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.
SELECT IMPORTANT SAFETY INFORMATION
IMPAIRED WOUND HEALING
- Impaired wound healing can occur in patients who receive drugs that inhibit the VEGF or VEGFR pathway. CYRAMZA, a VEGFR2 antagonist, has the potential to adversely affect wound healing. CYRAMZA has not been studied in patients with serious or non-healing wounds.
- Withhold CYRAMZA for 28 days prior to elective surgery. Do not administer CYRAMZA for at least 28 days following a major surgical procedure and until the wound is fully healed. Discontinue CYRAMZA in patients who develop wound healing complications that require medical intervention.
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.