REGARD trial: Efficacy overview
CYRAMZA monotherapy significantly extended overall survival1
REGARD OVERALL SURVIVAL: MEDIAN – MONTHS (95% CI)1
MAJOR OUTCOME MEASURE
CI=confidence interval; OS=overall survival.
- The percentage of deaths at the time of analysis was 75% (179 patients) and 85% (99 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