Cyramza® (Ramucirumab)

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Ramucirumab: EGFR Testing Methods in the RELAY Study

All patients were assessed for EGFR mutation status prior to study enrollment.

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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

Assessment of EGFR Mutation Status

All patients were assessed for EGFR mutation status prior to study enrollment and all patients were required to have an EGFR mutation of exon 19 deletion or exon 21 L858R.1 Baseline patient characteristics related to EGFR status are summarized in Patient Demographics and Baseline Characteristics Related to EGFR Status.

Patient Demographics and Baseline Characteristics Related to EGFR Status1

Characteristic

RAM + ERL
n=224

PBO + ERL
n=225

EGFR mutation typea, n (%)

Exon 19 deletion

123 (55)

121 (54)

Exon 21 (L858R) mutation

101 (45)

104 (46)

EGFR testing methoda, n (%)

Therascreen® (Qiagen) and Cobas® (Roche)

96 (43)

101 (45)

Other PCR and sequencing-based methods

127 (57)

124 (55)

Abbreviations: EGFR = epidermal growth factor receptor; ERL = erlotinib; PBO = placebo; PCR = polymerase chain reaction; RAM = ramucirumab. 

aDetermined by local testing.

Central Testing for Confirmation of EGFR Mutation

Local EGFR testing results were used for enrollment into the study;  pre-planned central testing was conducted during the study using the therascreen® EGFR tissue assay on submitted archival tissue samples to corroborate activating mutation status. Central testing did not inform patient eligibility or study enrollment.2

Among the 316 patients (70% of the ITT population) with results obtained from the central therascreen® testing, 305 patients (96%) had an EGFR activating mutation detected, corroborating the local EGFR testing results used for enrollment. It is expected that the lack of a positive EGFR central test result in the 11 patients is likely due to tissue heterogeneity and the different tissue sections used for central versus local testing.2

Summarized by local testing method, activating EGFR mutations were detected centrally in

  • 95% of tested patients who had been tested locally with a therascreen®/cobas® test, and
  • 97% of tested patients who had been tested locally with an Other test.2

The similar EGFR activating mutation positivity rates found by central testing between the 2 local testing method subgroups, indicates that the difference in HRs observed between patients tested locally with therascreen®/cobas® vs. Other tests was not due to false positives from local assay variability. Additionally, when the 11 patients were removed for whom an EGFR activating mutation could not be detected in the samples submitted and tested centrally, the HR was essentially the same as that within the full set of centrally tested patients (HR=0.623 for patients with central tissue test [n=316]; HR=0.610 for patients with positive central tissue test [n=305]).2

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). 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

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

HR = hazard ratio

ITT = intent-to-treat

NSCLC = non-small cell lung cancer

PS = performance status

Fecha de la última revisión: 2019 M07 26


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