Age Subgroup Analysis Of Efficacy And Safety Data From Two Phase 3 Studies Of Second-Line Ramucirumab (Ram) Versus Placebo (Pl) In Patients (Pts) With Previously Treated Gastric Or Gastroesophageal Junction (Gej) Adenocarcinoma (Rainbow And Regard)

Background: From 2009–2012, 1020 pts with metastatic gastric or GEJ adenocarcinoma were enrolled in two phase 3, randomized, double-blind studies of RAM following progressive disease on first-line platinum- and/or fluoropyrimidine-containing combination therapy: the RAINBOW and REGARD studies.Methods: In RAINBOW, 665 pts were randomized to RAM (8mg/kg) + paclitaxel (PTX; 80 mg/m2) vs PL + PTX; in REGARD, 355 pts were randomized to RAM (8 mg/kg) + best supportive care (BSC) vs PL + BSC. We examined outcomes by age (<65 and ≥65 years [y]). Overall survival (OS) was the primary endpoint; secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety.Results: In RAINBOW, 416 pts were aged <65y and 249 were ≥65y. In REGARD, 227 pts were <65y and 128 were ≥65y. Outcomes are summarized in the Table; RAM efficacy was similar in younger and older patients in both studies. The incidence of Grade ≥3 adverse events in RAINBOW was higher in the RAM + PTX arm for both age groups and similar across age groups. The incidence of Grade ≥3 adverse events (AE) in REGARD was similar between treatment arms for both age groups (see Table).Table: L01*StudyRainbowRegardAge group<65 years≥65 years<65 years≥65 yearsMedian age (range)56 (25–64)70 (65–84)54 (24–64)71 (65–87)Treatment ArmsRAM + PTXPL + PTXRAM + PTXPL + PTXRAM + BSCPL + BSCRAM + BSCPL + BSCN204212126123156718246Outcome MeasuresMedian OS (m)9.37.110.78.75.34.15.23.8HR (95% CI)0.753 (0.604–0.939)0.861 (0.636–1.165)0.846 (0.611–1.171)0.722 (0.471–1.106)p value for interaction0.370.18Median PFS (m)4.32.84.62.91.91.32.81.4HR (95% CI)0.572 (0.460–0.711)0.673 (0.506–0.894)0.450 (0.327–0.620)0.490 (0.319–0.752)p value for interaction0.560.94ORR28%14%27%20%NANANANASafetyGrade ≥3 adverse event incidence79%64%85%60%55%57%60%60%NA, data not available. Open table in a new tab Background: From 2009–2012, 1020 pts with metastatic gastric or GEJ adenocarcinoma were enrolled in two phase 3, randomized, double-blind studies of RAM following progressive disease on first-line platinum- and/or fluoropyrimidine-containing combination therapy: the RAINBOW and REGARD studies. Methods: In RAINBOW, 665 pts were randomized to RAM (8mg/kg) + paclitaxel (PTX; 80 mg/m2) vs PL + PTX; in REGARD, 355 pts were randomized to RAM (8 mg/kg) + best supportive care (BSC) vs PL + BSC. We examined outcomes by age (<65 and ≥65 years [y]). Overall survival (OS) was the primary endpoint; secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Results: In RAINBOW, 416 pts were aged <65y and 249 were ≥65y. In REGARD, 227 pts were <65y and 128 were ≥65y. Outcomes are summarized in the Table; RAM efficacy was similar in younger and older patients in both studies. The incidence of Grade ≥3 adverse events in RAINBOW was higher in the RAM + PTX arm for both age groups and similar across age groups. The incidence of Grade ≥3 adverse events (AE) in REGARD was similar between treatment arms for both age groups (see Table). NA, data not available.