Metastatic Non-Small Cell Lung Cancer
REVEL trial: Progression-free survival
Statistically significant delay in disease progression in the ITT population1
Half of patients who received CYRAMZA + docetaxel achieved an estimated PFS of 4.5 months or longer vs 3.0 months or longer with docetaxel alone1
REVEL PFS: Median—Months (95% CI)1
- The percentage of events at the time of analysis was 89% (558 patients) and 93% (583 patients) in the CYRAMZA + docetaxel and placebo + docetaxel arms, respectively1
- 126 of 558 events in CYRAMZA-treated patients and 109 of 583 events in placebo-treated patients were deaths1
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.
PFS results for CYRAMZA were consistent between the ITT population and patients with rapidly progressing disease* when added to docetaxel1,2
Post hoc exploratory subgroup analysis: Patients with rapid progression* on initial platinum-based therapy (≤12 weeks; n=209)2
REVEL Subgroup PFS: Median—Months (95% CI)2,3
- The percentage of events at the time of analysis in the CYRAMZA + docetaxel arm was 91% (101 patients) and 92.9% (91 patients) in the placebo + docetaxel arm2,4
REVEL Exploratory Analyses2,5,6
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.