
Advanced gastric or GEJ adenocarcinoma
Clinical trial design: REGARD
REGARD: The pivotal phase III trial for CYRAMZA monotherapy (N=355)1
A multicenter, randomized, placebo-controlled, double-blind trial of patients with locally advanced or metastatic gastric or GEJ adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy*
REGARD TRIAL DESIGN1

- Major Efficacy Outcome Measure: Overall survival.
- Supportive Efficacy Outcome Measure: Progression-free survival.
- The REGARD trial did not include or exclude patients based on any specific biomarker2
*Patients received prior platinum/fluoropyrimidine combination therapy (81%), fluoropyrimidine-containing regimens without platinum (15%), or platinum-containing regimens without fluoropyrimidine (4%).
†85% of patients received prior first-line chemotherapy for metastatic disease and 15% received prior adjuvant chemotherapy.
‡Stratification factors: Weight loss over prior 3 months (≥10% vs <10%), geographic region, and location of primary tumor.
REGARD: Demographic and baseline characteristics were similar between treatment arms1,3
REGARD: Demographic and baseline characteristics3

REGARD: All patients received prior fluoropyrimidine- or platinum-containing chemotherapy1
REGARD: Prior chemotherapy1

Chemotherapy administered prior to REGARD trial enrollment included a number of different regimens4
REGARD: Prior chemotherapy regimens across treatment arms4

BSC=best supportive care; ECOG=Eastern Cooperative Oncology Group; GEJ=gastroesophageal junction; PS=performance status.
References: 1. CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017. 2. Supplement to: Fuchs CS, Tomasek J, Yong CJ, et al; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phased 3 trial. Lancet.2014;383:31-39. 3. Fuchs CS, Tomasek J, Yong CJ, et al; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phased 3 trial. Lancet. 2014;383:31-39. 4. Data on file, Eli Lilly and Company. ONC20140731a.