OnCo
trialsTrialPositive

ROAR (anaplastic thyroid cancer cohort)

Turned the most lethal thyroid cancer from a months-long death sentence into a treatable disease for the third of patients whose tumours carry a BRAF mutation.

ORR 56%; median OS 15 months with 12-month OS 52% versus historical medians under 6 months (updated analysis, Annals of Oncology 2022). FDA approval May 2018, the first targeted therapy for ATC; neoadjuvant use now enables surgery in previously unresectable tumours.

Setting
BRAF V600E-mutant anaplastic thyroid cancer: dabrafenib + trametinib
Phase
Phase 2
Sponsor
Novartis
Registry
Headline result
ORR 56%; median OS 15 months.
Reported
2018
Enrolled
36
Replication
Consistent with MD Anderson real-world series of neoadjuvant BRAF/MEK in ATC.

Outcomes

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In plain words
What these results mean for people, not percentages
36 people took part
Objective response rateprimaryresponse endpoint
  • 56 out of 100 people had their tumour shrink with Dabrafenib + trametinib.
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
  • These results apply to the people the trial enrolled: BRAF V600E-mutant anaplastic thyroid cancer: dabrafenib + trametinib. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (BRAF); the result should not be assumed for people whose cancer does not have it.
  • Only 36 people took part, so the numbers are less certain than in a large trial.

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.

36 participants enrolled.

Objective response rateprimary
Dabrafenib + trametinib56 of 100
n = 36
Source
EndpointArmnValueHR (95% CI)pSource
Objective response rateprimaryDabrafenib + trametinib3656%link
Replication
Consistent with MD Anderson real-world series of neoadjuvant BRAF/MEK in ATC.

Connected

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