Metastatic Non-Small Cell Lung Cancer
REVEL trial: Objective response rate
Statistically significant improvement in ORR in the ITT population1
REVEL ORR: Percent of Patients (95% CI)1
- ORR=complete plus partial response; does not include stable disease. Disease progression and tumor response were assessed by investigators in accordance with RECIST 1.12
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.
ORR results for CYRAMZA were consistent between the ITT population and patients with rapidly progressing disease* when added to docetaxel1,3
Post hoc exploratory subgroup analyses: Patients with rapid progression* on initial platinum-based therapy (≤12 weeks; n=209)3
REVEL Subgroup ORR: Percentage of Patients (95% CI)3
REVEL Exploratory Analyses2,3,4
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.