– Bayer today announced that the investigational compound sevabertinib (BAY 2927088) has been granted Priority Review status by the US Food and Drug Administration (FDA) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2/ERBB2) mutations and who have received a prior systemic therapy.

– 拜耳今天宣布，其在研化合物sevabertinib（BAY 2927088）已获得美国食品药品监督管理局（FDA）的优先审评资格，用于治疗携带激活型人表皮生长因子受体2（HER2/ERBB2）突变的晚期非小细胞肺癌（NSCLC）成年患者，这些患者此前已接受过系统性治疗。

Sevabertinib is an oral, small molecule, tyrosine kinase inhibitor (TKI)..

Sevabertinib是一种口服的小分子酪氨酸激酶抑制剂（TKI）。

“Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that validates both the unmet need and the potential for sevabertinib to fulfill that need,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

“HER2突变型非小细胞肺癌患者多为女性，可能较为年轻且不吸烟。FDA决定对我们的sevabertinib申请给予优先审查资格，这是验证了未满足需求及sevabertinib满足该需求潜力的重要里程碑，”拜耳制药全球产品战略与商业化执行副总裁兼制药领导团队成员克里斯汀·罗斯表示。

“If approved, sevabertinib will help address critical unmet needs and improve outcomes for these patients, who currently have a poor prognosis and limited treatment options.”.

“如果获得批准，sevabertinib将有助于满足关键的未满足需求，并改善这些患者的预后，这些患者目前预后较差且治疗选择有限。”

The regulatory application for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial in patients with advanced NSCLC harboring a HER2-activating mutation, with disease progression after ≥1 systemic therapies for advanced disease, and who were naïve to treatment with a HER2-targeted TKI..

Sevabertinib的注册申请基于正在进行的I/II期SOHO-01试验的积极结果，该试验针对携带HER2激活突变的晚期非小细胞肺癌（NSCLC）患者，这些患者在至少一种系统性治疗后疾病进展，并且未接受过HER2靶向酪氨酸激酶抑制剂（TKI）治疗。

The Breakthrough Therapy designation for sevabertinib was supported by preliminary clinical evidence from the SOHO-01 trial. A Breakthrough Therapy designation is specifically designed to expedite the development and review of investigational medicines that have the potential to provide substantial improvement over available therapies in areas of high unmet medical need.

Sevabertinib的突破性疗法认定得到了来自SOHO-01试验的初步临床证据的支持。突破性疗法认定专门旨在加速有可能在高度未满足医疗需求的领域提供比现有疗法显著改善的在研药物的开发和审评。

By expediting the development and review process via a Breakthrough Therapy designation, promising therapies can be made available to patients as quickly and as safely as possible..

通过突破性疗法指定加快开发和审查进程，可以尽快并尽可能安全地将有希望的疗法提供给患者。

Results from SOHO-01 (NCT05099172)

SOHO-01（NCT05099172）研究结果

SOHO-01 is an ongoing, open-label, multicenter Phase I/II study. The latest results are from two expansion cohorts; patients with advanced NSCLC with HER2-activating mutations who had disease progression after ≥1 systemic therapies and were either naïve to HER2-targeted therapy (Cohort D) or previously treated with HER2-targeted antibody-drug conjugates (Cohort E).

SOHO-01是一项正在进行的开放标签、多中心I/II期研究。最新结果来自两个扩展队列：携带HER2激活突变的晚期非小细胞肺癌患者，这些患者在接受≥1种系统治疗后疾病进展，且既往未接受过HER2靶向治疗（队列D）或曾接受过HER2靶向抗体药物偶联物治疗（队列E）。

Both cohorts received oral sevabertinib 20 mg twice daily..

两个队列均每日两次口服塞瓦贝汀20毫克。

As of October 14, 2024, 44 patients from cohort D and 34 patients from cohort E were treated. The investigator-assessed objective response rate was 70.5% (95% CI 54.8, 83.2) in D and 35.3% (95% CI 19.7, 53.5) in E. The disease control rates (response or stable disease for ≥12 weeks) were 81.8% (D) and 52.9% (E).

