Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced longer-term efficacy and safety results from Arm A1 of the Phase 2 EDGE-Gastric study. These updated data show consistent objective response rate (ORR) and provide mature progression-free survival (PFS) in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma (upper GI cancers).

Gilead Sciences，Inc.（纳斯达克股票代码：GILD）和Arcus Biosciences，Inc.（纽约证券交易所代码：RCUS）今天宣布了第二阶段边缘胃研究A1组的长期疗效和安全性结果。这些更新的数据显示了一致的客观缓解率（ORR），并为局部晚期不可切除或转移性胃，胃食管交界处或食管腺癌（上消化道癌）患者提供了成熟的无进展生存期（PFS）。

The ongoing, multi-arm, global Phase 2 EDGE-Gastric study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in this patient population. These results will be presented today during the American Society of Clinical Oncology (ASCO) Plenary Series: Rapid Abstract Updates session by Yelena Y.

正在进行的多臂全球2期EDGE胃研究正在评估Fc沉默抗TIGIT抗体多马伐那单抗加上抗PD-1单克隆抗体齐贝利马和化疗在该患者人群中的各种组合的安全性和有效性。这些结果将于今天在美国临床肿瘤学会（ASCO）全体会议系列：Yelena Y的快速摘要更新会议上发表。

Janjigian, M.D., Chief, Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center, and a principal investigator for the EDGE-Gastric study (Abstract 433248)..

Janjigian，医学博士，纪念斯隆·凯特琳癌症中心胃肠肿瘤学主任，EDGE胃研究首席研究员（摘要433248）。。

“I am encouraged to see that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival beyond one year, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone,” said Dr. Janjigian. “Notably, nearly 60% of patients in the EDGE-Gastric study achieved progression-free survival at 12 months.

Janjigian博士说：“我很高兴地看到，接受domvanalimab加zimberimab和化疗的患者的中位无进展生存期超过了一年，这超过了单独使用抗PD-1加化疗的历史基准。”。“值得注意的是，EDGE胃研究中近60%的患者在12个月时获得了无进展生存期。

These promising results reinforce our confidence in the ongoing Phase 3 STAR-221 study, which evaluates the same regimen in the same patient population and has the potential to address a high unmet need for people with these cancers.”.

这些有希望的结果增强了我们对正在进行的3期STAR-221研究的信心，该研究评估了同一患者群体中的相同方案，并有可能解决这些癌症患者的高度未满足需求。”。

At data cutoff (DCO, March 12, 2024), safety and efficacy were evaluated in all patients enrolled and treated (n=41). With a median time on treatment of 49.4 weeks (range: 0.4 - 79.4 weeks), the domvanalimab plus zimberelimab and chemotherapy regimen demonstrated sustained improvement across efficacy measures, including in those patients who have low PD-L1 expression..

在数据截止时（DCO，2024年3月12日），对所有入选和治疗的患者（n=41）进行了安全性和有效性评估。治疗的中位时间为49.4周（范围：0.4-79.4周），多马利单抗联合齐贝利单抗和化疗方案在疗效指标上表现出持续改善，包括那些PD-L1表达低的患者。。

Summary of efficacy results:

疗效结果总结：

Endpoint

端点

Overall*

总体*

PD-L1-high

PD-L1-高

PD-L1-low

PD-L1-低

n=41

n=41

(TAP ≥5%)

（抽头≥5%）

(TAP <5%)

（抽头<5%）

n=16

n=16

n=24

n=24

Progression-Free Survival (PFS)

无进展生存期（PFS）

Median in Months (95% CI)

月份中位数（95%置信区间）

12.9 mos (9.8, 13.8)

12.9个月（9.8、13.8）

13.8 mos (11.3, NE)

13.8个月（11.3，东北）

11.3 mos (5.5, 13.8)

11.3个月（5.5、13.8）

12-month PFS Rate (95% CI)

12个月PFS率（95%置信区间）

57.6% (41.7,73.5)

57.6% (41.7,73.5)

68.8% (46.0, 91.5)

68.8% (46.0, 91.5)

46.8% (24.7, 68.9)

46.8% (24.7, 68.9)

Objective Response Rate

客观回应率

(ORR)

（ORR）

per RECIST v1.1

按照RECIST v1.1

Confirmed ORR (95% CI)

已确认ORR（95%CI）

58.5% (42.1, 73.7)

58.5% (42.1, 73.7)

68.8% (41.3, 89.0)

68.8% (41.3, 89.0)

50.0% (29.1, 70.9)

50.0% (29.1, 70.9)

Complete Response

完整响应

3 (7.3%)

3 (7.3%)

1 (6.3%)

1 (6.3%)

1 (4.2%)

1 (4.2%)

Partial Response

部分响应

21 (51.2%)

21 (51.2%)

10 (62.5%)

10 (62.5%)

11 (45.8%)

11 (45.8%)

Stable Disease

病情稳定

14 (34.1%)

14 (34.1%)

5 (31.3%)

5 (31.3%)

9 (37.5%)

9 (37.5%)

Progressive Disease Confirmed

确认进行性疾病

2 (4.9%)

2 (4.9%)

0

0

2 (8.3%)

2 (8.3%)

Not Evaluable**

不可评估**

1 (2.4%)

1 (2.4%)

0

0

1 (4.2%)

1 (4.2%)

Median Duration of Response

响应的中位持续时间

(DOR) in Months

（DOR）（以月为单位）

12.4 mos (9.9, NE)

12.4个月（9.9，东北）

NE (11.5, NE)

NE（11.5，NE）

10.2 mos (4.0, 12.4)

10.2个月（4.0、12.4）

*One subject with no tissue available for central PD-L1 testing. From local lab results, the subject is PD-L1 low via 22-C3 assay. This subject achieved confirmed complete response.

