REVEL Trial: Overall Survival
Statistically significant improvement in overall survival in the ITT population1
OVERALL SURVIVAL: MEDIAN – MONTHS (95% CI)1
MAJOR OUTCOME MEASURE
CI=confidence interval; ITT=intent-to-treat; OS=overall survival.
- The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA plus docetaxel and placebo plus docetaxel arms, respectively1
The phase III REVEL trial evaluated the efficacy and safety of CYRAMZA plus docetaxel vs placebo plus docetaxel in patients with metastatic NSCLC with disease progression on or after platinum-based chemotherapy. Major efficacy outcome measure was overall survival. Supportive efficacy outcome measures were progression-free survival and objective response rate. All patients were required to have Eastern Cooperative Oncology Group performance status 0 or 1. Patients were randomized 1:1 to receive either CYRAMZA 10 mg/kg (n=628) or placebo (n=625), in combination with docetaxel at 75 mg/m2 every 21 days.1
OS results were consistent between the ITT population and patients with aggressive disease*1
EXPLORATORY SUBGROUP ANALYSIS: PATIENTS WITH REFRACTORY DISEASE (n=360)
OVERALL SURVIVAL: Median—Months (95% CI)1
- The percentage of deaths at the time of analysis in the CYRAMZA plus docetaxel arm was 75% (134 patients) and 77% (141 patients) in the placebo plus docetaxel arm1
REVEL EXPLORATORY ANALYSES1,2
The REVEL trial was not adequately powered, nor error-controlled, for subgroup analyses. Treatment differences observed in these subgroups cannot be regarded as statistically significant. The analyses described here were exploratory.
*Aggressive disease is defined by those patients who were primary refractory to platinum-based therapy or who experienced limited time on initial platinum-based therapy (≤8 or ≤12 weeks).1