截至2024年10月14日，已对D组的44名患者和E组的34名患者进行了治疗。研究者评估的客观缓解率在D组为70.5%（95%置信区间54.8, 83.2），在E组为35.3%（95%置信区间19.7, 53.5）。疾病控制率（缓解或稳定疾病≥12周）分别为81.8%（D组）和52.9%（E组）。

Median duration of response (DOR) was 8.7 months (95% CI 4.5, not estimable [NE]) in D and 9.5 months (95% CI 4.1, NE) in E..

D组的反应持续时间（DOR）中位数为8.7个月（95%置信区间4.5，不可估计[NE]），E组为9.5个月（95%置信区间4.1，NE）。

The safety profile of sevabertinib was found to be manageable, and consistent with previous reports. Treatment-related adverse events (TRAEs) were reported in 97.4% of patients; diarrhea was the most common TRAE leading to dose reduction, but no patients discontinued treatment due to diarrhea. There were no cases of interstitial lung disease..

塞瓦伯替尼的安全性被认为是可管理的，并与之前的报告一致。97.4%的患者报告了治疗相关的不良事件（TRAEs）；腹泻是最常见的导致剂量减少的TRAE，但没有患者因腹泻而停止治疗。未发现间质性肺病的病例。

About sevabertinib (BAY 2927088)

关于sevabertinib（BAY 2927088）

Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring human epidermal growth factor receptors 2 (HER2) activating mutations.

Sevabertinib 是一种研究性药物，尚未获得任何卫生部门的批准在任何国家用于任何适应症。它目前正被评估作为携带人类表皮生长因子受体2（HER2）激活突变的非小细胞肺癌（NSCLC）患者的潜在新靶向治疗选择。

The ongoing Phase III SOHO-02 trial (NCT 06452277) is evaluating BAY 2927088 as a first-line treatment option for these patients. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations (panSOHO), excluding advanced non-small cell lung cancer (NSCLC).

正在进行的 III 期 SOHO-02 试验（NCT 06452277）正在评估 BAY 2927088 作为这些患者的一线治疗选择。Sevabertinib 还在研究用于携带 HER2 激活突变的转移性或不可切除实体瘤（panSOHO）患者，但不包括晚期非小细胞肺癌（NSCLC）。

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA..

Sevabertinib 是一种口服、可逆的酪氨酸激酶抑制剂 (TKI)，能够有效抑制突变型 HER2，包括 HER2 第 20 外显子插入和 HER2 点突变，以及表皮生长因子受体 (EGFR)，并对突变型与野生型 EGFR 具有高选择性。研究药物 Sevabertinib 源自拜耳与美国马萨诸塞州剑桥市麻省理工学院和哈佛大学布罗德研究所的战略研究联盟。

About Non-Small Cell Lung Cancer (NSCLC)

关于非小细胞肺癌（NSCLC）

Lung cancer is the leading cause of cancer-related deaths worldwide. Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat.

肺癌是全球癌症相关死亡的主要原因。非小细胞肺癌（NSCLC）是最常见的肺癌类型，占病例的85%以上。在晚期NSCLC中，有2%到4%的患者存在激活的HER2突变。80%的被诊断为NSCLC的患者已经进展到晚期阶段，这使得治疗更加困难。

Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies..

目前，HER2突变型非小细胞肺癌患者面临治疗选择有限的问题，凸显出对更有效疗法的迫切需求。

About Oncology at Bayer

拜耳肿瘤学相关

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development.

拜耳致力于通过推进一系列创新治疗方案来为更美好的生活提供科学支持。公司充满热情和决心，开发能够帮助改善和延长癌症患者生命的新药。拜耳的肿瘤学产品组合包括多种已上市的产品，涵盖不同的适应症，同时还有多个化合物处于临床开发的不同阶段。

We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread..

我们在肿瘤内在通路、靶向放射性核素治疗和下一代免疫肿瘤学等领域拥有丰富的专业知识。我们正在推动前列腺癌治疗从早期到转移阶段的发展，目标是延长生存期并减少副作用。拜耳专注于创新精准肿瘤治疗，其中包括一种获批的TRK抑制剂，专门用于治疗携带NTRK基因融合的肿瘤，这种基因融合是肿瘤生长和扩散的致癌驱动因素。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，该集团拥有约93,000名员工，销售额达466亿欧元。