WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced new early clinical data for INCB123667, a highly selective, potential first-in-class CDK2 inhibitor, in patients with advanced solid tumors. The trial results, presented during a mini-oral presentation at the European Society of Medical Oncology (ESMO) with new, updated data shared during the Company’s investor event, highlight the potential of INCB123667 as a differentiated treatment option for cancers with increased Cyclin E1 activity, amplification and/or overexpression in cells predictive of CDK2 dependency..

特拉华州威尔明顿（商业新闻短讯）--Incyte（纳斯达克：INCY）今天宣布了INCB123667的新的早期临床数据，INCB123667是一种高度选择性，潜在的一流CDK2抑制剂，用于晚期实体瘤患者。该试验结果在欧洲肿瘤内科学会（ESMO）的一次小型口头报告中介绍，并在该公司的投资者活动期间共享了新的最新数据，突显了INCB123667作为细胞周期蛋白E1活性增加，细胞扩增和/或过表达预测CDK2依赖性的癌症的分化治疗选择的潜力。。

In the trial, patients with advanced or metastatic solid tumors (n=205) – including ovarian cancer, endometrial cancer, gastrointestinal cancer, HR+/HER2- breast cancer and triple negative breast cancer, among others – received varying doses of INCB123667 ranging from 50mg to 150mg using once-daily (QD) and twice-daily (BID) dosing schedules..

在该试验中，患有晚期或转移性实体瘤（n=205）的患者（包括卵巢癌，子宫内膜癌，胃肠道癌，HR+/HER2乳腺癌和三阴性乳腺癌等）接受了不同剂量的INCB123667，剂量范围从50mg到150mg，每天一次（QD）和每天两次（BID）给药方案。。

New data from the Phase 1b dose expansion portion of the trial (data cut-off August 26, 2024) presented today during Incyte’s investor event, demonstrate single-agent antitumor activity, and decreases in circulating tumor DNA (ctDNA) across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1.

今天在Incyte的投资者活动期间，来自试验1b期剂量扩展部分的新数据（数据截止日期为2024年8月26日）显示了单药抗肿瘤活性，并且在一系列剂量和方案中循环肿瘤DNA（ctDNA）减少，特别是在肿瘤过表达细胞周期蛋白E1的卵巢癌和子宫内膜癌患者中。

The trial is ongoing, and the data will continue to mature..

试验正在进行中，数据将继续成熟。。

Of the 37 evaluable participants with platinum-resistant ovarian cancer treated at three (3) selected dose levels (50mg BID, 100mg QD and 125mg QD) in the expansion portion of the trial, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]).

在试验的扩大部分，在三（3）个选定剂量水平（50mg BID，100mg QD和125mg QD）治疗的37名铂类耐药卵巢癌可评估参与者中，9名参与者（24.3%）经历了总体反应（OR；2个完全反应[CR]和7个部分反应[PR]）。

The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer..

在50mg BID队列（16名可评估参与者）中发现最高OR率为31.3%（5名应答者，包括2名CR）。此外，卵巢癌患者的疾病控制率（DCR）为75.7%（28/37）。。

In addition, 4 PRs were reported among patients with endometrial cancer.

此外，在子宫内膜癌患者中报告了4例PR。

“The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer. We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options,” said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte.

“INCB123667的早期临床活性代表了卵巢癌患者令人兴奋和有希望的突破。我们相信这种新型CDK2抑制剂有可能成为铂类耐药卵巢癌的基础治疗方法，为目前治疗选择有限的患者提供新的分化治疗，”Incyte研究与开发负责人Pablo Cagnoni医学博士说。

“We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination.”.

“我们期待着推动INCB123667作为单一药物和联合药物治疗卵巢癌患者的发展。”。

The Part 1b data build on results from the dose escalation portion (Part 1a) of the trial evaluating the safety and tolerability of INCB123667 presented during a mini-oral presentation (Mini oral session: Developmental therapeutics) at ESMO.

第1b部分的数据建立在试验剂量递增部分（第1a部分）的结果基础上，该试验评估了在ESMO的小型口服介绍（小型口服会议：发育疗法）期间呈现的INCB123667的安全性和耐受性。

Results from the Part 1a dose escalation portion of the trial (data cut-off July 15, 2024) include:

试验第1a部分剂量递增部分的结果（2024年7月15日数据截止）包括：

INCB123667 demonstrated a manageable safety profile (n=84). The most common hematologic treatment-related adverse events (TRAEs) were thrombocytopenia (35%, 13% Grade 3), anemia (30%, 7% Grade 3) and neutropenia (26%, 8% Grade 3). The most common non-hematologic TRAEs were nausea (42%), fatigue (23%) and vomiting (17%); all of which were Grade 1 and 2 except one case of Grade 3 vomiting and one case of Grade 3 fatigue..

INCB123667表现出可控的安全性（n=84）。最常见的血液学治疗相关不良事件（TRAEs）是血小板减少症（35%，13%3级），贫血（30%，7%3级）和中性粒细胞减少症（26%，8%3级）。；除1例3级呕吐和1例3级疲劳外，其余均为1级和2级。。

Strong selective inhibition of CDK2 was observed resulting in circulating tumor DNA (ctDNA) reduction at all dose levels. During dose escalation, 39 out of 48 patients who had ctDNA measurements at cycle 1, day 1 and cycle 2, day 1 showed reductions in ctDNA.

