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Ramucirumab: RELAY Primary Endpoint
The primary endpoint of the RELAY study was investigator-assessed PFS.
The information contained in this letter may notcompletely match the current local labeling for RAMUCIRUMAB.Please see local labeling approved in your country.
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
In the EGFR mutation-positive NSCLC setting, PFS is an appropriate, globally accepted endpoint. The primary endpoint was investigator-assessed PFS, defined as the time from the date of randomization until the date of radiographic documentation of progression (as defined by RECIST v1.1) or the date of death due to any cause, whichever was earlier.3 Censoring was taken in the following order.
If a patient did not have a baseline disease assessment, then the PFS time was censored at the randomization date, regardless of whether or not objective PD or death had been observed for the patient; otherwise,
If a patient was not known to have died or have investigator-assessed PD as of the data-inclusion cutoff date for the analysis, the PFS time was censored at the date of last postbaseline adequate radiological tumor assessment, or at the date of randomization if the patient did not have any postbaseline adequate radiological assessment.3
Analysis of Primary Outcome Measure
The analysis of PFS was based on a stratified, log-rank test and was planned to be performed after approximately 270 PFS events occurred (40% censoring rate) in order to provide 80% power to detect a HR of 0.71 at a two-sided alpha of 0.05. The HR and its 2-sided 95% CI were estimated using a stratified Cox proportional hazard model.2,3
1Nakagawa 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). Presented as an oral presentation 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
2Nakagawa 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
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
CTCAE = Common Terminology Criteria for Adverse Events
DCR = disease control rate
DOR = duration of response
ECOG = Eastern Cooperative Oncology Group
EGFR = epidermal growth factor receptor
HR = hazard ratio
NSCLC = non-small cell lung cancer
ORR = objective response rate
OS = overall survival
PD = progressive disease
PFS = progression-free survival
PFS2 = progression-free survival from randomization to progression (or death) on second-line systemic therapy
PS = performance status
RECIST = Response Evaluation Criteria in Solid Tumors
Fecha de la última revisión:2019 M07 29
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