Table 1.
Results from four phase-III clinical trials investigating front-line immune checkpoint inhibitor use in metastatic renal cell carcinoma.
| Trial | CheckMate-214 (Intermediate + Poor Risk Patients) | IMmotion-151 | JAVELIN-101 | KEYNOTE-426 | ||||
|---|---|---|---|---|---|---|---|---|
| Arms | Nivolumab + Ipilimumab | Sunitinib | Bevacizumab + Atezolizumab | Sunitinib | Axitinib + Avelumab | Sunitinib | Axitinib + Pembrolizumab | Sunitinib |
| Patients Enrolled | 425 | 422 | 454 | 461 | 442 | 444 | 432 | 429 |
| ORR, % (95% CI) | 42 (37–47) | 27 (22–31) | 37 (32–41) | 33 (29–38) | 51 (47–56) | 26 (22–30) | 59 (55–64) | 36 (31–40) |
| Median PFS | 11.6 | 8.4 | 11.2 | 8.4 | 13.8 | 8.4 | 15.1 | 11.1 |
| PFS HR (95% CI) | 0.82 (0.64–1.05) * | 0.83 (0.70–0.97) | 0.69 (0.56–0.84) | 0.69 (0.57–0.84) | ||||
| OS HR (95% CI) | 0.63 (0.44–0.89) † | 0.93 (0.76–1.14) | Not Reported | 0.53 (0.38–0.74) | ||||
| Grade 3/4 Adverse Events, % | 46 | 63 | 40 | 54 | 55 | 55 | 63 | 58 |
Abbreviations: ORR = overall response rate, CI = confidence interval, PFS = progression-free survival, HR = hazard ratio, OS = overall survival. * 99.1% confidence interval; † 99.8% confidence interval.