REGARD: PROGRESSION-FREE SURVIVAL:
MEDIAN – MONTHS (95% CI)1,2 SUPPORTIVE OUTCOME MEASURE
CI=confidence interval; PFS=progression-free survival.
- The percentage of events at the time of analysis was 84% (199 patients) and 92% (108 patients) in the CYRAMZA and placebo arms, respectively1
The phase III REGARD trial evaluated the efficacy and safety of CYRAMZA vs placebo in patients with locally advanced or metastatic gastric or GEJ adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Major efficacy outcome measure was overall survival. Supportive efficacy outcome measure was progression-free survival. All patients were Eastern Cooperative Oncology Group performance status 0 or 1. Prior to enrollment, 85% of patients had progressed during treatment or within 4 months after the last dose of first-line chemotherapy for metastatic disease, and 15% of patients progressed during treatment or within 6 months after the last dose of adjuvant chemotherapy. Patients were randomized 2:1 to CYRAMZA 8 mg/kg every 2 weeks plus best supportive care (BSC) (n=238) or placebo plus BSC (n=117).1
- CYRAMZA (ramucirumab) [package insert]. India, Eli Lilly & Company (India) Pvt. Ltd.
- 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, phase 3 trial. Lancet. 2014;383:31-39.