Addition of Ramucirumab to Erlotinib Did Not Significantly Improve Overall Survival for Patients With EGFR-Mutated Non-Small Cell Lung Cancer
Final Overall Survival Results From the Phase 3 RELAY Trial
Final Overall Survival Results From the Phase 3 RELAY Trial
According to final overall survival (OS) results from the phase 3 RELAY trial, the addition of ramucirumab to erlotinib did not significantly improve OS among patients with previously untreated epidermal growth factor receptor (EGFR)-mutated metastatic non-small cell lung cancer (NSCLC).
This double-blind, placebo-controlled trial enrolled 449 patients with previously untreated EGFR exon 19 deletion or L858R-mutated metastatic NSCLC. Patients were randomized on a 1-to-1 basis to receive 150 mg of daily erlotinib plus either 10 mg/kg of twice weekly ramucirumab (n = 224) or placebo (n = 225). The end point for this analysis was OS in the intention-to-treat population. Previously reported results from this trial demonstrated a statistically significant improvement in progression-free survival among patients who received erlotinib plus ramucirumab.
At a median follow-up of 45.1 months, the median OS in the intention-to-treat population was 51.1 months in the ramucirumab arm and 46 months in the placebo arm (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.78 to 1.24; P = .864). The HR for OS was 0.87 among patients with L858R mutations, 1.13 among patients with exon 19 deletion mutations, 0.83 among patients with TP53 co-mutations, and 1.22 among patients with TP53 wild-type mutations. No new safety signals were observed and there was no increase in toxicity over time. Treatment-emergent T790M rates were similar in both treatment arms. Over 80% of patients received discontinuation therapy after the study concluded (>50% received osimertinib).
Study authors concluded “OS was not significantly improved with similar long OS durations in both treatment arms.”
Source:
Nakagawa K, Garon EB, Seto T, et al. RELAY: Final overall survival for erlotinib + ramucirumab or placebo in untreated, EGFR-mutated metastatic NSCLC. J Thorac Oncol. Published online: November 29, 2024. doi: 10.1016/j.jtho.2024.11.032
