Table 3.
Efficacy data.
| Study name | Approval trial? | Primary endpoint | Median OS gains in months | OS HR (95% CI) | Median PFS gains in months | PFS HR (95% CI) | QOL outcomes reported? | QOL outcomes improved? | ESMO-MCBS scorea |
|---|---|---|---|---|---|---|---|---|---|
| REGARD | Yes | OS | 1.4 m (5.2 v 3.8) | 0.78(0.60–0.99) | 0.8 m (2.1 v 1.3) | 0.48(0.38–0.62) | Yes | No | 1 |
| RAINFALL | No | PFS | 0.5 m (11.2 v 10.7) | 0.96(0.80–1.16) | 0.3 m (5.7 v 5.4) | 0.75 (0.61–0.94) | Yes | No | NA |
| REVEL | Yes | OS | 1.4 m (10.5 v 9.1) | 0.86(0.75–0.98) | 1.5 m (4.5 v 3.0) | 0.76(0.68–0.86) | Yes | No | 1 |
| ROSE/TRIO-012 | No | PFS | 0.1 m (27.3 v 27.2) | 1.01(0.83–1.23) | 1.3 m (9.5 v 8.2) | 0.88(0.75–1.01) | Yes | No | NA |
| RANGE | No | PFS | 1.5 m (9.4 v 7.9) | 0.89(0.72–1.09) | 1.3 m (4.1 v 2.8) | 0.76(0.61–0.94) | Yes | No | NA |
| RAISE | Yes | OS | 1.6 m (13.3 v 11.7) | 0.84(0.73–0.97) | 1.2 m (5.7 v 4.5) | 0.79(0.69–0.90) | Yes | No | 1 |
| RAINBOW | Yes | OS | 2.2 m (9.6 v 7.4) | 0.81(0.68–0.96) | 1.5 m (4.4 v 2.9) | 0.64(0.54–0.75) | Yes | No | 2 |
| REACH | No | OS | 1.6 m (9.2 v 7.6) | 0.87(0.72–1.05) | 0.7 m (2.8 v 2.1) | 0.63(0.52–0.75) | No | NA | NA |
| REACH-2 | Yes | OS | 1.2 m (8.5 v 7.3) | 0.71(0.53–0.95) | 1.2 m (2.8 v 1.6) | 0.45(0.34–0.60) | No | NA | 1 |
| RELAY | Yes | PFS | NA (Not reached in both arms) | 0.83(0.53–1.30) | 7 m (19.4 v 12.4) | 0.59(0.46–0.76) | No | NA | 3 |
OS: Overall survival, PFS: Progression-free survival, HR: Hazard Ratio, CI: confidence interval, ESMO-MCBS: European Society for Medical Oncology-Magnitude of Clinical Benefit Scale, NA: Not applicable; QOL: Quality of Life. Median OS gains = median OS in ramucirumab arm minus median OS in the control arm; median PFS gains = median PFS in ramucirumab arm minus median PFS in the control arm. m = months.
a
ESMO MCBS Scores are calculated only for approved indications to facilitate evaluation of magnitude of clinical benefit for the given drug for the given indication.