REGARD trial overview
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
ECOG=Eastern Cooperative Oncology Group; PS=performance status; BSC=best supportive care.
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.