Exelixis在2025年ASCO会议上宣布了STELLAR-002一期b/二期试验的鼓舞人心的结果，该试验评估了Zanzalintinib与免疫检查点抑制剂联合治疗晚期肾癌的效果-动脉网

Exelixis Announces Encouraging Results from Phase 1b/2 STELLAR-002 Trial Evaluating Zanzalintinib in Combination with Immune Checkpoint Inhibitors in Advanced Kidney Cancer at ASCO 2025

伊克力西斯等信源发布 2025-05-22 05:49



可切换为仅中文







– Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90% –

– Zanzalintinib联合纳武利尤单抗的客观缓解率为63%，疾病控制率为90% –

– Additional results from dose-finding cohorts will also be presented –

– 剂量探索队列的更多结果也将会被展示 –

ALAMEDA, Calif.

阿拉米达，加利福尼亚州

--(BUSINESS WIRE)--May 22, 2025--

--（商业资讯）--2025年5月22日--

Exelixis, Inc.

Exelixis公司

(Nasdaq: EXEL) today announced results from an expansion cohort of the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo

(Nasdaq: EXEL) 今天宣布了 1b/2 期 STELLAR-002 试验扩展队列的结果，该试验评估了 zanzalintinib 与 nivolumab（Opdivo）的联合使用。

) or a fixed-dose combination of nivolumab and relatlimab (Opdualag™) in patients with previously untreated advanced clear cell renal cell carcinoma (RCC). These findings, as well as data from multiple dose-escalation cohorts from STELLAR-002, will be presented at the 2025

）或固定剂量组合的尼伏鲁单抗和雷拉替单抗（Opdualag™）用于既往未接受过治疗的晚期透明细胞肾细胞癌（RCC）患者。这些发现以及来自STELLAR-002的多个剂量递增队列的数据将于2025年呈现。

American Society of Clinical Oncology

美国临床肿瘤学会

(ASCO) Annual Meeting.

（ASCO）年会。

“We are pleased to present these preliminary findings from the phase 1b/2 STELLAR-002 study, including early signs of promising activity for zanzalintinib in combination with immune checkpoint inhibitors,” said

“我们很高兴公布来自1b/2期STELLAR-002研究的这些初步结果，其中包括zanzalintinib与免疫检查点抑制剂联合使用的早期有希望的活性迹象，”

Amy Peterson

艾米·彼得森

, M.D., Executive Vice President,

医学博士，执行副总裁，

Product Development & Medical Affairs

产品开发与医学事务

, and Chief Medical Officer,

，以及首席医疗官，

Exelixis

埃克塞利西斯

. “Data emerging from this ongoing study are important to help inform further evaluation of zanzalintinib-based regimens in advanced solid tumors, including renal cell carcinoma.”

“这项正在进行的研究中出现的数据对于帮助进一步评估基于赞扎利替尼的方案在晚期实体瘤（包括肾细胞癌）中的应用非常重要。”

Abstract 4515: Zanzalintinib + Nivolumab ± Relatlimab in Patients with Previously Untreated Clear Cell Renal Cell Carcinoma: Results from an Expansion Cohort of the Phase 1b STELLAR-002 Study

摘要 4515：Zanzalintinib + Nivolumab ± Relatlimab 治疗既往未接受过治疗的透明细胞肾细胞癌患者：来自 1b 期 STELLAR-002 研究扩展队列的结果

Lead Author:

主要作者：

Jad Chahoud

, M.D., M.P.H.,

，医学博士，公共卫生硕士，

Moffitt Cancer Center

莫菲特癌症中心

，

Tampa, Fla.

佛罗里达州坦帕市

, USA

，美国

Session Title: Genitourinary Cancer—Kidney and Bladder

会议标题：泌尿生殖系统癌症——肾与膀胱

Saturday, May 31

5月31日，星期六

，

1:15-2:45 p.m. CDT

下午1:15-2:45，中部夏令时间

This expansion cohort of STELLAR-002 included patients with advanced clear cell RCC who received zanzalintinib in combination with either nivolumab (n=40) or fixed-dose nivolumab and relatlimab (n=40) in two non-randomized treatment arms. Patients had unresectable advanced or metastatic disease for which they received no prior systemic therapy.

