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
- ORR = complete response plus partial response. ORR does not include stable disease. Disease progression and tumor response were assessed by investigators in accordance with RECIST 1.1.2
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
Impaired Wound Healing
- CYRAMZA 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 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established.
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