RELAY: safety and efficacy of ramucirumab plus erlotinib in elderly Japanese patients with metastatic EGFR-mutated NSCLC

Abstract

Aim: The global phase III RELAY trial demonstrated the efficacy of ramucirumab (RAM) plus erlotinib (ERL) in patients with untreated metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). We present safety and efficacy profiles of RAM+ERL in Japanese elderly (aged ≥ 75 years) patients in RELAY. Methods: Patients were randomized (1:1) to RAM (10 mg/kg) or placebo (PL) intravenously every 2 weeks plus 150 mg/day ERL orally. Primary endpoint was progression-free survival (reported elsewhere). This report describes response rates, study drug exposure, dose adjustments, safety, and post-study treatment discontinuation therapies in Japanese elderly patients (RAM+ERL, n = 12; PL+ERL, n = 17). Results: Overall response rate was similar in RAM+ERL (83.3%) and PL+ERL (82.4%) arms. Median treatment duration of RAM and ERL was 6.0 and 15.4 months, respectively. Most patients had RAM and/or ERL dose adjustments. Adverse events, including grade ≥ 3 events, were similar in both treatment arms, although proteinuria occurred exclusively in the RAM+ERL arm (six patients; no grade ≥ 3 events). All patients received subsequent therapy after first-line study treatment; various subsequent therapies were used. Conclusion: These results suggest that RAM+ERL may be a suitable first-line treatment option for elderly patients with EGFR-mutated NSCLC. Clinical trial registration: www.clinicaltrials.gov identifier is NCT02411448.