STELLAR-002 的这一扩展队列包括晚期透明细胞肾细胞癌患者，他们接受了赞扎利替尼联合纳武利尤单抗（n=40）或固定剂量纳武利尤单抗和瑞拉利单抗（n=40）的治疗，分为两个非随机治疗组。患者患有无法切除的晚期或转移性疾病，且未接受过先前的系统治疗。

Intermediate- or poor-risk disease, per the .

根据，中危或差危疾病。

International Metastatic RCC Database Consortium

国际转移性肾细胞癌数据库联盟

, accounted for 75% of patients receiving zanzalintinib in combination with nivolumab and 70% of patients receiving zanzalintinib in combination with fixed-dose nivolumab and relatlimab.

，占接受赞扎利替尼联合纳武利尤单抗治疗患者的75%，以及接受赞扎利替尼联合固定剂量纳武利尤单抗和瑞拉利单抗治疗患者的70%。

At a median follow-up of 20.1 months for those receiving zanzalintinib in combination with nivolumab and 15.9 months for those receiving zanzalintinib in combination with fixed-dose nivolumab and relatlimab, the objective response rates were 63% (95% confidence interval [CI]: 46-77%) and 40% (95% CI: 25-57%), respectively.

在中位随访20.1个月的接受赞扎利替尼联合纳武利尤单抗治疗的患者和中位随访15.9个月的接受赞扎利替尼联合固定剂量纳武利尤单抗和雷拉利单抗治疗的患者中，客观缓解率分别为63%（95%置信区间[CI]：46-77%）和40%（95% CI：25-57%）。

Disease control rates were 90% (95% CI: 76-97%) for both arms. The 12-month duration of response was 73.4% (95% CI: 50.0-87.1%) and 74.1% (95% CI: 39.1-90.9%), respectively. Median progression-free survival was 18.5 months (95% CI: 9.5 months-not estimable [NE]) and 13.0 months (95% CI: 7.4 months-NE), respectively..

两组的疾病控制率均为90%（95%置信区间：76-97%）。12个月的反应持续率分别为73.4%（95%置信区间：50.0-87.1%）和74.1%（95%置信区间：39.1-90.9%）。中位无进展生存期分别为18.5个月（95%置信区间：9.5个月-无法估计[NE]）和13.0个月（95%置信区间：7.4个月-NE）。

“While significant progress has been made in advanced clear cell renal cell carcinoma, many patients still experience disease progression, and more effective therapies earlier in the treatment landscape are needed,” said

“虽然在晚期透明细胞肾细胞癌方面取得了显著进展，但许多患者仍然经历疾病进展，因此在治疗早期需要更有效的疗法，”

Jad Chahoud

, M.D., M.P.H., Associate Member,

医学博士、公共卫生硕士、副研究员，

Department of Genitourinary Oncology and Medical

泌尿生殖肿瘤学和内科部

Director of the Inpatient/Outpatient (IPOP) service at

住院/门诊 (IPOP) 服务主任

Moffitt Cancer Center

莫菲特癌症中心

在

Tampa, Fla.

佛罗里达州坦帕市

, who is presenting the findings. “The high rate of durable responses and long progression-free survival observed for zanzalintinib in combination with nivolumab are encouraging and support further evaluation of this regimen.”

“赞扎利替尼与纳武利尤单抗联合使用时观察到的高持久应答率和长无进展生存期令人鼓舞，并支持对该方案进行进一步评估。”

Treatment-emergent adverse events (TEAEs) of any grade were reported in all patients. Grade 3/4 TEAEs occurring in at least four patients receiving zanzalintinib in combination with nivolumab included hypertension (n=13), diarrhea (n=6), aspartate aminotransferase increase (n=5), alanine aminotransferase increase (n=5) and palmar-plantar erythrodysesthesia (n=4).

所有患者均报告了任意级别的治疗中出现的不良事件（TEAEs）。在接受赞扎利替尼联合纳武利尤单抗治疗的患者中，至少有四名患者发生了3/4级TEAEs，其中包括高血压（n=13）、腹泻（n=6）、天门冬氨酸氨基转移酶升高（n=5）、丙氨酸氨基转移酶升高（n=5）以及掌跖红斑感觉异常（n=4）。

Grade 3/4 TEAEs occurring in at least four patients receiving zanzalintinib in combination with fixed-dose nivolumab and relatlimab included hypertension (n=6), rash (n=6), lipase increase (n=4) and pulmonary embolism (n=4). There were two grade 5 TEAEs in each arm; none were considered related to study treatment.

