Cyramza® (Ramucirumab)

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Ramucirumab: RELAY Primary Endpoint

The primary endpoint of the RELAY study was investigator-assessed PFS.

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The information contained in this letter may not completely match the current local labeling for RAMUCIRUMAB. Please see local labeling approved in your country. 

Study Design

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

Outcome Measures

The primary endpoint of the RELAY study was

  • PFS (investigator-assessed).2

Secondary endpoints included

  • OS
  • ORR (assessed using RECIST v1.1)
  • DCR
  • DOR, and 
  • safety (assessed using CTCAE v4.0).2

Prespecified exploratory analyses included

  • PFS2 (investigator-assessed), and
  • biomarker analyses.2

Assessment of Primary Outcome Measure

 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

References

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.

Glossary

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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