OnCo
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INVICTUS

Ripretinib kept fourth-line GIST under control six times longer than placebo and improved survival.

PFS 6.3 vs 1.0 months (HR 0.15); OS 15.1 vs 6.6 months (HR 0.36). Approved May 2020.

Setting
Advanced GIST after ≥3 kinase inhibitors: ripretinib vs placebo
Phase
Phase 3
Sponsor
Deciphera
Registry
Headline result
PFS HR 0.15; OS HR 0.36.
Reported
2020
Enrolled
129

Outcomes

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In plain words
What these results mean for people, not percentages
129 people took part
Progression-free survival (median)primarysurrogate endpoint
  • Median 6.3 vs 1 months with Ripretinib compared with Placebo; about 5.3 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 85 percent lower chance of the event at any given time (hazard ratio 0.15, likely range 0.09 to 0.25).
  • 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 (median)survival endpoint
  • Median 15.1 vs 6.6 months with Ripretinib compared with Placebo; about 8.5 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 64 percent lower chance of the event at any given time (hazard ratio 0.36).
  • 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: Advanced GIST after ≥3 kinase inhibitors: ripretinib vs placebo. 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.

129 participants enrolled.

Progression-free survival (median)primary
HR 0.15 (0.09–0.25) · p <0.0001
Ripretinib
6.3 mo
Placebo
1 mo
Source
Overall survival (median)
HR 0.36
Ripretinib
15.1 mo
Placebo
6.6 mo
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (median)primaryRipretinib856.3 months0.15 (0.09–0.25)<0.0001link
Placebo441 months
Overall survival (median)Ripretinib15.1 months0.36
Placebo6.6 months

Connected

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