REVEL trial overview
REVEL: A pivotal phase III trial in patients with metastatic NSCLC (nonsquamous or squamous histologies) with disease progression on or after platinum-based therapy (N=1253)1
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
REVEL TRIAL DESIGN1,2
ECOG=Eastern Cooperative Oncology Group; PS=performance status; IV=intravenous.
*Stratification factors: Geographic region, ECOG PS, prior maintenance therapy, and gender.
†24 patients at East Asian sites received a starting dose of docetaxel at 60 mg/m2 every 3 weeks.
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
REVEL: EXPLORATORY SUBGROUP ANALYSIS IN PATIENTS WITH AGGRESSIVE DISEASE‡4
Similar to the ITT population, the percentage of patients with ECOG PS 1 in the refractory subgroup were balanced between treatment arms1,4
‡Aggressive disease is defined by those patients who were primary refractory to platinum-based therapy or who experienced limited time on initial platinum-based therapy (≤8 or ≤12 weeks).4
REVEL EXPLORATORY ANALYSES4,5:
The REVEL trial was not powered for subgroup analyses, nor were any such analyses error-controlled. The primary platinum-refractory population was a pre-specified subgroup in the REVEL trial; however, the subgroup of patients with limited time on initial platinum-based therapy (≤8 or ≤12 weeks) was not pre-specified. Each subgroup analysis presented was exploratory. Kaplan-Meier estimates and Cox regression analyses of OS and PFS were performed for all subgroups. The Cochran-Mantel-Haenszel test assessed differences in ORR between treatment groups. Safety analyses were performed on both subsets of patients from the safety population, defined as all patients who had received at least one dose of study drug.
REVEL population highlights1
REVEL POPULATION HIGHLIGHTS (N=1253)1
|Most common prior therapies|
|Prior maintenance therapy|
|Patients who received prior maintenance||22%|
- 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 treatment arms1
DEMOGRAPHICS AND BASELINE CHARACTERISTICS2
|CYRAMZA + docetaxel (n=628)||Placebo + docetaxel (n=625)|
|Age, median (range)||62 (21-85)||61 (25-86)|
ECOG=Eastern Cooperative Oncology Group; PS=performance status.
*Data not available for one patient in the CYRAMZA plus docetaxel group.
†Data not available for one patient in each group.