Bayer announced that the first patient has been enrolled in the global Phase III SOHO-02 trial, an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations.

拜耳宣布，第一名患者已参加全球III期SOHO-02试验，这是一项开放标签，随机，多中心的临床试验，评估研究药物BAY 2927088作为一线治疗晚期非小细胞肺癌（NSCLC）患者的疗效和安全性，其肿瘤具有激活HER2突变。

Beyond the SOHO-02 trial, investigational agent BAY 2927088 is also being assessed for its potential as a second-line therapy in adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. Late-breaking results from the phase I/II SOHO-01 trial will be presented in the presidential symposium at the World Conference on Lung Cancer (WCLC) in San Diego on Monday, September 9th, 2024..

除了SOHO-02试验之外，研究药物BAY 2927088也正在评估其作为二线治疗成人不可切除或转移性NSCLC患者的潜力，这些患者的肿瘤具有激活HER2（ERBB2）突变，并且之前接受过全身治疗。I/II期SOHO-01试验的最新突破性结果将于2024年9月9日（星期一）在圣地亚哥举行的世界肺癌会议（WCLC）总统研讨会上公布。。

“Our commitment to precision medicine is not just a promise but a mission to address the critical unmet needs of individuals battling HER2-mutant NSCLC, a variant of the most prevalent form of lung cancer,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division.

拜耳制药部研发负责人克里斯蒂安·隆美尔博士说：“我们对精准医学的承诺不仅是一个承诺，而且是一项使命，旨在解决与HER2突变型非小细胞肺癌（一种最常见的肺癌变体）作斗争的个体的关键未满足需求。”。

“By advancing innovative research, we are dedicated to improving survival rates for those affected by this devastating disease. This endeavor underscores our commitment to pioneering precise and personalized healthcare solutions for those in direct need.”.

“通过推进创新研究，我们致力于提高受这种毁灭性疾病影响的人的生存率。这一努力突显了我们致力于为直接需要的人开创精确和个性化的医疗保健解决方案。”。

Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. Lung cancer is the leading cause of cancer-related deaths worldwide. Currently there are no approved targeted first-line therapies for patients with NSCLC harboring HER2 activating mutations.

研究机构BAY 2927088来自拜耳与美国麻省理工学院和哈佛大学布罗德研究所的战略研究联盟。肺癌是全球癌症相关死亡的主要原因。目前，对于携带HER2激活突变的NSCLC患者，尚无批准的靶向一线治疗方法。

BAY 2927088 has received Breakthrough Therapy designation in the second-line setting from the FDA in February 2024. In June 2024, the Center for Drug Evaluation (CDE) in China also granted investigational agent BAY 2927088 Breakthrough Therapy designation for the same patient population..

BAY 2927088于2024年2月从FDA获得二线突破性治疗指定。2024年6月，中国药物评估中心（CDE）也为同一患者群体授予了研究药物BAY 2927088突破性治疗指定。。

About the SOHO-02 Study SOHO-02 is a global Phase III, open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy for adult patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations.

关于SOHO-02研究SOHO-02是一项全球III期开放标签随机多中心临床试验，评估研究药物BAY 2927088作为成人晚期非小细胞肺癌（NSCLC）患者一线治疗的疗效和安全性，其肿瘤具有激活HER2突变。

Participants will be randomized to either investigational agent BAY 2927088 or the current standard of care (cisplatin/carboplatin + pemetrexed + pembrolizumab). The primary endpoint of the study is progression free survival (PFS) measured by a blinded, independent, central review. Additional endpoints include overall response rate (ORR), duration of response (DoR) and evaluating the safety of investigational agent BAY 2927088..

参与者将被随机分配到研究药物BAY 2927088或目前的护理标准（顺铂/卡铂+培美曲塞+派姆单抗）。该研究的主要终点是通过盲法，独立的中央评估测量的无进展生存期（PFS）。其他终点包括总体缓解率（ORR），缓解持续时间（DoR）和评估研究药物BAY 2927088的安全性。。

Condition: NSCLC/HER 2

病情：NSCLC/HER 2

Type: drug

类型：药物