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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.

Outcomes

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In plain words
What these results mean for people, not percentages
522 people took part
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
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryAtezolizumab + cabozantinib26310.6 months1.03 (0.83–1.28)link
Cabozantinib25910.8 months
Replication
Replicated by TiNivo-2 (2024-26): no benefit from nivolumab rechallenge with tivozanib.

Connected

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