*一名没有组织可用于中央PD-L1测试的受试者。从当地实验室结果来看，通过22-C3测定，受试者的PD-L1水平较低。该受试者获得了确认的完全回应。

** One subject has no post baseline scans.

**一名受试者没有基线后扫描。

CI: confidence interval

CI：置信区间

NE: not evaluable

NE：不可评估

TAP: tumor area positivity

TAP：肿瘤区域阳性

No unexpected safety signals were observed at the time of DCO. The domvanalimab plus zimberelimab and chemotherapy regimen was generally well tolerated and showed an overall safety profile consistent with the known safety profiles of each individual molecule to date. Infusion-related reactions were observed in 19.5% of the total subjects, and the majority were related to chemotherapy..

DCO时未观察到意外的安全信号。domvanalimab加zimberilimab和化疗方案通常耐受性良好，并且显示出与迄今为止每个单独分子的已知安全性一致的总体安全性。在总受试者中有19.5%观察到与输注相关的反应，大多数与化疗有关。。

The updated data from Arm A1 of the Phase 2 EDGE-Gastric study support the ongoing Phase 3 STAR-221 study, in unresectable or metastatic upper GI cancers, which is expected to complete enrollment mid-year 2024.

第二阶段边缘胃癌研究A1组的最新数据支持正在进行的第三阶段STAR-221研究，该研究针对不可切除或转移性上消化道癌症，预计将于2024年年中完成登记。

Domvanalimab 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 gastrointestinal cancers have not been established.

Domvanalimab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，其治疗胃肠道癌症的安全性和有效性尚未确定。

About the EDGE-Gastric Study

关于边缘胃研究

The ongoing, multi-arm, multi-cohort global Phase 2 EDGE-Gastric trial (NCT05329766) is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab and the anti-PD-1 monoclonal antibody zimberelimab in patients with locally advanced unresectable or metastatic gastric (G), gastroesophageal junction (GEJ) or esophageal (E) adenocarcinoma.

正在进行的多组多队列全球2期EDGE胃试验（NCT05329766）正在评估Fc沉默抗TIGIT抗体多姆瓦那利马和抗PD-1单克隆抗体齐姆贝利马的各种组合在局部晚期不可切除或转移性胃（G），胃食管交界处（GEJ）或食管（E）腺癌患者中的安全性和有效性。

Patients in Arm A1, with previously untreated G/GEJ/E adenocarcinoma, received 1600 mg of domvanalimab intravenously (IV) every four weeks (Q4W) plus 480 mg of zimberelimab IV Q4W + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2 IV, fluorouracil 400 mg/m2 IV bolus + 2400 mg/m2 continuous 46-48-hour IV infusion) every two weeks..

A1组患者，先前未经治疗的G/GEJ/E腺癌患者，每四周（Q4W）静脉注射（IV）1600 mg多马伐那单抗，加上480 mg zimberilimab IV Q4W+FOLFOX（奥沙利铂85 mg/m2 IV，亚叶酸钙400 mg/m2 IV，氟尿嘧啶400 mg/m2 IV推注+2400 mg/m2连续46-48小时IV输注）。。

About Domvanalimab

关于Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response.

Domvanalimab是第一种也是临床上最先进的Fc沉默研究性单克隆抗体，专门设计具有Fc沉默特性，可阻断并结合具有Ig和ITIM结构域（TIGIT）的T细胞免疫受体，TIGIT是免疫细胞上的检查点受体，可作为抗癌免疫反应的刹车。

By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity..

通过与具有Fc沉默特性的TIGIT结合，domvanalimab被认为通过释放免疫激活途径并激活免疫细胞来攻击和杀死癌细胞而不消耗对避免免疫相关毒性很重要的外周调节性T细胞。。

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab, as well as other investigational cancer immunotherapies and A2a/A2b adenosine receptor antagonist etrumadenant, in multiple ongoing and planned early and late-stage clinical studies in various tumor types..

TIGIT和程序性细胞死亡蛋白-1（PD-1）的联合抑制被认为可显着增强免疫细胞活化，因为这些检查点受体在抗肿瘤活性中起着独特的互补作用。Domvanalimab正在与抗PD-1单克隆抗体（包括zimberimab）以及其他研究性癌症免疫疗法和A2a/A2b腺苷受体拮抗剂etrumadenant联合进行多种正在进行和计划中的各种肿瘤类型的早期和晚期临床研究。。

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在美国不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。。