RELAY+: Final Overall Survival With Ramucirumab Plus Gefitinib in Patients With Untreated EGFR-Mutated Metastatic NSCLC.

INTRODUCTION

Ramucirumab (RAM) plus gefitinib (GEF) exhibited favorable efficacy and safety as first-line treatment in the primary analysis of the RELAY+ study of East Asian patients with metastatic EGFR-mutated NSCLC. We report the final overall survival (OS) and safety.

METHODS

This open-label, two-period, single-arm exploratory study included patients with untreated NSCLC having EGFR ex19del or L858R mutations and no central nervous system metastasis or EGFR T790M mutation. Patients received RAM (10 mg/kg every 2 wk) plus GEF (250 mg once daily) until disease progression (period 1); patients with disease progression who acquired a T790M mutation received RAM plus osimertinib (80 mg once daily) (period 2).

RESULTS

At final OS data cutoff (October 20, 2023; median follow-up: 42.5 mo), median (95% confidence interval [CI]) OS was 47.4 (35.9‒57.6) months, and the 3-year OS rate was 61.8%. In the L858R and ex19del subgroups, median OS was 51.9 and 38.4 months, and 3-year OS rates were 70.2% and 52.8%, respectively. Overall, 85.4% of patients received subsequent systemic therapy post study treatment discontinuation. Grade 3 or higher treatment-related adverse events (AEs) were reported by 51 (62.2%) patients. The most common grade 3 or higher treatment-emergent AE of special interest was hypertension (25.6%; grade 3 event only). Treatment-emergent T790M rate post progression was 81.3%.

CONCLUSIONS

RELAY+ revealed a favorable benefit-risk profile for RAM plus GEF in East Asian patients with untreated EGFR-mutated metastatic NSCLC, supporting RAM plus GEF as an alternative first-line treatment option, particularly in those with an L858R mutation.