接受赞扎利替尼联合固定剂量纳武利尤单抗和雷拉利单抗治疗的患者中，至少有四名患者出现了3/4级治疗期间不良事件（TEAEs），包括高血压（n=6）、皮疹（n=6）、脂肪酶升高（n=4）和肺栓塞（n=4）。每组均有两例5级TEAEs；均被认为与研究治疗无关。

Three patients (8%) in the zanzalintinib in combination with nivolumab arm and eight patients (20%) in the zanzalintinib in combination with fixed-dose nivolumab and relatlimab arm discontinued all study drugs for treatment-related AEs as assessed by investigator..

三名患者（8%）在zanidatinib联合nivolumab组和八名患者（20%）在zanidatinib联合固定剂量nivolumab和relatlimab组因研究者评估的治疗相关不良事件停止了所有研究药物。

Abstract 3101: Zanzalintinib + Nivolumab ± Relatlimab in Patients with Advanced Solid Tumors: Results from Two Dose-Escalation Cohorts of the Phase 1b STELLAR 002 Study

摘要3101：Zanzalintinib + Nivolumab ± Relatlimab 治疗晚期实体瘤患者：来自1b期STELLAR 002研究的两个剂量递增队列的结果

Lead Author:

主要作者：

Benjamin Garmezy

本杰明·加梅基

, M.D.,

，医学博士，

Sarah Cannon Research Institute

莎拉·坎农研究所

，

Nashville, Tenn.

纳什维尔，田纳西州

, USA

，美国

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

会议标题：发展治疗学——分子靶向药物与肿瘤生物学

Monday, June 2

6月2日，星期一

，

1:30-4:30 p.m. CDT

下午1:30-4:30，中部夏令时间

This analysis of STELLAR-002 included multiple cohorts of patients with advanced solid tumors who received zanzalintinib 100 mg in combination with nivolumab (n=19); zanzalintinib 60 mg in combination with fixed-dose nivolumab and relatlimab (n=24); or zanzalintinib 100 mg in combination with fixed-dose nivolumab and relatlimab (n=25).

STELLAR-002 分析包括多个晚期实体瘤患者队列，这些患者接受了 100 mg 的赞扎林替尼联合纳武利尤单抗（n=19）；60 mg 的赞扎林替尼联合固定剂量的纳武利尤单抗和瑞拉利单抗（n=24）；或 100 mg 的赞扎林替尼联合固定剂量的纳武利尤单抗和瑞拉利单抗（n=25）。

The most common cancer types for those receiving zanzalintinib in combination with nivolumab were colorectal and prostate cancers, followed by lung cancer and RCC. The most common tumor types in the zanzalintinib in combination with fixed-dose nivolumab and relatlimab cohorts were RCC, followed by prostate cancer, melanoma and colorectal cancer..

接受赞扎利替尼联合纳武利尤单抗治疗的患者最常见的癌症类型是结直肠癌和前列腺癌，其次是肺癌和肾细胞癌（RCC）。在赞扎利替尼联合固定剂量纳武利尤单抗和瑞拉利单抗队列中，最常见的肿瘤类型是肾细胞癌（RCC），其次是前列腺癌、黑色素瘤和结直肠癌。

The findings showed that the toxicity profile of these combinations was manageable and consistent with each monotherapy agent. Preliminary safety, efficacy and pharmacokinetic results supported selection of the 100 mg dose for zanzalintinib for the ongoing expansion cohorts.

研究结果显示，这些组合的毒性特征是可管理的，并且与每种单药治疗药物一致。初步的安全性、有效性和药代动力学结果支持为正在进行的扩展队列选择100毫克剂量的赞扎林替尼。

About STELLAR-002

关于STELLAR-002

STELLAR-002 (NCT05176483) is a global, open-label phase 1b/2 study of zanzalintinib as a single agent or in combination with nivolumab, fixed-dose nivolumab and relatlimab or nivolumab and ipilimumab in advanced solid tumors. The objective of the study is to evaluate the safety, tolerability and efficacy of zanzalintinib alone and in these combinations.

