Patients with disease progression on or after platinum-based therapy have a high unmet need for options that can extend survival*1
Not all patients with mNSCLC progress at the same rate.1
There are some patients who know their situation but are not surrendering to it.
- Rapidly progressing disease† (≤12 weeks) on platinum-based treatment1
- ECOG PS 0 or 12
- Non-squamous or squamous histology2
- Disease progression on platinum-based therapy (ie, 20% growth as defined per RECIST criteria)2,3
- Increase in number of metastatic lesions2,3
- No contraindications for antiangiogenic therapy2
Can you picture one of your patients?
ITT Population (N=1253)2
Major Outcome Measure - OS: Median
- CYRAMZA + docetaxel (n=628): 10.5 months (95% CI: 9.5, 11.2)2
- Placebo + docetaxel (n=625): 9.1 months (95% CI: 8.4, 10.0)2
- HR=0.86 (95% CI: 0.75, 0.98; P=0.024)2
- 1.4-month survival difference2
- The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA + docetaxel and placebo + docetaxel arms, respectively.
SELECT IMPORTANT SAFETY INFORMATION
- CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including Grade ≥3 hemorrhagic events. In 2137 patients with various cancers treated with CYRAMZA, the incidence of all Grade hemorrhage ranged from 13-55%. Grade 3-5 hemorrhage incidence ranged from 2-5%.
- Patients with NSCLC receiving therapeutic anticoagulation or with evidence of major airway invasion by cancer were excluded from REVEL. In addition, patients with NSCLC with a recent history of gross hemoptysis, those receiving chronic therapy with NSAIDs or other anti-platelet therapy other than once daily aspirin or with radiographic evidence of major airway or blood vessel invasion or intratumor cavitation were excluded from REVEL and RELAY; therefore the risk of pulmonary hemorrhage in these groups of patients is unknown.
- Permanently discontinue CYRAMZA in patients who experience severe (Grade 3 or 4) bleeding.
OS, PFS, and ORR results for CYRAMZA were consistent between the ITT population and patients with rapidly progressing disease† when added to docetaxel1,2
†Rapidly progressing disease is defined as time to progression within 12 weeks after starting initial platinum-based treatment.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 1.1.2
§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, respectively.2
ǁ126 of 558 events in CYRAMZA-treated patients and 109 of 583 events in placebo-treated patients were deaths.2
¶The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA + docetaxel and placebo + docetaxel arms, respectively.2
#The percentage of deaths at the time of analysis in the CYRAMZA + docetaxel arm was 75.7% (84 patients) and 80.6% (79 patients) in the placebo + docetaxel arm.1,6
**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 arm.1,6
REVEL Exploratory Analyses1,5,7
The REVEL trial was not adequately powered or error-controlled for subgroup analysis. Treatment differences observed in these subgroups cannot be regarded as statistically significant. The analysis described here were post hoc and exploratory.
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.
††24 patients of East Asian sites received a starting dose of docetaxel at 60 mg/m2 every 3 weeks.
SELECT IMPORTANT SAFETY INFORMATION
- CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. In 2137 patients with various cancers treated with CYRAMZA, the incidence of all Grade and Grade 3-5 gastrointestinal perforations ranged from <1-2%.
- Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.
Watch Video: REVEL trial efficacy in ITT population
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Recommend ramucirumab (CYRAMZA) in combination with docetaxel (category 2A) as an option for metastatic NSCLC8
NCCN Guidelines® for mNSCLC recommend ramucirumab (CYRAMZA) in combination with docetaxel as a subsequent treatment option (category 2A) for metastatic NSCLC‡‡. Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.8