OnCo
trialsTrialPositive

FRESCO-2

A selective VEGF-receptor pill gave a modest but real survival gain in patients with no remaining standard treatment.

OS 7.4 vs 4.8 months (HR 0.66, Lancet 2023). FDA approval November 2023. Better tolerated than regorafenib; hypertension and hand-foot syndrome are the main toxicities.

Setting
Refractory metastatic colorectal cancer after all standard therapies: fruquintinib vs placebo
Phase
Phase 3
Sponsor
HUTCHMED / Takeda
Registry
Headline result
OS 7.4 vs 4.8 months, HR 0.66.
Reported
2023
Enrolled
691
Replication
Replicates the Chinese FRESCO trial (OS 9.3 vs 6.6 months).

Outcomes

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In plain words
What these results mean for people, not percentages
691 people took part
Overall survivalprimarysurvival endpoint
  • Median 7.4 vs 4.8 months with Fruquintinib compared with Placebo; about 2.6 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 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.55 to 0.8).
  • 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: Refractory metastatic colorectal cancer after all standard therapies: fruquintinib 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.

691 participants enrolled.

Overall survivalprimary
HR 0.66 (0.55–0.8)
Fruquintinib
7.4 mo
Placebo
4.8 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryFruquintinib4617.4 months0.66 (0.55–0.8)link
Placebo2304.8 months
Replication
Replicates the Chinese FRESCO trial (OS 9.3 vs 6.6 months).

Connected

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