Metastatic Non-Small Cell Lung Cancer
REVEL trial: Overall survival
Statistically significant improvement in OS in the ITT population1
REVEL Major Outcome Measure - OS: Median - Months (95% CI)1
- The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA + docetaxel and placebo + docetaxel arms, respectively1
REVEL Trial Design (N=1253)1
The phase III REVEL trial evaluated the efficacy and safety of CYRAMZA plus docetaxel vs placebo plus docetaxel in patients with mNSCLC with disease progression on or after platinum-based chemotherapy. Major efficacy outcome measure was OS. Supportive efficacy outcome measures were PFS and ORR. All patients were required to have ECOG PS 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.
OS results for CYRAMZA were consistent between the ITT population and patients with rapidly progressing disease* when added to docetaxel1,3
Post hoc exploratory subgroup analysis: Patients with rapid progression* on initial platinum-based therapy (≤12 weeks; n=209)3
REVEL Subgroup OS: Median—Months (95% CI)3
- The percentage of deaths at the time of analysis in the CYRAMZA + docetaxel arm was 75.7% (84 patients) and 80.6% (79 patients) in the placebo + docetaxel arm3,5
REVEL Exploratory Analyses3,6,7
The REVEL trial was not adequately powered or error-controlled for subgroup analyses. Treatment differences observed in these subgroups cannot be regarded as statistically significant. The analyses described here were post hoc and exploratory.