METLung:奥沙利umab 联合厄洛替尼对比厄洛替尼治疗既往治疗的 IIIB 或 IV 期非小细胞肺癌的 III 期随机试验结果
Results From the Phase III Randomized Trial of Onartuzumab Plus Erlotinib Versus Erlotinib in Previously Treated Stage IIIB or IV Non-Small-Cell Lung Cancer: METLung.
机构信息
David R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
出版信息
J Clin Oncol. 2017 Feb;35(4):412-420. doi: 10.1200/JCO.2016.69.2160. Epub 2016 Dec 12.
Purpose The phase III OAM4971g study (METLung) examined the efficacy and safety of onartuzumab plus erlotinib in patients with locally advanced or metastatic non-small-cell lung cancer selected by MET immunohistochemistry whose disease had progressed after treatment with a platinum-based chemotherapy regimen. Patients and Methods Patients were randomly assigned at a one-to-one ratio to receive onartuzumab (15 mg/kg intravenously on day 1 of each 21-day cycle) plus daily oral erlotinib 150 mg or intravenous placebo plus daily oral erlotinib 150 mg. The primary end point was overall survival (OS) in the intent-to-treat population. Secondary end points included median progression-free survival, overall response rate, biomarker analysis, and safety. Results A total of 499 patients were enrolled (onartuzumab, n = 250; placebo, n = 249). Median OS was 6.8 versus 9.1 months for onartuzumab versus placebo (stratified hazard ratio [HR], 1.27; 95% CI, 0.98 to 1.65; P = .067), with a greater number of deaths in the onartuzumab arm (130 [52%] v 114 [46%]). Median progression-free survival was 2.7 versus 2.6 months (stratified HR, 0.99; 95% CI, 0.81 to 1.20; P = .92), and overall response rate was 8.4% and 9.6% for onartuzumab versus placebo, respectively. Exploratory analyses using MET fluorescence in situ hybridization status and gene expression showed no benefit for onartuzumab; patients with EGFR mutations showed a trend toward shorter OS with onartuzumab treatment (HR, 4.68; 95% CI, 0.97 to 22.63). Grade 3 to 5 adverse events were reported by 56.0% and 51.2% of patients, with serious AEs in 33.9% and 30.7%, for experimental versus control arms, respectively. Conclusion Onartuzumab plus erlotinib did not improve clinical outcomes, with shorter OS in the onartuzumab arm, compared with erlotinib in patients with MET-positive non-small-cell lung cancer.
目的
III 期 OAM4971g 研究(METLung)评估了 mertuzumab 联合厄洛替尼在经含铂化疗方案治疗后疾病进展的 MET 免疫组化选择的局部晚期或转移性非小细胞肺癌患者中的疗效和安全性。
方法
患者以 1:1 的比例随机分配,接受 mertuzumab(15mg/kg,每 21 天周期的第 1 天静脉注射)联合每日口服厄洛替尼 150mg 或安慰剂静脉注射联合每日口服厄洛替尼 150mg。主要终点是在意向治疗人群中的总生存期(OS)。次要终点包括中位无进展生存期、总缓解率、生物标志物分析和安全性。
结果
共纳入 499 例患者(mertuzumab 组,n=250;安慰剂组,n=249)。mertuzumab 组和安慰剂组的中位 OS 分别为 6.8 个月和 9.1 个月(分层风险比[HR],1.27;95%CI,0.98 至 1.65;P=0.067),mertuzumab 组死亡人数更多(130 [52%] 例比 114 [46%] 例)。中位无进展生存期分别为 2.7 个月和 2.6 个月(分层 HR,0.99;95%CI,0.81 至 1.20;P=0.92),mertuzumab 组和安慰剂组的总缓解率分别为 8.4%和 9.6%。使用 MET 荧光原位杂交状态和基因表达的探索性分析显示 mertuzumab 无获益;EGFR 突变患者使用 mertuzumab 治疗的 OS 更短(HR,4.68;95%CI,0.97 至 22.63)。mertuzumab 组和安慰剂组分别有 56.0%和 51.2%的患者发生 3 级至 5 级不良事件,实验组和对照组分别有 33.9%和 30.7%的患者发生严重不良事件。
结论
与厄洛替尼相比,在 MET 阳性非小细胞肺癌患者中,mertuzumab 联合厄洛替尼并未改善临床结局,mertuzumab 组的 OS 更短。