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Continuing immunotherapy after it has failed, alongside a targeted pill, added nothing but side effects. The first definitive test of 'IO rechallenge'.
PFS HR 1.03; OS HR 0.94; more toxicity. Lancet 2023. Confirmed in 2026 by TiNivo-2 (tivozanib ± nivolumab). Changed practice: PD-1 rechallenge after progression is no longer recommended.
Setting
Advanced RCC progressing on or after a PD-1/PD-L1 inhibitor: atezolizumab + cabozantinib vs cabozantinib
Phase
Phase 3
Sponsor
Roche / Exelixis
Registry
Headline result
PFS HR 1.03; OS HR 0.94, negative.
Reported
2023
Enrolled
522
Replication
Replicated by TiNivo-2 (2024-26): no benefit from nivolumab rechallenge with tivozanib.
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 10.6 vs 10.8 months with Atezolizumab + cabozantinib compared with Cabozantinib; about 0.2 months shorter 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 3 percent higher chance of the event at any given time (hazard ratio 1.03, likely range 0.83 to 1.28).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- 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.
- These results apply to the people the trial enrolled: Advanced RCC progressing on or after a PD-1/PD-L1 inhibitor: atezolizumab + cabozantinib vs cabozantinib. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PD-1); the result should not be assumed for people whose cancer does not have it.
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.
522 participants enrolled.
Progression-free survivalprimary
HR 1.03 (0.83–1.28)
Atezolizumab + cabozantinib
10.6 mo
Cabozantinib
10.8 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Atezolizumab + cabozantinib | 263 | 10.6 months | 1.03 (0.83–1.28) | — | link |
| Cabozantinib | 259 | 10.8 months |
Replication
Replicated by TiNivo-2 (2024-26): no benefit from nivolumab rechallenge with tivozanib.