域建立了强大的产品线。

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia..

Incyte总部位于特拉华州的威尔明顿,在北美、欧洲和亚洲都有业务。。

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

有关Incyte的更多信息,请访问Incyte.com或在社交媒体上关注我们:LinkedIn、X、Instagram、Facebook、YouTube。

Incyte Forward-Looking Statements

Incyte前瞻性声明

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the potential for retifanlimab and INCB123667 to positively impact patients and plans to submit an sBLA for retifanlimab in SCAC by year end 2024, contain predictions, estimates, and other forward-looking statements..

除本文所述的历史信息外,本新闻稿中所述事项,包括有关Incyte临床开发管道数据呈现的声明,retifanlimab和INCB123667对患者产生积极影响的潜力以及计划在2024年底前在SCAC提交retifanlimab sBLA的声明,均包含预测、估计和其他前瞻性声明。。

These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S.

这些前瞻性陈述基于我们目前的预期,并受到可能导致实际结果产生重大差异的风险和不确定性的影响,包括意外发展和与以下相关的风险:意外延误;进一步的研究和开发以及临床试验结果可能不成功或不足以满足适用的监管标准或需要继续开发;能够在临床试验中招募足够数量的受试者,并能够按照计划的时间表招募受试者;FDA和美国以外的监管机构做出的决定;我们产品的功效或安全性;我们的产品在市场上的接受程度;市场竞争;我们的产品和合作伙伴的产品需求出现意外变化;宣布或意外的价格法规或限制对我们产品的报销或保险范围的影响;销售、营销、制造和分销要求,包括我们成功商业化和为新批准的产品和任何其他获得批准的新产品建立商业基础设施的能力;。

Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim any intent or obligation to update these forward-looking statements..

美国证券交易委员会(SEC),包括截至2024年6月30日的10-K表年度报告和10-Q表季度报告。我们不承担更新这些前瞻性声明的任何意图或义务。。