CheckMate 9ER
Nivolumab with cabozantinib doubled progression-free survival versus sunitinib and lengthened life, with quality of life preserved.
PFS 16.6 vs 8.3 months (HR 0.51); OS HR 0.60 initially, 0.77 at final 4-year analysis (median 46.5 vs 36.0 months). FDA approval January 2021. Cabozantinib's MET/AXL activity is a proposed contributor.
- Median 16.6 vs 8.3 months with Nivolumab + cabozantinib compared with Sunitinib; about 8.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 49 percent lower chance of the event at any given time (hazard ratio 0.51, likely range 0.41 to 0.64).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- Median 46.5 vs 36 months with Nivolumab + cabozantinib compared with Sunitinib; about 10.5 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 23 percent lower chance of the event at any given time (hazard ratio 0.77, likely range 0.63 to 0.95).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Untreated advanced clear-cell RCC: nivolumab + cabozantinib vs sunitinib. People in a different situation may not see the same effect.
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.
651 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Nivolumab + cabozantinib | 323 | 16.6 months | 0.51 (0.41–0.64) | — | link |
| Sunitinib | 328 | 8.3 months | ||||
| Overall survival (final) | Nivolumab + cabozantinib | — | 46.5 months | 0.77 (0.63–0.95) | — | — |
| Sunitinib | — | 36 months |
Pages like this
not linked directly; found by shared links- TrialCOSMIC-313
Shares Cabozantinib, Nivolumab, Renal cell carcinoma.
- TrialCheckMate 214
Shares Sunitinib, Nivolumab, Renal cell carcinoma.
- TrialKEYNOTE-564
Shares Toni K. Choueiri, Renal cell carcinoma.
- TrialLITESPARK-005
Shares Toni K. Choueiri, Renal cell carcinoma.
- PairingCaution: PD-1 rechallenge after progression on immunotherapy (RCC)
Shares Cabozantinib, Nivolumab, Renal cell carcinoma.
- TrialCLEAR (KEYNOTE-581)
Shares Sunitinib, Renal cell carcinoma.
- TrialCONTACT-03
Shares Cabozantinib, Renal cell carcinoma.
- CompanyExelixis
Shares Cabozantinib, Renal cell carcinoma.