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The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1
Progression-Free Survival 2
RELAY PFS2 was defined as the time from randomization to second disease progression (objective radiological or symptomatic progression after start of additional systematic anticancer treatment) or death from any cause, whichever came first. Although not mandatory, PFS2 based on radiographic assessment was recommended.2 Progression-free survival 2 analysis included patients that continued erlotinib beyond first RECIST defined progression.2
If the patient was alive at the cutoff for analysis and a second disease progression had not been observed, PFS2 data was to be censored on the last date the patient was known to be alive.2
The analysis of PFS2 was based on stratified log-rank test, stratified by randomization strata (IWRS). Progression-free survival 2 median with 95% CI and survival curves for each treatment group was estimated using Kaplan-Meier method. The HR was estimated using a stratified Cox regression model, stratified by randomization strata (IWRS). At the time of data cutoff, 69% of the RELAY ITT patients were censored for PFS2 analysis. RELAY PFS2 efficacy is summarized in Figure 1.
Figure 1. Kaplan-Meier of PFS2 by Investigator Assessment in the ITT Population in RELAY2
Abbreviations: HR = hazard ratio; ITT = intent-to-treat; NR = not reached; PFS2 = progression-free survival 2.
The median PFS2 has not yet been reached for either treatment group.1
1. Nakagawa K, Garon E, Seto T, et al. RELAY: A multicenter, double-blind, randomized, phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). Talk presented at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. https://meetinglibrary.asco.org/record/173373/abstract
2. Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5
ECOG = Eastern Cooperative Oncology Group
EGFR = epidermal growth factor receptor
HR = hazard ratio
ITT = intention-to-treat
IWRS = interactive voice/web response system
NSCLC = non-small cell lung cancer
PFS2 = progression-free survival 2
PS = performance status
RECIST = Response Evaluation Criteria in Solid Tumors
Datum fӧr senaste ӧversyn 2019 M10 22