FOSTER CITY, Calif. & HAYWARD, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced new data from Cohort B of ARC-9, a Phase 1b/2 study evaluating the safety and efficacy of etrumadenant, a dual A2a/b adenosine receptor antagonist, plus anti-PD-1 monoclonal antibody zimberelimab, FOLFOX chemotherapy and bevacizumab (EZFB) in third-line metastatic colorectal cancer (mCRC).

加利福尼亚州福斯特城和加利福尼亚州海沃德——（商业新闻短讯）——吉利德科学公司（纳斯达克股票代码：GILD）和Arcus生物科学公司（纽约证券交易所代码：RCUS）今天宣布了ARC-9队列B的新数据，这是一项1b/2期研究，评估了双重A2a/B腺苷受体拮抗剂依曲马地南（etrumadenant）加上抗PD-1单克隆抗体zimberlimab，FOLFOX化疗和贝伐单抗（EZFB）在三线转移性结直肠癌（mCRC）中的安全性和有效性。

These results will be presented today during an oral session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting by Zev A. Wainberg, M.D., MSc, Co-Director of the GI Oncology Program at University of California Los Angeles and a principal investigator of the ARC-9 trial (Abstract 3508)..

这些结果将于今天在2024年美国临床肿瘤学会（ASCO）年会上由加利福尼亚大学洛杉矶分校胃肠道肿瘤学项目联合主任兼ARC-9试验首席研究员Zev A.Wainberg医学博士（理学硕士）在口头会议上介绍（摘要3508）。。

“ARC-9 is the first randomized Phase 2 study to show that combining an adenosine receptor blocker with anti-PD-1, anti-VEGF and chemotherapy can meaningfully improve clinical outcomes for people with metastatic colorectal cancer who have progressed on at least two prior therapies,” said Dr. Wainberg.

Wainberg博士说：“ARC-9是第一项随机2期研究，表明腺苷受体阻滞剂与抗PD-1，抗VEGF和化疗联合使用可以显着改善转移性结直肠癌患者的临床预后，这些患者至少在两种治疗方法上取得了进展。”。

“19.7 months is the longest median overall survival reported in third-line mCRC and warrants further investigation of an etrumadenant-based regimen as a potential treatment option in CRC1.”.

“19.7个月是三线mCRC报告的最长中位总生存期，值得进一步研究以依曲美坦为基础的方案作为CRC1的潜在治疗选择。”。

Cohort B of ARC-9 randomized 112 patients with comparable baseline characteristics between two arms: EZFB or regorafenib. At the time of data cut-off (November 13, 2023) median follow-up was 20.4 months. Patient baseline characteristics were similar to those of third-line patients who have progressed on oxaliplatin- and irinotecan-based regimens in mCRC1.

ARC-9队列B将112名患者随机分为两组：EZFB或瑞格非尼。在数据截止时（2023年11月13日），中位随访时间为20.4个月。患者基线特征与在mCRC1中以奥沙利铂和伊立替康为基础的方案进展的三线患者相似。

OS and PFS were consistently longer in the EZFB arm versus regorafenib, in all sub-groups analyzed, including in patients with liver metastases..

在所有分析的亚组中，包括肝转移患者，EZFB组的OS和PFS始终比瑞格非尼组更长。。

Summary of efficacy results:

疗效结果总结：

EZFB*

EZFB*

n=75

n=75

regorafenib

瑞戈非尼

n=37

n=37

Median OS, months

中位OS，月

19.7

19.7

9.5

9.5

Hazard Ratio (95% CI), P-value

危险比（95%置信区间），P值

HR 0.37

人力资源0.37

95% CI 0.22-0.63

95%置信区间0.22-0.63

p=0.0003

p=0.0003

Median PFS, months

中位PFS，月

6.2

6.2

2.1

2.1

Hazard Ratio (95% CI), P-value

危险比（95%置信区间），P值

HR 0.27

人力资源0.27

95% CI 0.17-0.43

95%置信区间0.17-0.43

p<0.0001

p<0.0001

Confirmed ORR

确认ORR

13 (17.3%)

13 (17.3%)

1 (2.7%)

1 (2.7%)

Median DOR, months

DOR中位数，月

11.5

11.5

NE

东北

CI: confidence interval

CI：置信区间

OS: overall survival

OS：总体生存

PFS: progression-free survival

PFS：无进展生存期

ORR: objective response rate

ORR：客观回应率

DOR: duration of response

DOR：响应持续时间

NE: not evaluable; only one patient with response

NE：不可评估；只有一名患者有反应

*bevacizumab was included for all patients in whom it is not contraindicated

*贝伐单抗包括在所有非禁忌的患者中

The EZFB regimen had a safety profile consistent with the known safety profiles of each individual molecule to date, without unexpected toxicities. A higher percentage of patients treated with regorafenib (17%) had a treatment emergent adverse event (TEAE) leading to discontinuation of all study drugs than those treated with EZFB (5%).

