REVEL trial: Progression-free Survival
Statistically significant delay in disease progression in the ITT population1
Half of patients who received CYRAMZA in combination with docetaxel achieved an
estimated 4.5 months or longer PFS vs 3.0 months or longer for docetaxel alone1
SUPPORTIVE OUTCOME MEASURE
PROGRESSION-FREE SURVIVAL: MEDIAN – MONTHS (95% CI)1
CI=confidence interval; PFS=progression-free survival.
- The percentage of events at the time of analysis was 89% (558 patients) and 93% (583 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
PFS results were consistent between the ITT population and patients with aggressive disease*1
EXPLORATORY SUBGROUP ANALYSIS: PATIENTS WITH REFRACTORY DISEASE (n=360)
PROGRESSION-FREE SURVIVAL: Median—Months (95% CI)1
CI=confidence interval; OS=overall survival.
- The percentage of events at the time of analysis in the CYRAMZA plus docetaxel arm was 88% (156 patients) and 92% (168 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