Data presented at the European Society for Medical Oncology from the Phase 1/2 trial with bavdegalutamide showed 11.1 months radiographic progression free survival in mCRPC patients with tumors harboring AR 878/875 mutations

欧洲肿瘤内科学会1/2期bavdegalutamide试验的数据显示，携带AR 878/875突变的mCRPC患者的放射学无进展生存期为11.1个月

Interim data from the Phase 1/2 trial of Arvinas’ second PROTAC AR degrader, ARV-766, showed robust efficacy in a broader mCRPC patient population with a tolerability profile well-suited to both early- and late-line settings

来自Arvinas第二个PROTAC AR降解剂ARV-766的1/2期试验的中期数据显示，在更广泛的mCRPC患者群体中具有强大的功效，其耐受性特征非常适合于早期和晚期的设置

Company to prioritize the initiation of a Phase 3 trial with ARV-766 in mCRPC

公司优先考虑在mCRPC中启动ARV-766的3期临床试验

Arvinas will host conference call to discuss results on Sunday, October 22 at 3:00 p.m. CEST / 9:00 a.m. ET

Arvinas将召开电话会议，讨论10月22日星期日下午3:00 CEST/上午9:00的结果

NEW HAVEN, Conn., Oct. 22, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the presentation of interim data from the Company’s Phase 1/2 clinical trial for bavdegalutamide (ARV-110), a novel PROTAC® protein degrader targeting the androgen receptor (AR), in a poster session at the European Society for Medical Oncology Congress being held in Madrid from October 20 – 24, 2023.

康涅狄格州纽黑文，2023年10月22日（GLOBE NEWSWIRE）-Arvinas，Inc。（纳斯达克股票代码：ARVN），一家临床阶段生物技术公司，创建基于靶向蛋白质降解的新型药物，今天宣布介绍该公司针对雄激素受体（AR）的新型PROTAC®蛋白降解剂bavdegalutamide（ARV-110）1/2期临床试验的临时数据，在2023年10月20日至24日在马德里举行的欧洲医学肿瘤学会大会上的海报会议上。

The Company will host a conference call to discuss these data and present new data from an updated analysis of its ongoing Phase 1/2 clinical trial with its second-generation PROTAC AR degrader, ARV-766, showing clinical activity extending across patients harboring tumors with AR LBD mutations and a tolerability profile that is superior to bavdegalutamide..

该公司将召开一次电话会议，讨论这些数据，并从其正在进行的第二代PROTAC AR降解剂ARV-766进行的1/2期临床试验的最新分析中提供新数据，显示临床活动扩展到窝藏肿瘤患者AR LBD突变和耐受性优于bavdegalutamide的耐受性特征。。

Extended follow-up of data from the Phase 1/2 clinical trial with bavdegalutamide showed radiographic progression free survival (rPFS) of 11.1 months in a subgroup of patients with metastatic castration-resistant prostate cancer (mCRPC) and tumors harboring AR T878X/H878Y mutations (AR 878/875; T878X=T878A or T878S) in the absence of co-occurring AR L702H mutations.

使用bavdegalutamide进行的1/2期临床试验数据的延长随访显示，转移性去势抵抗性前列腺癌（mCRPC）和携带AR T878X/H878Y的肿瘤患者亚组的放射学无进展生存期（rPFS）为11.1个月在没有共同发生的AR L702H突变的情况下突变（AR 878/875；T878X=T878A或T878S）。

AR L702H is a common AR ligand-binding domain (LBD) mutation that is not potently degraded by bavdegalutamide. In patients with tumors harboring any AR LBD mutation except L702H alone, bavdegalutamide showed an rPFS of 8.2 months..

AR L702H是常见的AR配体结合域（LBD）突变，不会被bavdegalutamide有效降解。在患有任何AR LBD突变（仅L702H除外）的肿瘤患者中，bavdegalutamide的rPFS为8.2个月。。

'We are incredibly pleased with the results from bavdegalutamide’s Phase 1/2 trial as they demonstrate the promise of our AR PROTAC degraders to help patients with prostate cancer,” said John Houston, Ph.D., chairperson, chief executive officer, and president of Arvinas. “While bavdegalutamide’s efficacy is very exciting, its breadth of activity could be limited to a small patient population in a late-line setting.