STELLAR-002（NCT05176483）是一项全球性、开放标签的1b/2期研究，评估单药使用zanzalintinib或与nivolumab、固定剂量nivolumab和relatlimab、或nivolumab和ipilimumab联合治疗晚期实体瘤的效果。该研究的目的是评估zanzalintinib单药及其在这些组合中的安全性、耐受性和疗效。

The trial is divided into two parts: a dose-escalation stage and an expansion cohort stage. Expansion cohorts include patients with clear cell RCC, non-clear cell RCC, castration-resistant prostate cancer, urothelial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer and head and neck squamous cell carcinoma.

试验分为两部分：剂量递增阶段和扩展队列阶段。扩展队列包括透明细胞肾细胞癌、非透明细胞肾细胞癌、去势抵抗性前列腺癌、尿路上皮癌、肝细胞癌、非小细胞肺癌、结直肠癌以及头颈部鳞状细胞癌患者。

。

Exelixis

埃克塞利西斯

is sponsoring STELLAR-002, and

正在赞助STELLAR-002，而且

Bristol Myers Squibb

百时美施贵宝

is providing nivolumab, ipilimumab and a fixed-dose combination of nivolumab and relatlimab for use in the trial. More information about the trial is available at

提供纳武利尤单抗、伊匹木单抗以及纳武利尤单抗和瑞拉利单抗的固定剂量组合用于试验。有关该试验的更多信息可在此处获取：

ClinicalTrials.gov

临床试验.gov

。

About Zanzalintinib

关于Zanzalintinib

Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors.

Zanzalintinib 是一种第三代口服酪氨酸激酶抑制剂，可抑制与癌症生长和扩散相关的受体酪氨酸激酶的活性，包括VEGF受体、MET、AXL和MER。这些受体酪氨酸激酶不仅参与正常的细胞功能，还参与诸如致癌作用、转移、肿瘤血管生成以及对多种疗法（包括免疫检查点抑制剂）产生耐药性等病理过程。

With zanzalintinib, .

使用赞扎林替尼，。

Exelixis

埃克塞利西斯

sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including neuroendocrine tumors, genitourinary, colorectal and head and neck cancers..

该公司在开发其旗舰药物卡博替尼的过程中，力求在其丰富的经验基础上进一步改善关键特性，包括药代动力学半衰期。 Zanzalintinib目前正被开发用于治疗晚期实体瘤，包括神经内分泌肿瘤、泌尿生殖系统肿瘤、结直肠癌以及头颈部癌症。

About RCC

关于RCC

Kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the

肾癌是男性和女性中十大最常诊断出的癌症之一。

U.S.

美国

Nearly 81,000 Americans will be diagnosed with kidney cancer in 2025.

2025年，将有近81,000名美国人被诊断出患有肾癌。

Clear cell RCC is the most common type of kidney cancer in adults.

透明细胞肾细胞癌是成人肾癌中最常见的类型。

Non-clear cell RCC represents about 25% of RCC cases, with fewer treatment options available and poorer outcomes compared with clear cell RCC.

非透明细胞肾细胞癌（RCC）约占肾细胞癌病例的25%，与透明细胞肾细胞癌相比，其治疗选择较少且预后较差。

Advanced or metastatic RCC occurs when the cancer has spread beyond the kidney.

肾细胞癌进展或转移时，癌症已经扩散到肾脏以外。

If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%.

如果在早期阶段发现，肾细胞癌的五年生存率很高；然而，对于晚期或转移性肾细胞癌患者，五年生存率仅为18%。

In 2025, approximately 33,700 patients with advanced kidney cancer will require systemic therapy in the

2025年，大约有33,700名晚期肾癌患者需要接受系统治疗。

U.S.

美国

, with over 21,400 patients receiving first-line treatment.

，超过 21,400 名患者接受了一线治疗。

About

关于

Exelixis

埃克塞利西斯

Exelixis

埃克塞利西斯

is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics.

是一家全球领先的肿瘤学公司，在癌症治疗的最前沿创新下一代药物和治疗方案。凭借卓越的药物发现与开发能力，我们正迅速拓展产品组合，针对不断扩大的肿瘤类型和适应症，通过临床差异化的候选管线，包括小分子、抗体药物偶联物和其他生物疗法。

This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX.

这一全面的方法利用了我们科学和合作伙伴关系数十年的坚实投资，以推进我们的研究计划并扩大我们旗舰商业产品CABOMETYX的影响力。

(cabozantinib).

