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 were consistent between the ITT population and patients with aggressive disease*1
EXPLORATORY SUBGROUP ANALYSIS: PATIENTS WITH REFRACTORY DISEASE (n=360)
OBJECTIVE RESPONSE RATE: PERCENT OF PATIENTS (95% CI)†1
REVEL EXPLORATORY ANALYSES1,2
The REVEL trial was not adequately powered, nor error-controlled, for subgroup analyses. Treatment differences observed in these subgroups cannot be regarded as statistically significant. The analyses described here were exploratory.
*Aggressive disease is defined by those patients who were primary refractory to platinum-based therapy or who experienced limited time on initial platinum-based therapy (≤8 or ≤12 weeks).1
†Disease progression and tumor response were assessed by investigators in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.3