“我们对bavdegalutamide 1/2期临床试验的结果感到非常满意，因为它们证明了我们的AR PROTAC降解物有望帮助前列腺癌患者，”John Houston博士，主席，首席执行官和Arvinas总裁说。“虽然bavdegalutamide的疗效非常令人兴奋，但其活动范围可能仅限于晚期患者人群。

Our second generation PROTAC AR degrader, ARV-766, has demonstrated a broader efficacy profile and even better tolerability compared to bavdegalutamide in clinical settings. Arvinas is committed to bringing forward the best PROTAC AR degrader for patients with prostate cancer. We believe ARV-766 has the potential to be a first- and best- in-class treatment for patients with castrate-sensitive and castrate-resistant prostate cancer, and we are prioritizing the initiation of a Phase 3 clinical trial in mCRPC with ARV-766.”.

我们的第二代PROTAC AR降解剂ARV-766与临床环境中的bavdegalutamide相比，具有更广泛的疗效和更好的耐受性。Arvinas致力于为前列腺癌患者提供最佳的PROTAC AR降解剂。我们相信ARV-766有可能成为去势敏感和去势抵抗性前列腺癌患者的一流和一流的治疗方法，我们正在优先考虑用ARV-766在mCRPC中启动3期临床试验“。

Bavdegalutamide is a once-daily, oral, first-in-class PROTAC AR degrader that degrades wild type and all clinically relevant AR LBD mutations except AR L702H. ARV-766 was designed to improve upon the degradation profile of bavdegalutamide by also degrading AR L702H. The prevalence of all AR LBD mutations, especially AR L702H, has increased over time, and these mutations are present in approximately 25% of tumors after initial treatment with a novel hormonal agent (NHA) such as enzalutamide or abiraterone.

Bavdegalutamide是一种每日一次，口服，一流的PROTAC AR降解剂，可降解野生型和除AR L702H外的所有临床相关AR LBD突变。ARV-766旨在通过降解AR L702H来改善bavdegalutamide的降解特性。随着时间的推移，所有AR LBD突变（尤其是AR L702H）的患病率均增加，并且在使用新型激素（NHA）（例如enzalutamide或阿比特龙）进行初始治疗后，这些突变存在于大约25%的肿瘤中。

This represents a potential addressable patient population for ARV-766 that is approximately three times that of bavdegalutamide in the post-NHA population due to its broader degradation profile..

这代表了ARV-766潜在的可寻址患者群体，由于其更广泛的降解特征，其在NHA后群体中大约是bavdegalutamide的三倍。。

New data from the ongoing Phase 1/2 clinical trial of ARV-766 continues to show robust efficacy in tumors with all LBD mutations (41% PSA50) and in patients with tumors harboring AR L702H mutations (50% PSA50). In addition to a tolerability profile that is superior to bavdegalutamide, early durability data for ARV-766 are encouraging and provide additional support for prioritizing ARV-766 over bavdegalutamide, with PFS data anticipated in 2024..

来自正在进行的ARV-766 1/2期临床试验的新数据继续显示在具有所有LBD突变（41%PSA50）的肿瘤和具有AR L702H突变（50%PSA50）的肿瘤患者中的强效功效。除了优于bavdegalutamide的耐受性概况之外，ARV-766的早期耐久性数据令人鼓舞，并为ARV-766优先于bavdegalutamide提供了额外的支持，PFS数据预计在2024年。。

'I’ve been involved in trials with both bavdegalutamide and ARV-766. It’s gratifying to see these innovative therapies developed in advanced prostate cancer where there remains a significant need for better treatments,” said Daniel Petrylak, M.D., Professor of Medicine and Urology at Yale School of Medicine and investigator in the Phase 1/2 studies with bavdegalutamide and ARV-766.

'我曾参与过bavdegalutamide和ARV-766的试验。耶鲁大学医学院医学与泌尿外科教授，研究人员Daniel Petrylak博士在bavdegalutamide和ARV-766的1/2期研究中表示，看到这些创新疗法在晚期前列腺癌中发展，仍然需要更好的治疗方法，这令人欣慰。

“In my experience, these novel therapies have the potential to be an important treatment choice for patients whose tumors harbor androgen receptor LBD mutations, which may be present in up to 25% of metastatic castration resistant prostate cancer. The increasing prevalence of the L702H mutation means that more patients could potentially benefit from the broader efficacy profile offered with ARV-766.

