Skip to content
Bending the Curve Trial by Trial
?

FLAURA2

Osimertinib with or without platinum-pemetrexed chemotherapy in EGFR-mutated advanced NSCLC (FLAURA2)

Phase 3N = 557NCT04035486

Population
Previously untreated EGFR-mutated (exon 19 deletion or L858R) advanced NSCLC
Design
International open-label phase 3 trial, 1:1 randomisation; primary endpoint investigator-assessed progression-free survival; overall survival the key secondary endpoint (planned final analysis published separately)
Primary endpoint
PFS
Arms
  • Osimertinib plus chemotherapy (experimental, n = 279): Osimertinib 80 mg once daily plus pemetrexed 500 mg per square metre and cisplatin 75 mg per square metre or carboplatin
  • Osimertinib (control, n = 278): Osimertinib 80 mg once daily
People
Planchard D, FLAURA2 Investigators
PFSHR 0.62 (95% CI 0.49–0.79)Δ 24-month PFS+16 pointsPFSHR 0.62 (95% CI 0.48–0.80)PFSHR 0.62 (95% CI 0.49–0.79)Δ median PFS+8.8 monthsΔ ORR+7 points
Show the numbers
Results reported for FLAURA2
EndpointAnalysisOsimertinib plus chemotherapyOsimertinibEffect
PFSAll randomised patients (n=557)Investigator-assessedprimaryPlanchard 202357% at 2 y (50–63%)41% at 2 y (35–47%)HR 0.62 (95% CI 0.49–0.79)P<0.001Median PFS is not given in the abstract; see the label-based result.
PFSAll randomised patients (n=557)Blinded independent central reviewprimaryPlanchard 2023——HR 0.62 (95% CI 0.48–0.80)Consistent with the primary analysis.
PFSAll randomised patients (n=557)Investigator-assessedprimarySource 2024median 25.5 monthsmedian 16.7 months (14.1–21.3)HR 0.62 (95% CI 0.49–0.79)P<0.0001From the FDA label (investigator assessment), not from the PubMed abstract; the upper confidence bound for the combination median is not estimable (24.7 months to NE).
ORRAll randomised patients (n=557)primaryPlanchard 202383%76%The FDA label reports 77% vs 69% for confirmed responses; the abstract does not say whether its percentages are confirmed.
OSAll randomised patients (n=557)finalJänne 2026median 47.5 monthsmedian 37.6 monthsHR 0.77 (95% CI 0.61–0.96)P=0.02Planned final overall survival analysis.
Results reported for FLAURA2
EndpointAnalysisOsimertinib plus chemotherapyOsimertinibEffect
PFSAll randomised patients (n=557)Investigator-assessedprimaryPlanchard 202357% at 2 y (50–63%)41% at 2 y (35–47%)HR 0.62 (95% CI 0.49–0.79)P<0.001Median PFS is not given in the abstract; see the label-based result.
PFSAll randomised patients (n=557)Blinded independent central reviewprimaryPlanchard 2023——HR 0.62 (95% CI 0.48–0.80)Consistent with the primary analysis.
PFSAll randomised patients (n=557)Investigator-assessedprimarySource 2024median 25.5 monthsmedian 16.7 months (14.1–21.3)HR 0.62 (95% CI 0.49–0.79)P<0.0001From the FDA label (investigator assessment), not from the PubMed abstract; the upper confidence bound for the combination median is not estimable (24.7 months to NE).
ORRAll randomised patients (n=557)primaryPlanchard 202383%76%The FDA label reports 77% vs 69% for confirmed responses; the abstract does not say whether its percentages are confirmed.
OSAll randomised patients (n=557)finalJänne 2026median 47.5 monthsmedian 37.6 monthsHR 0.77 (95% CI 0.61–0.96)P=0.02Planned final overall survival analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSPFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.620.49–0.79
PFS0.620.48–0.8
PFS0.620.49–0.79
OS0.770.61–0.96
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Osimertinib plus chemotherapy (experimental)
  • Osimertinib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsOsimertinib plus chemotherapyOsimertinib
0100.0%100.0%
1664.7%51.5%
3241.9%26.5%
4827.1%13.6%
6417.6%7.0%
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%020406080100Months (modelled)
  • Osimertinib plus chemotherapy (experimental)
  • Osimertinib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsOsimertinib plus chemotherapyOsimertinib
0100.0%100.0%
3064.5%57.5%
5942.3%33.7%
8927.3%19.4%
11917.6%11.1%
Primary publication: Planchard D, Jänne PA, Cheng Y, Yang JC, Yanagitani N, Kim SW, et al. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023;389(21):1935-1948. PubMedDOI

Appears in

Sources

  1. Planchard D, Jänne PA, Cheng Y, Yang JC, Yanagitani N, Kim SW, et al. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023;389(21):1935-1948.

    PubMedDOI

  2. US Food and Drug Administration. Tagrisso (osimertinib) prescribing information, supplement 30 labeling (Reference ID 5331000), section 14.3, February 2024.

    Source

  3. Jänne PA, Planchard D, Kobayashi K, Yang JC, Liu Y, Valdiviezo N, et al. Survival with Osimertinib plus Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026;394(1):27-38.

    PubMedDOI