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Nivolumab with cabozantinib doubled progression-free survival versus sunitinib and lengthened life, with quality of life preserved.
CheckMate 9ER, trial NCT03141177 sponsored by Bristol Myers Squibb and Exelixis and reported in 2020, showed that nivolumab with cabozantinib doubled progression-free survival versus sunitinib in untreated advanced clear-cell renal cell carcinoma and lengthened life, with quality of life preserved. It randomised 651 patients, met its primary progression-free survival endpoint, improved overall survival with the effect narrowing at the final four-year analysis, and led to FDA approval in January 2021; cabozantinib's MET and AXL activity is a proposed contributor. OnCo links it to renal cell carcinoma, nivolumab, cabozantinib, sunitinib, Robert J. Motzer, Toni K. Choueiri and James Larkin. Choosing between the IO-TKI doublets without head-to-head data 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.
701 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Nivolumab + cabozantinib | 323 | 16.6 months | 0.51 (0.41 to 0.64) | - | link |
| Sunitinib | 328 | 8.3 months | ||||
| Overall survival (final) | Nivolumab + cabozantinib | - | 46.5 months | 0.77 (0.63 to 0.95) | - | link |
| Sunitinib | - | 36 months |
Shares Robert J. Motzer, Renal cell carcinoma, Nivolumab, Immune checkpoint inhibitors.
Shares Exelixis, Cabozantinib, Renal cell carcinoma, Nivolumab.
Shares Robert J. Motzer, Sunitinib, Renal cell carcinoma, Nivolumab.
Shares Toni K. Choueiri, Robert J. Motzer, Progression-free survival (PFS), Renal cell carcinoma.
Shares Exelixis, Sunitinib, Cabozantinib, Renal cell carcinoma.
Shares Exelixis, Cabozantinib, Renal cell carcinoma, Immune checkpoint inhibitors.
Shares Exelixis, Cabozantinib, Immune checkpoint inhibitors.
Shares Sunitinib, Cabozantinib, Renal cell carcinoma, Nivolumab.