RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC.

Here, we report the final overall survival(OS; secondary end point) outcomes for the intention-to-treatpopulation.

在这里，我们报告了意向治疗人群的最终总生存期（OS；次要终点）结果。

Methods

Between January 2016 and February 2018, 449 eligible patients with an EGFR exon 19del or L858R mutation and no central nervous system metastases were randomized (1:1) to ERL (150 mg/day) with RAM (10 mg/kg every two weeks, N = 224) or placebo (N = 225).

在2016年1月至2018年2月期间，共有449名符合条件的患者，这些患者携带EGFR外显子19del或L858R突变，且无中枢神经系统转移，被随机（1:1）分配至ERL（每天150毫克）联合RAM（每两周10毫克/公斤，N=224）或安慰剂（N=225）治疗。

Results

At data cutoff, 297 deaths were reported (overall event rate = 66%), with a median follow-up of 45.1 months (interquartile range: 26.7-71.2), an OS HR of 0.98 (95% CI: 0.78-1.24, p = 0.864), and median OS of 51.1 months (RAM + ERL) and 46.0 months (placebo + ERL).

在数据截止时，共报告了297例死亡（总事件率为66%），中位随访时间为45.1个月（四分位数范围：26.7-71.2），总生存期（OS）风险比（HR）为0.98（95%置信区间：0.78-1.24，p=0.864），以及RAM+ERL组的中位总生存期为51.1个月，安慰剂+ERL组为46.0个月。

Outcomes in subsets of patients with poor prognosis (L858R or TP53 co-mutation) suggest a directional improvement in OS (L858R: HR = 0.87, 95% CI: 0.62-1.22; exon 19del: HR = 1.13, 95% CI: 0.83-1.55; TP53 co-mutation: HR = 0.83, 95% CI: 0.58-1.19; TP53-wild-type: HR = 1.22, 95% CI: 0.87-1.72).

在预后较差的患者亚组（L858R或TP53共突变）中，总生存期（OS）显示出方向性的改善（L858R: HR = 0.87, 95% 置信区间: 0.62-1.22; 外显子19缺失: HR = 1.13, 95% 置信区间: 0.83-1.55; TP53共突变: HR = 0.83, 95% 置信区间: 0.58-1.19; TP53野生型: HR = 1.22, 95% 置信区间: 0.87-1.72）。

Treatment-emergent T790M rates were similar between arms.

两组之间的治疗后出现的T790M突变率相似。

Over 80% of patients received post-study discontinuation therapy (>50% received osimertinib in comparable numbers between arms).

超过80%的患者在研究结束后接受了治疗（两组之间有超过50%的患者接受了类似数量的奥希替尼治疗）。

The safety profile for RAM + ERL was consistent with previous reports with no increased toxicity over time or new safety signals observed.

RAM + ERL的安全性特征与以往报告一致，随时间推移没有增加的毒性或新的安全信号被观察到。

Conclusions

In RELAY, OS was not significantly improved with similar long OS durations in both treatment arms.

在RELAY研究中，总生存期（OS）在两组治疗中均未显著改善，两组的总生存期持续时间相似。

clinical_trial_information

ClinicalTrials.gov Identifier: NCT02411448.

ClinicalTrials.gov注册号：NCT02411448。