Exelixis的Zanzalintinib组合提升结直肠癌生存率，股价飙升-动脉网

Exelixis' Zanzalintinib Combo Boosts Survival In Colorectal Cancer, Stock Soars

benzinga 等信源发布 2025-06-23 10:37

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On Sunday,

周日，

Exelixis, Inc.

Exelixis公司

EXEL

revealed topline results from the STELLAR-303 phase 3 pivotal trial of zanzalintinib (100 mg)

公布了zanalintinib（100毫克）STELLAR-303三期关键试验的顶线结果

combined with atezolizumab

结合阿特珠单抗

。

The study includes patients with previously treated non-microsatellite instability (MSI)-high

该研究包括之前接受过治疗的非微卫星不稳定性（MSI）高患者。

metastatic colorectal cancer (CRC)

转移性结直肠癌 (CRC)

。

Zanzalintinib in combination with

Zanzalintinib 联合

Roche Holdings AG

罗氏控股公司

RHHBY

罗氏制药

atezolizumab (Tecentriq) demonstrated a statistically significant improvement in overall survival (OS) versus Bayer AG

阿特珠单抗（Tecentriq）相较于拜耳公司显示出总体生存期（OS）的统计学显著改善。

BAYRY

拜耳（BAYRY）

Stivarga (regorafenib).

Stivarga（瑞戈非尼）。

Also Read:

另请阅读：

Exelixis Stock Soars As Analysts Applaud Raised 2025 Guidance, Q1 Earnings Beat

Exelixis股票因分析师赞赏上调2025年指导和第一季度盈利超预期而飙升

These topline findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial.

这些头条结果来自独立数据监查委员会对STELLAR-303三期试验的两个主要终点之一进行的最终分析。

The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases, NLM).

试验将对无肝转移（非肝转移，NLM）患者的其他双重主要终点OS进行计划中的最终分析。

The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified.

赞扎利替尼与阿特珠单抗联用以及瑞戈非尼的安全性特征总体上与之前观察到的一致，未发现新的安全性信号。

Secondary endpoints of STELLAR-303 include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. Exelixis plans to submit detailed results of STELLAR-303 for presentation at an upcoming medical conference.

STELLAR-303 的次要终点包括意向治疗（ITT）人群和 NLM 患者亚组中的无进展生存期、客观缓解率和缓解持续时间。Exelixis 计划提交 STELLAR-303 的详细结果，以便在即将召开的医学会议上展示。

Following this positive news, analysts at

在此利好消息之后，分析师们

William Blair

威廉·布莱尔

said that the announcement “represents the first pivotal success from the zanzalintinib program, and we are encouraged that the STELLAR-303 study met one of the dual primary endpoints of overall survival among the intent-to-treat population, representing the largest commercial opportunity (risk-adjusted U.S.

表示该公告“代表了赞扎利替尼项目的首个关键成功，我们备受鼓舞的是，STELLAR-303 研究在意向治疗人群中达到了双重主要终点之一的总生存期，这代表着最大的商业机会（经风险调整后的美国市场）。

peak sales of $875 million, according to our estimates).”.

根据我们的估计，销售额峰值将达到8.75亿美元。

Management had earlier projected that zanzalintinib could reach $5 billion in U.S. net product sales by 2033, with 45% expected from genitourinary cancers, another 45% from gastrointestinal cancers, and the remaining 10% from head-and-neck cancers. Analyst

管理层早前预测，到2033年，赞扎利尼布在美国的净产品销售额可能达到50亿美元，其中45%来自泌尿生殖系统癌症，另外45%来自胃肠道癌症，剩余10%来自头颈癌。分析师

Andy Hsieh

谢安迪

asserted that the early positive results from the STELLAR-303 trial mark the first step toward reaching that target.

断言 STELLAR-303 试验的早期积极结果标志着实现该目标的第一步。

He added, “From a stock perspective, given its substantial and likely durable cash flow generation into early 2030, we continue to believe Exelixis provides investors with a highly defensive investment profile. We also believe that the strategic positioning outlined by Exelixis should drive moderate growth into the next decade.”.

他补充道：“从股票的角度来看，鉴于其在2030年初将实现可观且可能持久的现金流生成，我们仍然认为Exelixis为投资者提供了一个高度防御性的投资组合。我们还认为，Exelixis所概述的战略定位应会推动公司在未来十年实现适度增长。”

Adding to Exelixis’ recent positive developments, its partner Ipsen also recently achieved a regulatory milestone.

除了Exelixis最近的积极进展外，其合作伙伴Ipsen也刚刚达成了一个监管里程碑。

On Friday, Exelixis’ partner Ipsen received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use for Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well-differentiated extra-pancreatic and pancreatic neuroendocrine tumors who have progressed following at least one prior systemic therapy .

周五，Exelixis的合作伙伴Ipsen收到欧洲药品管理局人用药品委员会的积极意见，支持Cabometyx（cabozantinib）用于治疗不可切除或转移性、高分化的胰腺外和胰腺神经内分泌肿瘤的成年患者，这些患者在至少一种先前的全身治疗后病情进展。

other than somatostatin analogs

除了生长抑素类似物之外

。

A regulatory decision by the European Medicines Agency is anticipated in 2025. In March 2025, the U.S. Food and Drug Administration approved

预计欧洲药品管理局将在2025年作出监管决定。2025年3月，美国食品药品监督管理局批准了该药物。

Cabometyx in this setting

在这种情况下，Cabometyx

。

Price Action:

价格行为:

EXEL stock is trading higher by 11.1% to $44.85 at last check Monday.