
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
*Stratification factors: Geographic region, ECOG PS, prior maintenance therapy, and gender.1
†24 patients at East Asian sites received a starting dose of docetaxel at 60 mg/m2 every 3 weeks.1
Major Efficacy Outcome Measure: Overall Survival (OS)
Supportive Efficacy Outcome Measures: Progression-Free Survival (PFS), Objective 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.
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
Demographics and baseline characteristics were similar between the ITT population and rapid progression‡ subgroup1,3,4,6
ITT Population: Demographics and Baseline Characteristics3,7

§Data not available for 1 patient in the CYRAMZA plus docetaxel group.1,3
ǁData not available for 1 patient in each group.1,3
Demographics and Baseline Characteristics: Patients with Rapidly Progressing Disease‡ ≤12 Weeks (n=209)4

‡Rapidly progressing disease is defined as time to progression within 9 or 12 weeks after starting initial platinum-based treatment.4
ALK=anaplastic lymphoma kinase; CR=complete response; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; ITT=intent-to-treat; IV=intravenous; mNSCLC=metastatic non-small cell lung cancer; ORR=objective response rate; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PR=partial response; PS=performance status; SD=stable disease.
References: 1. CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017. 2. Supplement to: Garon EB, Ciuleanu T-E, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. 3. Garon EB, Ciuleanu T-E, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. 4. Reck M, Shepherd F, Pérol M, et al. Effects of second-line ramucirumab after rapid time to progression on first-line therapy: subgroup analysis of REVEL in advanced non-small cell lung cancer. Oral presentation presented at: IASLC 18th World Conference on Lung Cancer; October 15-18, 2017; Yokohama, Japan. 5. Data on File, Lilly USA, LLC, DOF-RB-US-0006. 6. Data on file. Eli Lilly and Company. ONC20170503b. 7. Data on file. Eli Lilly and Company. ONC20170511A.