“根据我的经验，这些新疗法有可能成为肿瘤中存在雄激素受体LBD突变的患者的重要治疗选择，这些突变可能存在于高达25%的转移性去势抵抗性前列腺癌中。L702H突变意味着更多的患者可能从ARV提供的更广泛的功效概况中受益-766.

The improvement in tolerability that ARV-766 has shown in clinical trials compared to bavdegalutamide is also a big advantage for patients with prostate cancer.”.

与bavdegalutamide相比，ARV-766在临床试验中显示的耐受性改善对于前列腺癌患者也是一个很大的优势。

Highlights from the Phase 1/2 trial with bavdegalutamide (data cut-off date Aug. 11, 2023):

来自bavdegalutamide的1/2期试验的亮点（数据截止日期为2023年8月11日）：

In a post-NHA (median prior therapies = 4) mCRPC population, bavdegalutamide at the recommend Phase 2 dose (420 mg, oral, once daily) demonstrated:

在NHA后（中位治疗前=4）mCRPC人群中，推荐的2期剂量（420mg，口服，每日一次）的bavdegalutamide显示：

Median rPFS of 11.1 months in patients harboring AR 878/875 mutations and without co-occurring AR L702H mutations (n=26), and median rPFS of 8.2 months in patients with tumors harboring any AR LBD mutation except L702H alone (n=45)

携带AR 878/875突变且未同时发生AR L702H突变的患者中位rPFS为11.1个月（n=26），携带任何AR LBD突变的肿瘤患者中位rPFS为8.2个月（仅L702H除外）（n=45）

PSA50 rates of 54% in patients with tumors harboring AR 878/875 mutations and without co-occurring AR L702H, and 36% in patients with tumors harboring any AR LBD mutation except L702H alone

携带AR 878/875突变且未同时发生AR L702H的肿瘤患者的PSA50率为54%，携带AR LBD突变的肿瘤患者的PSA50率为36%，仅携带L702H的患者除外

The presence of AR L702H mutations greatly diminished the efficacy of bavdegalutamide

AR L702H突变的存在大大降低了bavdegalutamide的疗效

In patients with any tumor harboring an AR L702H mutation, the PSA50 was 8%

在任何携带AR L702H突变的肿瘤患者中，PSA50为8%

Bavdegalutamide had a manageable tolerability profile with no grade ≥ 4 treatment-related adverse events (TRAEs). The most common TRAEs were grade 1 and 2 and included nausea (56%), fatigue (35%), vomiting (33%), decreased appetite (25%) and diarrhea (24%). The discontinuation rate due to TRAEs was 10%..

Bavdegalutamide具有可控的耐受性，没有≥4级治疗相关不良事件（TRAEs）。最常见的TRAEs为1级和2级，包括恶心（56%），疲劳（35%），呕吐（33%），食欲下降（25%）和腹泻（24%）。TRAEs的停药率为10%。。

Interim data from the ongoing Phase 1/2 dose escalation and expansion trial of ARV-766 (data cut-off date Aug. 23, 2023)

来自正在进行的ARV-766 1/2期剂量递增和扩展试验的中期数据（数据截止日期为2023年8月23日）

Data from an updated analysis of the ongoing Phase 1/2 clinical trial demonstrate broad efficacy and excellent tolerability in mCRPC patients with tumors harboring AR LBD mutations, including AR L702H:

来自正在进行的1/2期临床试验的最新分析的数据表明，对于具有AR LBD突变（包括AR L702H）的肿瘤的mCRPC患者，其广泛的疗效和出色的耐受性：

PSA50 of 41% in patients with tumors harboring any AR LBD mutation, and a PSA50 of 50% in patients with any tumor harboring an AR L702H mutation

携带AR LBD突变的肿瘤患者PSA50为41%，携带AR L702H突变的肿瘤患者PSA50为50%

ARV-766 was well-tolerated, with no grade ≥ 4 TRAEs. The most common TRAEs were grade 1 or 2 and included fatigue (29%), nausea (14%), vomiting (11%), and diarrhea (11%). The discontinuation rate due to TRAEs was 4%.

ARV-766耐受性良好，无≥4级TRAEs。最常见的TRAEs为1级或2级，包括疲劳（29%），恶心（14%），呕吐（11%）和腹泻（11%）。TRAEs停药率为4%。

Based on ARV-766’s superior tolerability profile and encouraging efficacy data to date, Arvinas believes ARV-766 will be a superior PROTAC AR degrader versus bavdegalutamide for both metastatic castration-sensitive prostate cancer (mCSPC) and mCRPC. Arvinas will prioritize the initiation of a Phase 3 clinical trial with ARV-766 in mCRPC instead of the previously planned Phase 3 clinical trial for bavdegalutamide.

