RELAY+: Exploratory study of ramucirumab plus gefitinib in untreated patients (pts) with epidermal growth factor receptor (EGFR)-mutated metastatic non-small cell lung cancer (NSCLC)
Abstract No : 9564
Abstract Type : Poster Session
Indication : EGFR mutated NSCLC
Intervention : Ramucirumab plus gefitinib
Company : Eli Lilly and Company
Technology : Monoclonal antibody
In total, 82 pts were enrolled (Japan: 68; Taiwan: 8; Korea: 6); 65.9% were female, 65.9% were never-smokers, and 43.9% had Ex19del. With median follow-up of 13.8 months (range: 2.6–20.2; censoring rate: 58.5%), the overall 1-year PFS rate (95% CI) was 65.0% (52.4–75.1), 67.2% (48.6–80.3) in pts with Ex19del (n=36), and 63.4% (45.0–77.1) in pts with Ex21.L858R (n=46). The objective response rate was 70.7% (95% CI: 59.6–80.3), disease control rate was 98.8% (95% CI: 93.4–100.0), and duration of response was immature at this point in time with a censoring rate of 56.9% where the median point estimate was 13.6 months (95% CI: 11.1–18.2). Post-progression EGFR T790M was seen in 7 of 9 (78%; 95% CI: 45.3–93.7) pts with 30- day follow-up NGS results in which EGFR activating mutation was detected. Grade $3 treatmentemergent adverse events reported in .5% of pts were ALT increased (23.2%), hypertension (22.0%), and AST increased (12.2%).
With a 1-year PFS rate of 65.0%, the primary endpoint of RELAY+ was met. The efficacy of RAM+GEF in RELAY+ was similar to that of RAM+ERL in RELAY, and the safety profile of the combination was similar to that of the individual drugs.
1 year PFS (i.e. 65%), ORR (i.e. 71%) and DCR (i.e. 99%) were comparable between RAM+GEF in this study and RAM+ERL in RELAY which supports its usage in first line EGFR mutated NSCLC setting