OnCo
trialsTrialPositive

FLAURA2

Adding chemotherapy to osimertinib extended both progression-free and, in 2025, overall survival.

PFS 25.5 vs 16.7 months (HR 0.62); OS HR 0.77 (2025).

Setting
First-line EGFR-mutant NSCLC: osimertinib + chemotherapy vs osimertinib
Phase
Phase 3
Sponsor
AstraZeneca
Registry
Headline result
PFS HR 0.62; OS HR 0.77.
Reported
2023
Enrolled
557
Replication
Consistent with MARIPOSA in showing that intensifying first-line therapy beyond osimertinib alone extends survival; the two regimens have not been compared directly.

Outcomes

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In plain words
What these results mean for people, not percentages
557 people took part
Progression-free survival (investigator)primarysurrogate endpoint
  • Median 25.5 vs 16.7 months with Osimertinib + chemotherapy compared with Osimertinib; about 8.8 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 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.49 to 0.79).
  • 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 survivalsurvival endpoint
  • Median 47.5 vs 37.6 months with Osimertinib + chemotherapy compared with Osimertinib; about 9.9 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 23 percent lower chance of the event at any given time (hazard ratio 0.77, likely range 0.61 to 0.96).
  • 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: First-line EGFR-mutant NSCLC: osimertinib + chemotherapy vs osimertinib. 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.

557 participants enrolled.

Progression-free survival (investigator)primary
HR 0.62 (0.49–0.79) · p <0.001
Osimertinib + chemotherapy
25.5 mo
Osimertinib
16.7 mo
Source
Overall survival
HR 0.77 (0.61–0.96) · p = 0.02
Osimertinib + chemotherapy
47.5 mo
Osimertinib
37.6 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (investigator)primaryOsimertinib + chemotherapy27925.5 months0.62 (0.49–0.79)<0.001link
Osimertinib27816.7 months
Overall survivalOsimertinib + chemotherapy47.5 months0.77 (0.61–0.96)0.02link
Osimertinib37.6 months
Replication
Consistent with MARIPOSA in showing that intensifying first-line therapy beyond osimertinib alone extends survival; the two regimens have not been compared directly.

Key papers

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Connected

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