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LAURA

Osimertinib after chemoradiotherapy in unresectable stage III EGFR-mutated NSCLC (LAURA)

Phase 3N = 216NCT03521154

Population
Unresectable EGFR-mutated stage III NSCLC without progression during or after chemoradiotherapy
Design
Double-blind, placebo-controlled phase 3 trial (143 osimertinib, 73 placebo); osimertinib or placebo until progression by blinded independent central review or discontinuation; primary endpoint PFS by blinded independent central review
Primary endpoint
PFS
Arms
  • Osimertinib (experimental, n = 143): Osimertinib 80 mg daily
  • Placebo (control, n = 73): Placebo
People
Lu S, LAURA Trial Investigators
PFSHR 0.16 (95% CI 0.10–0.24)Δ median PFS+33.5 monthsΔ 12-month PFS+52 pointsOSHR 0.81 (95% CI 0.42–1.56)Δ 36-month OS+10 points
Show the numbers
Results reported for LAURA
EndpointAnalysisOsimertinibPlaceboEffect
PFSAll randomised patients (n=216)Blinded independent central reviewprimaryLu 2024median 39.1 months; 74% at 12 mo (65–80%)median 5.6 months; 22% at 12 mo (13–32%)HR 0.16 (95% CI 0.10–0.24)P<0.001
OSAll randomised patients (n=216)interimLu 202484% at 3 y (75–89%)74% at 3 y (57–85%)HR 0.81 (95% CI 0.42–1.56)P=0.53Interim analysis at 20% maturity.
Results reported for LAURA
EndpointAnalysisOsimertinibPlaceboEffect
PFSAll randomised patients (n=216)Blinded independent central reviewprimaryLu 2024median 39.1 months; 74% at 12 mo (65–80%)median 5.6 months; 22% at 12 mo (13–32%)HR 0.16 (95% CI 0.10–0.24)P<0.001
OSAll randomised patients (n=216)interimLu 202484% at 3 y (75–89%)74% at 3 y (57–85%)HR 0.81 (95% CI 0.42–1.56)P=0.53Interim analysis at 20% maturity.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.160.1–0.24
OS0.810.42–1.56
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Osimertinib (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsOsimertinibPlacebo
0100.0%100.0%
2465.3%5.1%
4942.0%0.2%
7327.4%0.0%
9817.6%0.0%
Primary publication: Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024;391(7):585-597. PubMedDOI

Appears in

Sources

  1. Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024;391(7):585-597.

    PubMedDOI