These Phase III data are the first and only to show an improvement in disease-free survival in early-stage resected ALK-positive non-small cell lung cancer (NSCLC) With about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy,1 more effective treatment options are urgently needed to provide the best chance for cure2Data are being presented as a late-breaking oral during the ESMO 2023 Presidential Symposium Basel, 18 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the primary analysis of the Phase III ALINA study demonstrating a statistically significant and clinically meaningful improvement in disease-free survival (DFS; primary endpoint).

这些III期数据是第一个也是唯一一个显示早期切除ALK阳性非小细胞肺癌（NSCLC）无病生存率提高的数据，约有二分之一的早期NSCLC患者术后出现疾病复发尽管进行了辅助化疗，1迫切需要更有效的治疗方案，以提供治疗的最佳机会2在ESMO 2023年总统研讨会巴塞尔期间，数据被列为开创性的口头报告，2023年10月18日-罗氏（SIX:RO，ROG；OTCQX:RHHBY）今天公布了III期ALINA研究的初步分析结果，证明无病生存率（DFS；主要终点）具有统计学意义和临床意义的改善。

The study results showed that Alecensa® (alectinib) reduces the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).3 A clinically meaningful improvement of central nervous system (CNS)-DFS was also observed (HR=0.22; 95% CI: 0.08-0.58).3 The safety and tolerability of Alecensa in this trial were consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.3 Overall survival data were immature at the time of this analysis and follow-up is ongoing to report a more mature estimate.3 The full results of ALINA are being presented as a late-breaking oral at the European Society of Medical Oncology (ESMO) Congress 2023 Presidential Symposium on Saturday 21 October 2023.

研究结果显示，与铂类化疗相比，Alecensa®（alectinib）可将疾病复发或死亡风险降低76%（风险比[HR]=0.24,95%CI:0.13-0.43，p<0.0001）完全切除的IB期（肿瘤≥4cm）至IIIA期（UICC/AJCC第7版）间变性淋巴瘤激酶（ALK）阳性非小细胞肺癌（NSCLC）.3具有临床意义还观察到中枢神经系统（CNS）-DFS的改善（HR=0.22；95%CI:0.08-0.58）.3该试验中Alecensa的安全性和耐受性与先前在转移性环境中的试验一致，并且没有意外的安全性观察结果.3在进行此分析时，总生存数据尚不成熟，正在进行随访以报告更成熟的估计值.3ALINA的结果将于2023年10月21日星期六在2023年欧洲肿瘤内科学会（ESMO）大会上作为晚些时候的演讲发表。

These data will be submitted to global health authorities, including the U.S. .

这些数据将提交给全球卫生当局，包括美国。

Attachment

附件

18102023_MR_ALINA data release_STAGE III_en

18102023_MR_ALINA数据发布_STAGE III_en