基于ARV-766优越的耐受性和令人鼓舞的疗效数据，Arvinas认为ARV-766对于转移性去势敏感性前列腺癌（mCSPC）和mCRPC都是优于PROTAC AR降解剂和bavdegalutamide的。Arvinas将优先考虑在mCRPC中启动ARV-766的3期临床试验，而不是之前计划的bavdegalutamide 3期临床试验。

The Company will initiate discussions with regulatory authorities by 2Q 2024..

公司将于2024年2月2日前与监管机构进行讨论。。

Bavdegalutamide Phase 1/2 Poster Presentation

Bavdegalutamide阶段1/2海报展示

Data from the Phase 1/2 trial is available during a poster session at the 2023 European Society for Medical Oncology (ESMO) Annual Congress in Madrid:

来自1/2期试验的数据可在马德里2023年欧洲肿瘤内科学会（ESMO）年会的海报会议上获得：

Date: Sunday, October 22, 2023

日期：2023年10月22日星期日

Presentation number: 1803P

演示文稿编号：1803P

Time: 12:00 – 1:00 p.m. CEST / 6:00 – 7:00 a.m. EDT

时间：12:00–1:00下午CEST/6:00–7:00上午EDT

Speaker: Daniel Petrylak, M.D.

发言人：Daniel Petrylak，M.D。

The Company will host a conference call and webcast call at 3:00 p.m. CEST / 9:00 a.m. EDT on October 22 to discuss these data as well as previously undisclosed data from the ongoing Phase 1/2 clinical trial with ARV-766. Participants are invited to listen by going to the Events and Presentation section under the Investor page on the Arvinas website at www.arvinas.com.

该公司将于10月22日下午3:00召开CEST/上午9:00召开电话会议和网络广播电话，讨论这些数据以及之前未公开的ARV-766正在进行的1/2期临床试验数据。邀请参与者通过访问Arvinas网站www.Arvinas.com上投资者页面下的活动和演示部分进行倾听。

A replay of the webcast will be archived on the Arvinas website following the presentation..

演示后，网络广播的重放将存档在Arvinas网站上。。

About bavdegalutamide (ARV-110) and ARV-766

关于巴伐他胺（ARV-110）和ARV-766

Bavdegalutamide (ARV-110) and ARV-766 are investigational orally bioavailable PROTAC® protein degraders designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide and ARV-766 are being developed as potential treatments for men with prostate cancer. Preclinically, both investigational agents have demonstrated activity in models of wild type androgen receptor tumors in addition to tumors with AR mutations or amplification, both common potential mechanisms of resistance to currently available AR-targeted therapies..

Bavdegalutamide（ARV-110）和ARV-766是研究性口服生物可利用的PROTAC®蛋白降解剂，旨在选择性靶向和降解雄激素受体（AR）。Bavdegalutamide和ARV-766正在开发为前列腺癌男性的潜在治疗方法。临床上，除了具有AR突变或扩增的肿瘤外，这两种研究药物均已在野生型雄激素受体肿瘤模型中显示出活性，这两种肿瘤都是对当前可用的AR靶向疗法产生耐药性的常见潜在机制。。

About Arvinas

Arvinas

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.

Arvinas是一家临床阶段生物技术公司，致力于通过发现，开发和商业化降解致病蛋白的疗法来改善患有衰弱和威胁生命的疾病的患者的生活。Arvinas使用其专有的PROTAC®发现引擎平台设计蛋白水解靶向嵌合体或PROTAC靶向蛋白降解物，旨在利用人体自身的天然蛋白质处理系统选择性地有效降解和去除致病蛋白。

In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs: bavdegalutamide and ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

除了针对经过验证和“不可摧毁”的目标的PROTAC蛋白降解物的强大临床前管道外，该公司还有三个研究性临床阶段计划：bavdegalutamide和ARV-766，用于治疗转移性去势抵抗性前列腺癌患者；和vepdegestrant（ARV-471）用于治疗局部晚期或转移性ER+/HER2-乳腺癌患者。

For more information, visit www.arvinas.com..