EZFB方案的安全性与迄今为止每个分子的已知安全性一致，没有意外的毒性。接受瑞格非尼治疗的患者（17%）发生治疗紧急不良事件（TEAE）的比例高于接受EZFB治疗的患者（5%）。

A lower percentage of patients experienced Grade ≥3 TEAEs attributed to etrumadenant or zimberelimab versus regorafenib (23.0% vs 25.7%)..

与瑞格非尼相比，因依曲美丹特或zimberelimab而经历≥3级TEAE的患者比例较低（23.0%比25.7%）。。

Etrumadenant and zimberelimab are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of colorectal cancer have not been established.

Etrumadenant和zimberelimab是研究分子。Gilead和Arcus均未获得任何监管机构对这些分子的任何使用批准，其治疗结直肠癌的安全性和有效性尚未确定。

About the ARC-9 Study

关于ARC-9研究

ARC-9 (NCT04660812) is a Phase 1b/2 trial evaluating the safety and efficacy of etrumadenant (E), a dual A2a/A2b adenosine receptor antagonist, plus anti-PD-1 antibody zimberelimab (Z), FOLFOX and bevacizumab (if not contraindicated) in three cohorts of patients with mCRC. The primary endpoint is PFS per RECIST 1.1, and OS is a key secondary endpoint.

ARC-9（NCT04660812）是一项1b/2期临床试验，评估etrumadent（E）（一种双重A2a/A2b腺苷受体拮抗剂）加上抗PD-1抗体zimberelimab（Z），FOLFOX和贝伐单抗（如果不是禁忌）在三组mCRC患者中的安全性和有效性。根据RECIST 1.1，主要终点是PFS，OS是关键的次要终点。

Cohort B enrolled patients who previously progressed on both oxaliplatin- and irinotecan-containing chemotherapy in combination with anti-VEGF (R) therapy or anti-EGFR. Patients were randomized 2:1 to the etrumadenant plus zimberelimab regimen: E (150 mg orally [PO] once daily [QD]) + Z (240 mg intravenous [IV] once every 2 weeks [Q2W]) + mFOLFOX-6 + bevacizumab (5 mg/kg IV Q2W), or regorafenib (administered at a starting dose of 80 mg/day for the first week, followed by a dose escalation of 40 mg every week to 120 mg/day for the second week and 160 mg/day for the third week during Cycle 1 followed by 160 mg/day on Days 1-21 of each subsequent 28-day cycle).

队列B纳入了先前在含奥沙利铂和伊立替康的化疗联合抗VEGF（R）治疗或抗EGFR治疗中取得进展的患者。患者以2:1的比例随机分为etrumadenant加zimberelimab方案：E（150 mg口服[口服]每日一次[QD]）+Z（240 mg静脉注射[静脉注射]每2周一次[Q2W]）+mFOLFOX-6+贝伐单抗（5 mg/kg静脉注射Q2W）或瑞格非尼（第一周起始剂量为80 mg/天，随后在第二周每周剂量递增40 mg至120 mg/天，第三周剂量递增160 mg/天，第1周，随后在随后的每个28天周期的第1-21天每天160 mg）。

Patients who progressed on regorafenib were allowed to crossover to the etrumadenant plus zimberelimab regimen..

雷戈拉非尼治疗进展的患者被允许交叉使用依曲美丹加齐贝利单抗方案。。

ARC-9 is a multi-cohort study in mCRC including Cohort A, which enrolled patients who previously progressed on FOLFOX/FOLFIRI in combination with anti-VEGF(R) or anti-EGFR. Patients were randomized 2:1 to the etrumadenant plus zimberelimab regimen, or FOLFOX-6 + bevacizumab. Data from Cohort A will be presented when they are mature..

