REVEL trial: Objective response rate
STATISTICALLY SIGNIFICANT IMPROVEMENT IN OBJECTIVE RESPONSE RATE IN THE ITT POPULATION1
OBJECTIVE RESPONSE RATE: PERCENT OF PATIENTS (95% CI)*1
SUPPORTIVE OUTCOME MEASURE
CI=confidence interval; ORR=objective response rate.
*Disease progression and tumor response were assessed by investigators in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.2
The phase III REVEL trial evaluated the efficacy and safety of CYRAMZA plus docetaxel vs placebo plus docetaxel in patients with metastatic NSCLC with disease progression on or after platinum-based chemotherapy. Major efficacy outcome measure was overall survival. Supportive efficacy outcome measures were progression-free survival and objective response rate. All patients were required to have Eastern Cooperative Oncology Group performance status 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.1
ORR results for CYRAMZA were consistent between the ITT population and patients with rapidly progressing disease when added to docetaxel*1
Exploratory Subgroup Analysis—Patients with rapid progression on initial platinum-based therapy (≤12 weeks)(n=209)
Objective Response Rate: Percent of Patients (95% CI)1
REVEL EXPLORATORY ANALYSIS2,3
The REVEL trial was not adequately powered, nor error-controlled, for subgroup analysis. Treatment differences observed in this subgroup cannot be regarded as statistically significant. The analysis described here was post-hoc and exploratory.
*Rapidly progressing disease is defined by time-to-progression within 9 or 12 weeks after starting initial platinum-based treatment.2,4