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)
The phase III REVEL trial evaluated the efficacy and safety of CYRAMZA plus docetaxel vs placebo plus docetaxel in patients with locally advanced or 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 overall 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.
SELECT IMPORTANT SAFETY INFORMATION
Arterial Thromboembolic Events (ATEs)
- Serious, sometimes fatal, ATEs, including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia, occurred across clinical trials. In 2137 patients with various cancers treated with CYRAMZA, the incidence of all Grade ATE was 1-3%. Grade 3-5 ATE incidence was <1-2%.
- Permanently discontinue CYRAMZA in patients who experience an ATE.
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.