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Cyramza ® (ramucirumab)
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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
Incidence of Pneumonitis/Interstitial Lung Disease
Treatment-emergent adverse events of pneumonitis and ILD are presented in Table 1.
Table 1. Treatment-Emergent Adverse Events of Pneumonitis and Interstitial Lung Disease in the Safety Population in RELAY1,2
|
TEAE, n (% of patients)
|
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
Ramucirumab
+ Erlotinib |
Placebo
+ Erlotiniba |
|||
|
ILD or Pneumonitisb |
4 (2) |
1 (<1) |
7 (3) |
3 (1) |
Abbreviations: EGFR = epidermal growth factor receptor; ILD = interstitial lung disease; n=number of patients; TEAE = treatment-emergent adverse events.
a One patient in the placebo group had a fatal event of ILD more than 30 days after treatment discontinuation.
b Data for ILD and pneumonitis are here because these are related and previously associated with EGFR tyrosine kinase inhibitors.
A similar proportion of Asian and non-Asian patients had ILD that included
9 (3%) of 344 Asian patients, and
2 (2%) of 102 non-Asian patients.1
Due to the small sample size of patients who developed ILD/pneumonitis while on study, no specific efficacy analyses was performed for these patients.
1. 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
2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
ECOG = Eastern Cooperative Oncology Group
EGFR = epidermal growth factor receptor
ILD = interstitial lung disease
NSCLC = non-small cell lung cancer
PS = performance status
Datum fӧr senaste ӧversyn 2019 M10 11