OnCo
trialsTrialMixed

COSMIC-313

The first triplet trial in kidney cancer slowed progression but did not help patients live longer, and added toxicity.

PFS HR 0.73 (met primary endpoint) but final OS HR 1.02 (41.9 vs 42.0 months) and grade 3-4 events 79% vs 56%. Not approved. Poor-risk patients did not benefit even on PFS.

Setting
Untreated intermediate/poor-risk clear-cell RCC: cabozantinib + nivolumab + ipilimumab vs nivolumab + ipilimumab
Phase
Phase 3
Sponsor
Exelixis
Registry
NCT03937219
Headline result
PFS HR 0.73; OS HR 1.02 (no benefit).
Reported
2022
Enrolled
855
Replication
Consistent with LITESPARK-012: first-line triplets have not improved OS in RCC.

Outcomes

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In plain words
What these results mean for people, not percentages
855 people took part
Progression-free survivalprimarysurrogate endpoint
  • The treated group had about 27 percent lower chance of the event at any given time (hazard ratio 0.73).
  • The absolute difference, how many more people out of 100 were helped, is not reported here.
  • 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.
Overall survival (final)survival endpoint
  • Median 41.9 vs 42 months with Triplet compared with Doublet; about 0.1 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 2 percent higher chance of the event at any given time (hazard ratio 1.02, likely range 0.85 to 1.23).
  • The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Untreated intermediate/poor-risk clear-cell RCC: cabozantinib + nivolumab + ipilimumab vs nivolumab + ipilimumab. 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.

855 participants enrolled.

Progression-free survivalprimary
HR 0.73 (0.57–0.94)

Numbers not yet public.

Source
Overall survival (final)
HR 1.02 (0.85–1.23)
Triplet
41.9 mo
Doublet
42 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryCabozantinib + nivolumab + ipilimumab428—0.73 (0.57–0.94)—link
Nivolumab + ipilimumab427—
Overall survival (final)Triplet—41.9 months1.02 (0.85–1.23)—link
Doublet—42 months
Replication
Consistent with LITESPARK-012: first-line triplets have not improved OS in RCC.

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Renal cell carcinoma

drugs

3
ApprovedSmall-molecule multi-kinase inhibitor (MET, VEGFR2, AXL, RET)
Cabozantinib · Cabometyx
ApprovedMonoclonal antibody (anti-CTLA-4)
Ipilimumab · Yervoy
ApprovedMonoclonal antibody (anti-PD-1)
Nivolumab · Opdivo / Opdivo Qvantig (SC)