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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 Pulmonary Hemorrhage/Hemoptysis in RELAY
RELAY exclusion criteria related to pulmonary hemorrhage events included
radiologically documented evidence of major blood vessel invasion or encasement by cancer,
radiographic evidence of intratumor cavitation, regardless of tumor histology, and
a history of gross hemoptysis (defined as the presence of ≥½ teaspoon of gross blood) within 2 months prior to enrollment.1
The investigator could discontinue a patient from ramucirumab/placebo for hemoptysis that exceeded the severity grade present at baseline.1
Treatment-emergent adverse events of pulmonary hemorrhage and hemoptysis are presented in Table 1.
Table 1. Treatment Emergent Adverse Events of Pulmonary Hemorrhage and Hemoptysis in RELAY1
TEAE, n (% of patients)a |
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
Ramucirumab
+ Erlotinib |
Placebo
+ Erlotinib |
|||
Pulmonary hemorrhage eventsb |
14 (6) |
0 (0) |
4 (2) |
1 (<1) |
Hemoptysis |
12 (5) |
0 (0) |
2 (1) |
1 (<1) |
Abbreviation: TEAE = treatment-emergent adverse event.
a Adverse events of special interest are those associated with ramucirumab treatment in previous clinical trials of non-small-cell lung cancer, gastric cancer, urothelial cancer, and hepatocellular carcinoma.
b One death occurred on study and was because of a pulmonary hemorrhage event of hemothorax.
Ramucirumab is an antiangiogenic therapy and has the potential to increase the risk of severe bleeding. Permanently discontinue ramucirumab/placebo in patients who experience grade 3 or 4 bleeding.1
Efficacy data from RELAY patients who developed pulmonary hemorrhage and/or hemoptysis have not been evaluated.
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
Glossary
ECOG = Eastern Cooperative Oncology Group
EGFR = epidermal growth factor receptor
NSCLC = non-small cell lung cancer
PS = performance status
Datum fӧr senaste ӧversyn 2019 M10 11