UNASSIGNED:在一项2期研究的主要分析中,发现Savolitinib在中国肺肉瘤样癌和其他MET外显子14跳跃改变(METex14阳性)的NSCLC患者中具有令人鼓舞的抗肿瘤活性和良好的安全性。这里,我们提供了savolitinib的长期疗效和安全性数据,包括亚组分析。
未经评估:此多中心,单臂,开放标签,中华人民共和国的2期研究纳入了MET抑制剂初治的成人局部晚期或转移性METex14阳性NSCLC(NCT02897479).每天一次施用400或600mg剂量的口服savolitinib(体重依赖性)。最终分析的主要目标是长期总生存期(OS)和先前系统治疗的亚组分析,NSCLC亚型,和脑转移。
UNASSIGNED:在最终分析截止日期(2021年6月28日),共有70例患者被纳入并接受了savolitinib,中位随访时间为28.4个月(四分位距:26.2-36.3个月)。中位OS为12.5个月(95%置信区间[CI]:10.5-21.4[18和24个月OS率,42.1%和31.5%,分别])。治疗前或未接受治疗的患者的中位OS为19.4(95%CI:10.5-31.3)和10.9(95%CI:7.5-14.0)个月,肺肉瘤样癌患者分别为10.6个月(95%CI:4.6-14.0),其他非小细胞肺癌亚型为17.3个月(95%CI:10.6-23.6),和17.7个月(95%CI:10.5-不可评估)的脑转移患者。长时间的随访和暴露没有出现新的安全信号。
UNASSIGNED:更新的结果进一步证实了savolitinib在中国METex14阳性NSCLC患者中的有利益处和可接受的安全性。
UNASSIGNED: Savolitinib has been found to have encouraging antitumor activity and a favorable safety profile in Chinese patients with pulmonary sarcomatoid carcinoma and other NSCLCs with MET exon 14 skipping alterations (MET ex14 positive) at the primary analysis of a phase 2 study. Here, we present the long-term efficacy and safety data of savolitinib, including subgroup analyses.
UNASSIGNED: This multicenter, single-arm, open-label, phase 2 study in the People\'s Republic of China enrolled MET inhibitor-naive adults with locally advanced or metastatic METex14-positive NSCLC (NCT02897479). Oral savolitinib at a dose of 400 or 600 mg was administered once daily (body weight dependent). The primary objectives of the final analysis were long-term overall survival (OS) and subgroup analyses by previous systemic treatment, NSCLC subtypes, and brain metastases.
UNASSIGNED: At the final analysis cutoff date (June 28, 2021), a total of 70 patients were enrolled and receiving savolitinib, and median follow-up was 28.4 (interquartile range: 26.2-36.3) months. The median OS was 12.5 months (95% confidence interval [CI]: 10.5-21.4 [18- and 24-mo OS rates, 42.1% and 31.5%, respectively]). Median OS in pretreated or treatment-naive patients was 19.4 (95% CI: 10.5-31.3) and 10.9 (95% CI: 7.5-14.0) months, respectively; it was 10.6 months (95% CI: 4.6-14.0) in patients with pulmonary sarcomatoid carcinoma, 17.3 months (95% CI: 10.6-23.6) in other NSCLC subtypes, and 17.7 months (95% CI: 10.5-not evaluable) in patients with brain metastases. No new safety signals emerged with prolonged follow-up and exposure.
UNASSIGNED: The updated results further confirm the favorable benefit and acceptable safety of savolitinib in Chinese patients with METex14-positive NSCLC.