（卡博替尼）。

Exelixis

埃克塞利西斯

is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit

是由大胆的科学追求驱动，致力于创造变革性的治疗方法，为更多患者带来未来的希望。如需了解公司及其帮助癌症患者更强健地康复、更长久地生活的使命，请访问

www.exelixis.com

, follow

，跟随

@ExelixisInc

on X (Twitter), like

在X（Twitter）上，像

Exelixis, Inc.

Exelixis公司

on Facebook and follow

在 Facebook 上关注并跟随

Exelixis

埃克塞利西斯

on LinkedIn.

在领英上。

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements, including, without limitation, statements related to: the presentation of results from the Phase 1b/2 STELLAR-002 trial at ASCO 2025; the therapeutic potential of zanzalintinib in combination with either nivolumab or a fixed-dose combination of nivolumab and relatlimab in patients with previously untreated advanced clear cell RCC and advanced solid tumors; and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future.

本新闻稿包含前瞻性声明，包括但不限于：在2025年ASCO会议上展示STELLAR-002一期b/二期试验的结果；zanzalintinib与nivolumab或nivolumab和relatlimab固定剂量组合在既往未接受治疗的晚期透明细胞肾细胞癌（RCC）和晚期实体瘤患者中的治疗潜力；以及Exelixis致力于科学追求，开发变革性疗法，为更多患者带来未来希望。

Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties.

任何涉及未来事件或情况的预期、预测或其他描述的声明均为前瞻性声明，这些声明基于Exelixis当前的计划、假设、信念、预期、估计和预测。前瞻性声明包含风险和不确定性。

Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; Exelixis’ and Bristol Myers Squibb’s continuing compliance with applicable legal and regulatory requirements; the potential failure of zanzalintinib in combination with either nivolumab or a fixed-dose combination of nivolumab and relatlimab to demonstrate safety and/or efficacy in future clinical testing; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating zanzalintinib; the costs of conducting clinical trials; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of zanzalintinib; Exelixis’ ability to protect its intellectual property rights; market competition; ch.

实际结果和事件发生的时间可能与前瞻性陈述中预期的情况大不相同，这是由于这些风险和不确定性所致，其中包括但不限于：在所述时间数据的可用性；Exelixis和百时美施贵宝持续遵守适用的法律和监管要求；zanzalintinib与nivolumab或nivolumab与relatlimab固定剂量组合在未来临床试验中可能无法证明安全性和/或有效性；评估zanzalintinib的临床试验中可能出现意外的安全性问题或额外数据分析引发的意外担忧；进行临床试验的成本；Exelixis对第三方供应商在zanzalintinib的开发、制造和供应上的依赖；Exelixis保护其知识产权的能力；市场竞争；等等。

Exelixis

埃克塞利西斯

and its development programs detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the

并且其开发计划在Exelixis最近的10-K年度报告和随后的10-Q季度报告中“风险因素”标题下不时详细说明，并将在Exelixis未来的文件中继续披露。

Securities and Exchange Commission

证券交易委员会

. All forward-looking statements in this press release are based on information available to

本新闻稿中的所有前瞻性陈述均基于可用信息。

Exelixis

埃克塞利西斯

as of the date of this press release, and

截至本新闻稿发布之日，且

Exelixis

埃克塞利西斯

undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

不承担更新或修改本文中包含的任何前瞻性陈述的义务，除非法律要求。

Exelixis

埃克塞利西斯

, the

，这个

Exelixis

埃克塞利西斯

logo and CABOMETYX are registered

商标和CABOMETYX已注册

U.S.

美国

trademarks of

商标

Exelixis

埃克塞利西斯

。

Opdivo

欧狄沃

is a registered trademark of

是注册商标，属于

Bristol Myers Squibb

百时美施贵宝

. Opdualag™ is a trademark of

Opdualag™ 是

Bristol Myers Squibb

百时美施贵宝

。

____________________

Cancer Facts & Figures 2025. ACS website. Available at:

2025年癌症事实与数据。ACS网站。可访问：

https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf

. Accessed

. 已访问

May 2025

2025年5月

。

What Is Kidney Cancer? ACS website. Available at:

什么是肾癌？ACS网站。可访问：

https://www.cancer.org/cancer/kidney-cancer/about/what-is-kidney-cancer.html

. Accessed

. 已访问

May 2025

2025年5月