Metastatic Non-Small Cell Lung Cancer
REVEL trial: Progression-free survival
Statistically significant delay in disease progression in the ITT population1
Half of patients who received CYRAMZA + docetaxel achieved an estimated PFS of 4.5 months or longer vs 3.0 months or longer with docetaxel alone1
REVEL PFS: Median—Months (95% CI)1
- The percentage of events at the time of analysis was 89% (558 patients) and 93% (583 patients) in the CYRAMZA + docetaxel and placebo + docetaxel arms, respectively1
- 126 of 558 events in CYRAMZA-treated patients and 109 of 583 events in placebo-treated patients were deaths1
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
ARTERIAL THROMBOEMBOLIC EVENTS
- Serious, sometimes fatal, arterial thromboembolic events (ATEs), including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia, occurred across clinical trials. Across five clinical studies in 1916 patients with various cancers treated with CYRAMZA, the incidence of all Grade ATE was 2-3%. Grade 3-5 ATE incidence was 1-2%.
- Permanently discontinue CYRAMZA in patients who experience an ATE.
PFS results for CYRAMZA were consistent between the ITT population and patients with rapidly progressing disease* when added to docetaxel1,2
Post hoc exploratory subgroup analysis: Patients with rapid progression* on initial platinum-based therapy (≤12 weeks; n=209)2
REVEL Subgroup PFS: Median—Months (95% CI)2,3
- The percentage of events at the time of analysis in the CYRAMZA + docetaxel arm was 91% (101 patients) and 92.9% (91 patients) in the placebo + docetaxel arm2,4
REVEL Exploratory Analyses2,5,6
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.