Table 2.
Summary of efficacy in phase II and III studies of ramucirumab in advanced gastric and gastroesophageal junction cancer
| Author | Trial design/Setting | No. of patients | Treatment | Primary endpoint | OS | PFS/TTP | ORR |
|---|---|---|---|---|---|---|---|
| Fuchs et al. (REGARD) [21] | Phase III, randomized, double-blind, placebo-controlled/2nd-line | 355 | Ramucirumab vs. placebo | OS | Ramucirumab 5.2 mo vs. placebo 3.8 mo: | Ramucirumab 2.1 mo vs placebo 1.3 mo: | Ramucirumab 3% vs. placebo 3%: |
| HR 0.776 | HR 0.483 | p=0.76 | |||||
| 95% CI 0.60-1.00 | 95% CI 0.38-0.62 | ||||||
| p=0.047 | p < 0.0001 | ||||||
| Wilke et al. (RAINBOW) [22] | Phase III, randomized, double-blind, placebo-controlled/2nd-line | 665 | Ramucirumab+paclitaxel vs. placebo+paclitaxel | OS | Ramucirumab+paclitaxel 9.6 mo vs. placebo+paclitaxel 7.4 mo: | Ramucirumab+paclitaxel 4.4 mo vs. placebo+paclitaxel 2.9 mo: | Ramucirumab+paclitaxel 28% vs. placebo+paclitaxel 16%: |
| HR 0.807 | HR 0.635 | p=0.0001 | |||||
| 95% CI 0.68-0.96 | 95% CI 0.54-0.75 | ||||||
| p=0.017 | p < 0.0001 | ||||||
| Yoon et al. [23] | Phase II, randomized, double-blind, placebo-controlled/1st-line | 168 | Ramucirumab+FOLFOX vs. placebo+FOLFOX | PFS | Ramucirumab+FOLFOX 11.7 mo vs. placebo+FOLFOX 11.5 mo: | Ramucirumab+FOLFOX 6.4 mo vs. placebo+FOLFOX 6.7 mo: | Ramucirumab+FOLFOX 45% vs. placebo+FOLFOX 46% |
| HR 1.08 | HR 0.98 | ||||||
| 95% CI 0.73-1.58 | 95% CI 0.69-1.37 | ||||||
| p=0.89 |
OS, overall survival (median); PFS, progression-free survival (median); TTP, time to progression (median); ORR, objective response rate; HR, hazard ratio; CI, confidence interval; FOLFOX, folinic acid, 5-fluorouracil, and oxaliplatin.