FLAURA
FLAURA showed that starting with the third-generation EGFR drug osimertinib, rather than saving it for later, kept lung cancer under control for almost twice as long and helped people live longer.
Overview
FLAURA randomised 556 patients with untreated advanced non-small-cell lung cancer carrying an EGFR exon 19 deletion or L858R mutation to osimertinib or to a first-generation inhibitor, gefitinib or erlotinib. Osimertinib had been designed to hit the T790M resistance mutation and to spare wild-type EGFR, and the question was whether using it first beat using it after the older drugs failed.
Median progression-free survival was 18.9 months with osimertinib against 10.2 months with the comparator (hazard ratio 0.46), with fewer brain progressions and less rash and diarrhoea. The final analysis in 2020 showed median overall survival of 38.6 months against 31.8 months (hazard ratio 0.80), even though a third of the comparator arm crossed over to osimertinib.
The FDA approved osimertinib for first-line use in April 2018 and it became the standard against which FLAURA2 and MARIPOSA were later measured.
- Median 18.9 vs 10.2 months with Osimertinib compared with Gefitinib or erlotinib; about 8.7 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 54 percent lower chance of the event at any given time (hazard ratio 0.46).
- 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.
- Median 38.6 vs 31.8 months with Osimertinib compared with Gefitinib or erlotinib; about 6.8 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 20 percent lower chance of the event at any given time (hazard ratio 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: Untreated advanced non-small-cell lung cancer with an EGFR exon 19 deletion or L858R mutation: osimertinib versus gefitinib or erlotinib. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFR); the result should not be assumed for people whose cancer does not have it.
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.
556 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Osimertinib | 279 | 18.9 months | 0.46 | - | link |
| Gefitinib or erlotinib | 277 | 10.2 months | ||||
| Overall survival | Osimertinib | 279 | 38.6 months | 0.8 | - | link |
| Gefitinib or erlotinib | 277 | 31.8 months |
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