ARC-9是mCRC的一项多队列研究，包括队列a，该队列招募了先前在FOLFOX/FOLFIRI联合抗VEGF（R）或抗EGFR治疗中进展的患者。将患者以2:1的比例随机分配到依曲马丹加齐姆贝利单抗方案或FOLFOX-6+贝伐单抗。队列A的数据将在成熟时提供。。

About Etrumadenant

关于Etrumadenant

Etrumadenant is an investigational small molecule, selective dual antagonist of the A2a and A2b receptors designed to prevent adenosine-mediated immunosuppression. Adenosine elicits its immunosuppressive effects within the tumor microenvironment by binding and activating adenosine-specific receptors expressed on the surface of tumor-infiltrating immune cells, which can help cancer cells evade host antitumor immunity.

Etrumadenant是一种研究性小分子选择性A2a和A2b受体双重拮抗剂，旨在预防腺苷介导的免疫抑制。腺苷通过结合和激活肿瘤浸润性免疫细胞表面表达的腺苷特异性受体，在肿瘤微环境中引发其免疫抑制作用，这可以帮助癌细胞逃避宿主的抗肿瘤免疫。

Once etrumadenant binds to the A2a and A2b receptors and blocks the immunosuppressive effects of adenosine, activation of antitumor immune cells may be restored, which could result in tumor cell death..

一旦etrumadenant与A2a和A2b受体结合并阻断腺苷的免疫抑制作用，抗肿瘤免疫细胞的激活可能会恢复，这可能导致肿瘤细胞死亡。。

Etrumadenant is being evaluated in combination with other cancer immunotherapies, including the investigational Fc-silent anti-TIGIT monoclonal antibody domvanalimab and anti-PD-1 monoclonal antibody zimberelimab, in certain types of non-small cell lung and colorectal cancers.

Etrumadenant正在与其他癌症免疫疗法相结合进行评估，包括研究性Fc沉默抗TIGIT单克隆抗体domvanalimab和抗PD-1单克隆抗体zimberilimab，用于某些类型的非小细胞肺癌和结直肠癌。

About Zimberelimab

关于Cimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Zimberelimab是一种抗程序性细胞死亡蛋白-1（PD-1）单克隆抗体，可结合PD-1，目的是恢复T细胞的抗肿瘤活性。Zimberelimab在各种肿瘤类型中表现出高亲和力，选择性和效力。

Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing and planned early and late-stage clinical studies in combination with other immunotherapies, including investigational Fc-silent anti-TIGIT monoclonal antibody domvanalimab and A2a/A2b adenosine receptor antagonist etrumadenant..

Zimberelimab正在美国和全球范围内进行评估，作为基础性抗PD-1治疗选择，在多项正在进行和计划的早期和晚期临床研究中，与其他免疫疗法相结合，包括研究性Fc沉默抗TIGIT单克隆抗体domvanalimab和A2a/A2b腺苷受体拮抗剂etrumadenant。。

Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin's lymphoma. Zimberelimab is not approved for any use in the U.S.

拥有zimberelimab在大中华区商业化权利的广州格洛里亚生物科学有限公司已获得zimberelimab治疗复发或转移性宫颈癌以及复发或难治性经典霍奇金淋巴瘤的批准。Zimberelimab在美国未被批准用于任何用途。

or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead..

或中国以外的其他地区。Gloria独立于Arcus和Gilead进行开发和商业化活动。。

About Arcus Biosciences

关于Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer.

Arcus Biosciences是一家临床阶段的全球生物制药公司，为癌症患者开发分化分子和联合药物。与世界各地的行业合作者、患者和医生合作，Arcus正在加速开发一流或一流的药物，以对抗特征明确的生物靶标和途径，并研究新颖的生物学驱动的组合，这些组合有可能帮助癌症患者活得更长。

Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com..

该公司成立于2015年，加快了多种研究药物进入临床研究的发展，包括针对TIGIT，PD-1，腺苷轴（CD73和双A2a/A2b受体），HIF-2a，CD39和AXL的新组合方法。有关Arcus Biosciences临床和临床前项目的更多信息，请访问www.arcusbio.com。。

About Gilead Sciences

关于吉利德科学

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer.

吉利德科学公司（Gilead Sciences，Inc.）是一家生物制药公司，三十多年来一直致力于医学领域的突破，目标是为所有人创造一个更健康的世界。该公司致力于推进创新药物，以预防和治疗威胁生命的疾病，包括艾滋病毒、病毒性肝炎、新型冠状病毒肺炎和癌症。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California..

吉利德在全球35多个国家运营，总部位于加利福尼亚州福斯特城。。

Arcus Forward-Looking Statements

Arcus前瞻性声明

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements in Dr.

