Table 2 Clinical trials of first-line therapies for metastatic kidney cancer
From: Increasing cure rates of solid tumors by immune checkpoint inhibitors
Trials | CheckMate 214 Nivolumab + Ipilimumab IV q3w X 4 then q4W | Keynote 426 Pembrolizumab + Axitinib 5–10 mg po bid | Javelin 101 Avelumab + Axitinib | CheckMate 9ER Nivolumab + Cabozantinib 40 mg po qd | CLEAR Pembrolizumab + Lenvatinib 20 mg po qd |
|---|---|---|---|---|---|
Number of Patients | 1096 | 861 | 886 | 651 | 1069 (3 arms) |
Primary endpoints | ORR, PFS and OS int/poor | OS and PFS | OS and PFS in PD-L1 +  | PFS | PFS, OS and safety |
ORR% (vs sunitinib %)CR% (vs sunitinib %) | 42 (vs 27) CR: 9 (vs 1) | 59.3 (vs 35.7) CR: 5.8 (vs 1.9) | 51.4 (vs 25.5) CR: 4.4 (vs 2.1) | 56 (vs 27) CR: 8 (vs 5) | 71.0 (vs 53.3%) (Len + evero) vs 36.1% (sunitinib) 16.1% vs 9.8% vs 4.2% |
OS hazard ratio | 0.66 (0.53–0.82) | 0.53 (0.38–0.74) | 0.78 (0.55–1.08) | 0.60 (0.40–0.89) | 0.66 (0.49–0.88) |
PFS (months) vs sunitinib | 12.4 vs 12.3 HR: 0.98 (0.79–1.23) | 15.1 vs 11.1 HR: 0.69 (0.57–0.84) | 13.8 vs 8.0 HR: 0.69 (0.56–0.83) | 16.6 vs 8.3 HR: 0.51 (0.41–0.64) | 23.9 vs 14.7 vs 9.2 HR: 0.39 |
Grade 3 and 4 toxicity % (sunitinib %) | 46 (vs 63) | 62.9 (vs 58) | 71.2 (vs 71.5) | 61 (vs 51) | 82.4 vs 83.1 vs 71.8 |
Toxicity-induced discontinuation % (sunitinib %) | 22 (vs 12) | 10.7 (vs 13.9) | 7.6 (vs 13.4) | Â | 37.2 (vs 14.4) |
FDA approval | 04/16/2018 | 04/22/2019 | 05/14/2019 | 01/21/2021 | 08/11/2021 |