观察到CDK2的强烈选择性抑制，导致在所有剂量水平下循环肿瘤DNA（ctDNA）减少。在剂量递增期间，在第1周期第1天和第2周期第1天进行ctDNA测量的48名患者中，有39名显示ctDNA减少。

“Results from this study presented today at ESMO reinforce the idea that the novel and highly selective CDK2 inhibitor INCB123667 may provide a potential new treatment option for cancers with increased Cyclin E1 signaling (CCNE1 amplification and Cyclin E1 overexpression), predictive of CDK2 dependency,” said Dr.

“今天在ESMO上发表的这项研究结果强化了这一观点，即新型高选择性CDK2抑制剂INCB123667可能为细胞周期蛋白E1信号传导增加（CCNE1扩增和细胞周期蛋白E1过表达）的癌症提供潜在的新治疗选择，预测CDK2依赖性，”Dr。

Matteo Simonelli, Head of Early-Drug Development in Solid Tumors at IRCCS Humanitas Research Hospital. “The data speak to the potential of INCB123667 as an active and selective targeted therapy for different cancer types, particularly ovarian cancer, and I look forward to seeing further results in later stages of development.”.

。“这些数据说明了INCB123667作为针对不同癌症类型（尤其是卵巢癌）的积极和选择性靶向治疗的潜力，我期待在以后的发展阶段看到进一步的结果。”。

The study is ongoing. Plans are underway to initiate a pivotal study in ovarian cancer next year and evaluate INCB123667 in combination with other treatments.

这项研究正在进行中。正在计划明年启动一项卵巢癌关键研究，并结合其他治疗方法对INCB123667进行评估。

Conference Call and Webcast Information

电话会议和网络广播信息

Incyte will host an in-person analyst and investor event today 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 will include updated results from a later data cut-off, as well as the data included in the ESMO accepted abstract and mini-oral presentation..

Incyte将于美国东部时间今天下午1:00-2:30（CEST下午7:00-8:30）举办一场分析师和投资者面对面的活动，讨论ESMO的关键数据演示，包括POD1UM-303总统座谈会及其CDK2抑制剂计划的数据。CDK2数据将包括后来数据截止的更新结果，以及ESMO接受的摘要和小型口头演示中包含的数据。。

To access the conference call, please dial 877-407-8037 for domestic callers or +1 201-689-8037 for international callers. When prompted, provide the conference identification number, 13748627.

国内电话请拨打877-407-8037，国际电话请拨打+1201-689-8037。出现提示时，请提供会议标识号13748627。

The conference call will also be webcast live and can be accessed at investor.incyte.com.

电话会议也将进行网络直播，可访问investor.incyte.com。

About the Trial (NCT05238922)

关于审判（NCT05238922）

This open-label, dose-escalation and dose-expansion Phase 1 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of INCB123667 when administered as monotherapy at the recommended dose for expansion (RDE[s]) in participants with selected advanced or metastatic solid tumors.

这项开放标签，剂量递增和剂量扩展的第一阶段研究正在评估INCB123667在选定的晚期或转移性实体瘤患者中以推荐的扩展剂量（RDE[s]）作为单一疗法给药时的安全性，耐受性，药代动力学，药效学和初步疗效。

Part 1A (dose escalation) determined the recommended dose of INCB123667 for expansion and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in six tumor-specific cohorts at the RDEs defined in Part 1A..

第1A部分（剂量递增）确定了INCB123667用于扩张的推荐剂量和最大耐受剂量（MTD）。第1B部分（队列剂量扩展阶段）将进一步探索INCB123667的抗肿瘤活性，作为第1A部分定义的RDE的六个肿瘤特异性队列中的单一疗法。。

For more information about the study, please visit: https://clinicaltrials.gov/study/NCT05238922.

有关该研究的更多信息，请访问：https://clinicaltrials.gov/study/NCT05238922.

About INCB123667

AbutICB123667

INCB123667 is a novel, potent and selective oral small molecule inhibitor of CDK2 which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models. Cyclin E amplification and overexpression has been reported to be associated with CDK4/6 resistance and poor clinical outcomes in ovarian, gastric, endometrial and breast cancers.

INCB123667是一种新型，有效且选择性的CDK2口服小分子抑制剂，已被证明在细胞周期蛋白E扩增的肿瘤模型中，作为单一疗法并结合标准治疗可抑制肿瘤生长。据报道，细胞周期蛋白E的扩增和过表达与卵巢癌，胃癌，子宫内膜癌和乳腺癌的CDK4/6耐药性和不良临床结果有关。

INCB123667 has the potential to be a highly targeted and efficacious treatment for advanced solid tumors, including gynecologic tumors, endometrial, uterine, gastric and triple negative breast cancer, among others..

INCB123667有可能成为晚期实体瘤的高度靶向和有效的治疗方法，包括妇科肿瘤，子宫内膜癌，子宫癌，胃癌和三阴性乳腺癌等。。

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 for Incyte’s CDK2 inhibitor (INCB123667), the potential this CDK2 inhibitor offers for patients, and expectations regarding ongoing and future clinical trials contain predictions, estimates, and other forward-looking statements..

除了此处列出的历史信息外，本新闻稿中列出的事项，包括有关Incyte CDK2抑制剂（INCB123667）数据介绍的声明，该CDK2抑制剂为患者提供的潜力，以及对正在进行和未来临床试验的期望，都包含预测，估计和其他前瞻性陈述。。

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；宣布或意外的价格监管或限制对我们产品的报销或覆盖范围的影响；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；以及我们向美国提交的报告中不时详述的其他风险。

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。。