Metastatic Non-Small Cell Lung Cancer
REVEL trial: Overall response rate (ORR)
Statistically significant improvement in ORR in the ITT population1
REVEL ORR: Percent of Patients (95% CI)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 1.12
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.
SELECT IMPORTANT SAFETY INFORMATION
- An increased incidence of severe hypertension occurred in patients receiving CYRAMZA. Across five clinical studies in 1916 patients with various cancers treated with CYRAMZA, the incidence of all Grade hypertension occurred between 11-26%. Grade 3-5 hypertension incidence ranged from 6-15%.
- Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every two weeks or more frequently as indicated during treatment. Withhold CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA for medically significant hypertension that cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.
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.