The first immunotherapy plus targeted-pill combination for kidney cancer, improving survival across all risk groups.
KEYNOTE-426, trial NCT02853331 sponsored by Merck and reported in 2019, produced the first immunotherapy plus targeted tablet combination for kidney cancer, improving survival across all risk groups. It randomised 861 patients with untreated advanced clear-cell renal cell carcinoma to pembrolizumab plus axitinib or sunitinib, met its primary overall and progression-free survival endpoints, and led to FDA approval in April 2019, although the survival advantage attenuated over five years as control patients crossed over to later-line immunotherapy. OnCo links it to renal cell carcinoma, pembrolizumab, axitinib, sunitinib, the IMDC risk group term, Thomas Powles, Brian I. Rini and Jae Lyun Lee. Whether the shrinking long-term difference means the combination mainly brings immunotherapy forward rather than adding to it is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
861 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (final, 5-year)primary | Pembrolizumab + axitinib | 432 | 47.2 months | 0.84 (0.71 to 0.99) | - | link |
| Sunitinib | 429 | 40.8 months | ||||
| Progression-free survivalprimary | Pembrolizumab + axitinib | - | 15.7 months | 0.69 | - | link |
| Sunitinib | - | 11.1 months |
Shares IMDC risk groups (favourable / intermediate / poor), Axitinib, Renal cell carcinoma, Pembrolizumab.
Shares IMDC risk groups (favourable / intermediate / poor), Clear cell renal cell carcinoma, Sunitinib, Renal cell carcinoma.
Shares IMDC risk groups (favourable / intermediate / poor), Sunitinib, Renal cell carcinoma, Pembrolizumab.
Shares Clear cell renal cell carcinoma, Merck & Co. (MSD), Renal cell carcinoma, Pembrolizumab.
Shares Jae Lyun Lee, Clear cell renal cell carcinoma, Merck & Co. (MSD), Renal cell carcinoma.
Shares Clear cell renal cell carcinoma, Sunitinib, Renal cell carcinoma.
Shares Axitinib, Renal cell carcinoma, Pembrolizumab.
Shares Axitinib, Pembrolizumab, Immune checkpoint inhibitors.