ANNOUNCE
A PDGFRα antibody that had won accelerated approval on a small trial failed to improve survival in the confirmatory study and was withdrawn.
OS 20.4 vs 19.7 months (HR 1.05); PFS HR 1.23. Olaratumab (Lartruvo) withdrawn 2019. A frequently cited lesson on phase 2 signals and accelerated approval.
Setting
Advanced soft-tissue sarcoma, first line: olaratumab + doxorubicin vs doxorubicin
Phase
Phase 3
Sponsor
Eli Lilly
Registry
Headline result
OS HR 1.05 (negative); drug withdrawn.
Reported
2019
Enrolled
509
In plain words
What these results mean for people, not percentages
Overall survival (median)primarysurvival endpoint
- Median 20.4 vs 19.7 months with Olaratumab + doxorubicin compared with Doxorubicin; about 0.7 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 5 percent higher chance of the event at any given time (hazard ratio 1.05, likely range 0.84 to 1.3).
- 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.
- These results apply to the people the trial enrolled: Advanced soft-tissue sarcoma, first line: olaratumab + doxorubicin vs doxorubicin. 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.