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. Across five clinical studies in 1916 patients with various cancers treated with CYRAMZA, the incidence of all Grade hemorrhage occurred between 13-44%. Grade 3-5 hemorrhage incidence ranged from 2-5%.
- Patients with NSCLC receiving therapeutic anticoagulation or 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; 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
REVEL Exploratory Analyses1,6,8
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.
REVEL Trial Design (N=1253)2
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.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Recommend ramucirumab (CYRAMZA) in combination with docetaxel (category 2A) as an option for metastatic NSCLC9
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.9