Metastatic Non-Small Cell Lung Cancer
REVEL trial: Overall response rate (ORR)
Statistically significant improvement in ORR 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 ORR: Percentage of Patients (95% CI)1*
REVEL Trial Design (N=1253)
The phase III REVEL trial evaluated the efficacy and safety of CYRAMZA plus docetaxel vs placebo plus docetaxel in patients with locally advanced or 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 overall 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.
A 64% DCR was observed with CYRAMZA + docetaxel in the ITT population3
Supportive Outcome Measure: DCR - Percentage of Patients (95% CI)‡
Disease Control Rate (DCR) was a pre-specified secondary endpoint. The DCR analysis was not controlled for type 1 error and therefore treatment differences cannot be regarded as statistically significant.
SELECT IMPORTANT SAFETY INFORMATION
- IRR, including severe and lifethreatening IRR, occurred in CYRAMZA clinical trials. Symptoms of IRR included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. In 2137 patients with various cancers treated with CYRAMZA in which premedication was recommended or required, the incidence of all Grade IRR ranged from <1- 9%. Grade 3-5 IRR incidence was <1%.
- Premedicate prior to each CYRAMZA infusion. Monitor patients during the infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Reduce the infusion rate by 50% for Grade 1-2 IRR. Permanently discontinue CYRAMZA for Grade 3- 4 IRR.
ORR results for CYRAMZA were consistent between the ITT population and patients with rapidly progressing disease§ when added to docetaxel1,4
Post hoc exploratory subgroup analyses: Patients with rapid progression§ on initial platinum-based therapy (≤12 weeks; n=209)4
REVEL Subgroup ORR: Percentage of Patients (95% CI)4
REVEL EXPLORATORY ANALYSIS2,4,5:
The REVEL trial was not adequately powered or 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.
A 49.5% DCR was observed with CYRAMZA + docetaxel in the rapidly progressing‖ population6
DCR - Percentage of Patients (95% CI)6
SELECT IMPORTANT SAFETY INFORMATION
Worsening of Preexisting Hepatic Impairment
- Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome, was reported in patients with Child-Pugh B or C cirrhosis who received single agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.
- Based on safety data from REACH-2, in patients with Child-Pugh A liver cirrhosis, the pooled incidence of hepatic encephalopathy and hepatorenal syndrome was higher for patients who received CYRAMZA (6%) compared to patients who received placebo (0%).
Watch video: REVEL trial outcomes in patients with rapid progression
CI=confidence interval; CR=complete response; DCR=disease control rate; ECOG=Eastern Cooperative Oncology Group; ITT=intent-to-treat; mNSCLC=metastatic non-small cell lung cancer; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response; PS=performance status; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease.