REVEL trial overview
REVEL: A pivotal phase III trial in patients with mNSCLC (nonsquamous or squamous histologies) with disease progression on or after platinum-based therapy (N=1253)1
REVEL Trial Design1,2
A large, multinational, randomized, double-blind, placebo-controlled trial in patients with disease progression on or after one platinum-based therapy for locally advanced or metastatic disease1
Major Efficacy Outcome Measure: Overall Survival (OS)
Supportive Efficacy Outcome Measures: Progression-Free Survival (PFS), Overall Response Rate (ORR)
- Patients received treatment until disease progression, unacceptable toxicity, withdrawal, or death3
Approximately 1 in 6 patients in the REVEL trial had rapidly progressing disease‡4
REVEL: Post Hoc Exploratory Subgroup Analysis in Patients with Rapidly Progressing Disease‡ on Initial Platinum-based Therapy4
REVEL Exploratory Analyses3-5:
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.
SELECT IMPORTANT SAFETY INFORMATION
- CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Across five clinical studies in 1916 patients with various cancers treated with CYRAMZA, the incidence of all Grade and Grade 3-5 gastrointestinal perforations ranged from <1-2%.
- Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.
REVEL population highlights (N=1253)1
- Patients who discontinued combination therapy because of an adverse event attributed to either CYRAMZA or docetaxel were permitted to continue monotherapy with the other treatment component until disease progression or intolerable toxicity1
- Tumor EGFR status was unknown for the majority of patients (65%). Where tumor EGFR status was known (n=445), 7.5% were positive for EGFR mutation (n=33)1
- No data were collected regarding tumor ALK rearrangement status1