欲了解更多信息，请访问www.arvinas.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential advantages and therapeutic benefits of Arvinas’ PROTAC® androgen receptor (AR) degraders, bavdegalutamide and ARV-766; the potential for bavdegalutamide and ARV-766 as treatment choices for patients whose tumors harbor AR ligand binding domain mutation; the potential breadth of activity of bavdegalutamide in a late-line setting; whether ARV-766 will be a first- and best-in class treatment for patients with early- and late-line prostate cancer; the addressable patient population for ARV-766, bavdegalutamide and ARV-766 as compared to bavdegalutamide; the timing of progression free survival data for ARV-766; whether ARV-766 will be a superior PROTAC® AR degrader versus bavdegalutamide for both metastatic castration-sensitive prostate cancer and metastatic castration-resistant prostate cancer; and the timing for Arvinas to initiate discussions with regulatory authorities.

本新闻稿包含1995年“私人证券诉讼改革法”含义范围内的前瞻性声明，涉及重大风险和不确定性，包括关于Arvinas雄激素受体（AR）降解物，bavdegalutamide和ARV-766；bavdegalutamide和ARV-766作为肿瘤携带AR配体结合域突变的患者的治疗选择的潜力；bavdegalutamide在晚期的潜在活动范围；对于早期和晚期前列腺癌患者，ARV-766是否将成为一流和一流的治疗方案；ARV-766，bavdegalutamide和ARV-766与bavdegalutamide相比可寻址的患者人群；ARV-766的无进展生存数据的时间；对于转移性去势敏感性前列腺癌和转移性去势抵抗性前列腺癌，ARV-766是否将成为优于PROTAC®AR降解剂与bavdegalutamide的；以及Arvinas开始与监管机构讨论的时机。

All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “predict,” “target,” “potential,” “will,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words..

本新闻稿中包含的除历史事实陈述外的所有陈述，包括有关我们的战略，未来运营，未来财务状况，未来收入，预计成本，前景，计划和管理目标的陈述，均为前瞻性陈述。“预期”，“相信”，“期望”，“打算”，“可能”，“计划”，“预测”，“目标”，“潜力”，“将会”，“应该”，“继续”，类似的表达方式旨在标识前瞻性陈述，尽管并非所有前瞻性陈述都包含这些标识词。。

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct and complete development for ARV-766 and bavdegalutamide; whether we initiate and complete clinical trials for our product candidates and receive results from our clinical trials on our expected timelines or at all; our ability to obtain marketing approval for and commercialize our androgen receptor program product candidates on our current timelines or at all; our ability to maintain, expand and protect our intellectual property portfolio; whether our cash and cash equivalent resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors, and other important factors discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent other reports on file with the Securities and Exchange Commission.

我们实际上可能无法实现我们前瞻性声明中披露的计划，意图或期望，您不应过分依赖我们的前瞻性声明。实际结果或事件可能与我们因各种风险和不确定性而在前瞻性陈述中披露的计划，意图和期望有很大不同，包括但不限于：我们是否能够成功开展和完成开发ARV-766和bavdegalutamide；我们是否为我们的候选产品启动并完成临床试验，并按照我们预期的时间表或根本从我们的临床试验中获得结果；我们能够在我们目前的时间表或根本上获得我们的雄激素受体计划产品候选人的市场批准并将其商业化；我们维护，扩展和保护知识产权组合的能力；我们的现金和现金等价资源是否足以为我们可预见和不可预见的运营费用和资本支出要求提供资金；以及其他重要因素，以及我们在2022年12月31日结束的年度10-K年度报告“风险因素”部分以及随后提交给证券交易委员会的其他报告中讨论的其他重要因素。

The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release..

本新闻稿中包含的前瞻性声明反映了我们对未来事件的当前观点，除适用法律要求外，我们不承担更新任何前瞻性声明的义务。截至本版本发布之日起的任何日期，这些前瞻性声明均不应视为代表我们的观点。。

Contacts

联络

Investors:

投资者：

Jeff Boyle

Jeff Boyle

+1 (347) 247-5089

+1 (347) 247-5089

Jeff.Boyle@arvinas.com

Jeff.Boyle@arvinas.com

Media:

媒体：

Kirsten Owens

Kirsten Owens

+1 (203) 584-0307

+1 (203) 584-0307

Kirsten.Owens@arvinas.com

Kirsten.Owens@arvinas.com