Results from the phase 3 RELAY trial of ramucirumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in previously untreated patients with metastatic EGFR-mutated non-small cell lung cancer (NSCLC) compared with erlotinib alone, according to a study published in The Lancet Oncology.
The multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of ramucirumab in combination with erlotinib in previously untreated patients with metastatic EGFR-mutated NSCLC (N=449). Patients were randomized 1:1 to receive oral erlotinib 150mg once daily with either intravenous (IV) ramucirumab 10mg/kg (n=224) or matching placebo (n=225) once every 2 weeks. The primary end point was the investigator-assessed PFS in the intention-to-treat population.
Ramucirumab plus erlotinib showed a statistically significant improvement in median PFS by 7 months compared with placebo plus erlotinib (19.4 months vs 12.4 months, respectively; HR 0.59; 95% CI, 0.46-0.79; P ≤.0001). Additionally, secondary and exploratory end points (eg, duration of response, PFS2, time on targeted therapy) were observed to have improved across all subgroups, including those with exon 19 and 21 mutation; study data for overall survival (OS) was immature at the time of analysis.
With regard to safety, the most common treatment-emergent Grade ≥3 adverse events observed in the ramucirumab plus erlotinib group were hypertension (24%), dermatitis acneiform (15%), and diarrhea (7%).
“The findings from RELAY show the utility of targeting the VEGFR and EGFR pathways together in this setting, and validate previous non-clinical and clinical studies which demonstrated interactions between EGFR and VEGFR2 signaling in the setting of EGFR mutations […] These results suggest the combination of ramucirumab plus erlotinib has the potential to be an important first-line treatment option for people with metastatic EGFR-mutated non-small cell lung cancer,” said Kazuhiko Nakagawa, MD, Department of Medical Oncology, Kindai University Faculty of Medicine, and global lead principal investigator of the RELAY trial.
Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist that is indicated to treat gastric cancer, colorectal cancer, non-small cell lung cancer, and hepatocellular carcinoma.
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