本新闻稿包含前瞻性声明。本文所包含的关于未来事件或结果的所有陈述均为前瞻性陈述，反映了管理层根据1995年《私人证券诉讼改革法案》的安全港条款所做出的当前信念和期望，包括但不限于Dr。

Wainberg quote and statements regarding: whether data and results from the ARC-9 study validate our pipeline or support further development of etrumadenant and/or zimberelimab. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.

Wainberg引用和声明：ARC-9研究的数据和结果是否验证了我们的管道或支持etrumadenant和/或zimberelimab的进一步开发。所有前瞻性陈述都涉及已知和未知的风险和不确定性以及其他重要因素，这些因素可能导致Arcus的实际结果、绩效或成就与前瞻性陈述中明示或暗示的结果、绩效或成就存在重大差异。

Factors that could cause or contribute to such differences include, but are not limited to risks associated with: interim data changing as patient enrollment continues and more patient data becomes available; interim data not being replicated in future studies evaluating the same investigational molecules or regimen; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products; Arcus’s dependence on the collaboration with Gilead for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities with our strategic partners or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials.

可能导致或促成这种差异的因素包括但不限于与以下相关的风险：随着患者登记的继续和更多患者数据的可用，临时数据会发生变化；在评估相同研究分子或方案的未来研究中未复制临时数据；Arcus研究产品中意外出现不良事件或其他不良副作用；Arcus依靠与吉利德的合作成功开发和商业化其选择性分子；与我们的战略合作伙伴或扩大的临床计划管理合作活动相关的困难；Arcus项目竞争格局的变化；以及与药品开发和临床试验相关的固有不确定性。

Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most re.

Arcus面临的风险和不确定性在Arcus的most re的“风险因素”部分中有更全面的描述。

Gilead Forward-Looking Statements

吉利德前瞻性声明

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving etrumadenant and zimberelimab (such as the ARC-9 study); uncertainties relating to regulatory applications and related filing and approval timelines, and the risk that any such approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of etrumadenant and zimberelimab for indications that are currently under evaluation and, as a result, these programs may never be successfully commercialized for such indications; the risk that Gilead may not realize the potential benefits of its collaboration with Arcus or its other investments in oncology; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead’s revenues and earnings; and any assumptions underlying any of the foregoing.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的前瞻性声明，这些声明受到风险、不确定性和其他因素的影响，包括吉利德在目前预期的时间表内或根本不具备启动、进展或完成临床试验的能力，以及正在进行的或其他临床试验（包括涉及etrumadenant和zimberelimab的临床试验（如ARC-9研究））产生不利结果的可能性；与监管申请和相关备案和批准时间表有关的不确定性，以及任何此类批准（如果获得批准）可能受到重大使用限制的风险；吉利德可能会做出战略决定，停止开发etrumadenant和zimberelimab用于目前正在评估的适应症，因此这些计划可能永远无法成功商业化用于此类适应症；吉利德可能无法实现与Arcus合作或其他肿瘤学投资的潜在益处；与合作有关的困难或意外费用以及对吉利德收入和收益的潜在影响；以及基于上述任何一项的任何假设。

These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

这些和其他风险、不确定性和其他因素在吉利德提交给美国证券交易委员会的截至2024年3月31日的季度10-Q表季度报告中有详细描述。这些风险、不确定性和其他因素可能导致实际结果与前瞻性声明中提及的结果存在重大差异。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward.

除历史事实陈述外的所有陈述均为可被视为前瞻性陈述的陈述。读者应注意，任何此类转发。

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

Gilead和Gilead徽标是Gilead Sciences，Inc.或其关联公司的商标。

Arcus name and logo are trademarks of Arcus Biosciences, Inc.

Arcus名称和徽标是Arcus Biosciences，Inc.的商标。

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

有关吉利德的更多信息，请访问公司网站www.Gilead.com，在X/Twitter（@Gilead Sciences）和LinkedIn（@Gilead Sciences）上关注吉利德。

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1 Prager GW, et al. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023;388(18):1657-1667. doi: 10.1056/NEJMoa2214963. PMID: 37133585.

1 Prager GW等人。三氟尿苷替吡拉西和贝伐单抗治疗难治性转移性结直肠癌。英格兰医学杂志2023；388（18）：1657-1667。内政部：10.1056/NEJMoa2214963。PMID:37133585。