Tagrisso
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Overview

Seven times longer PFS with TAGRISSO® after CRT in unresectable EGFRm NSCLC1,2#

ESMO RECOMMENDED
PFSOS

Significantly improved progression-free survival2

  • 7x increased median PFS vs control arm
  • 39.1 months median PFS with TAGRISSO® (95% CI: 31,5, NC), vs 5.6 months with placebo (95% CI: 3.7, 7.4)
    (HR=0.16; 95% CI: 0.10, 0.24; P<0.001)
OSOS

Favorable trend in interim OS analysis4

70 % of patients alive after 4 years with TAGRISSO® vs 52% with placebo (HR=0.67; 95% CI: 0.40, 1.14; p=0.140)

CNSZNS

Less CNS progression and fewer new lesions2,5

  • 83 % reduction in the risk of CNS progression or death with TAGRISSO® versus placebo, in unresectable Stage III EGFRm NSCLC after definitive CRT.
    (HR = 0.17 (95% CI: 0.09, 0.32), P<0.001)
  • Across all lesion sites, the incidence of new lesions was lower in patients on TAGRISSO® (22%) than with placebo (68%)

# approved for the treatment of adult patients with locally advanced, unresectable NSCLC with EGFRm (L858R, Ex19del), whose disease has not progressed during or after platinum-based chemoradiotherapy1
CI: confidence interval; CNS: central nervous system; CRT: chemoradiotherapy ESMO: European Society for Medical Oncology; HR: hazard ratio; mPFS: median progression-free survival; OS: overall survival; PFS: progression free survival.

Study design

LAURA was a global, Phase III study investigating TAGRISSO® in patients who did not progress on or after CRT2,6,7

LAURA study design

Primary endpoint: Progression-free survival as assessed by BICR (blinded independent central review)2

Key secondary endpoints: Overall survival, CNS progression-free survival2

Baseline characteristics were well balanced in LAURA2

TAGRISSO® is the first and only targeted treatment available for your patients with unresectable Stage III NSCLC after definitive CRT

* Key exclusion criteria: History of ILD prior to CRT, symptomatic pneumonitis following CRT, QT prolongation, or any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG2,7

** Including at least 2 cycles of platinum-based chemotherapy and a total dose of radiation of 60 Gy±10% (54 to 66 Gy).7

BICR: blinded independent central review; CNS: central nervous system; CRT: chemoradiotherapy; ECG: electrocardiogram; EGFR: epidermal growth factor receptor; EGFRm: epidermal growth factor receptor mutation; Ex19del: exon 19 deletion; ILD: interstitial lung disease; L858R: exon 21 leucine 858 arginine substitution; MRI: magnetic resonance imaging; NSCLC: non-small cell lung cancer; PD: progressive disease; PS: performance status; RECIST: Response Evaluation Criteria in Solid Tumors; WHO: World Health Organization

Results

  • PFS
  • PFS in subgroups
  • CNS events/recurrence
  • Interim OS

TAGRISSO® demonstrated a 7x increase in median PFS vs control arm2

PFS graphic 1
84% reduction in risk of progression or death
  • Data maturity was 56% at time of analysis (median follow-up: 22 months in the TAGRISSO® arm and 5.6 months in the control arm)2
  • PFS results per investigator were consistent with this BICR analysis (HR=0.19 [95% CI: 0.12, 0.29])6
  • Among the 62 patients in the placebo arm, 81% (50/62) went on to receive open-label TAGRISSO® after progression2
Choose TAGRISSO® to deliver an unrivaled 39.1 months median PFS vs 5.6 months with placebo

CI: confidence interval; HR: hazard ratio; NC: not calculable; PFS: progression free survival.

Safety

  • Adverse reaction
  • Dose modification

Safety results from the LAURA trial were consistent with the known profiles of both TAGRISSO® and chemoradiation

ADVERSE REACTIONS OCCURRING IN ≥10% OF PATIENTS RECEIVING TAGRISSO® IN LAURA2

Adverse reactions table
  • There was a 13% rate of discontinuation in the TAGRISSO® arm and a 5% discontinuation rate in the placebo arm2
  • The impact of dose modification on treatment exposure time was minimal (23.7 months actual median exposure to TAGRISSO® vs 24.0 months total median exposure)2
  • The median duration of exposure to TAGRISSO® was 24.0 months vs 8.3 months in the placebo arm. Median duration of investigator follow-up was 22.2 months in the TAGRISSO® arm and 5.7 months in the placebo arm2,6
More information about ADJUVANT TAGRISSO® (ADAURA)

References:

  1. TAGRISSO® Information for Healthcare Professionals, www.swissmedicinfo.ch.
  2. Lu S, Kato T, Dong X, et al. LAURA investigators. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024;391(7):585-597.
  3. Zer A, Ahn MJ, Barlesi F, et al., on behalf of the ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up†. Published online: 28 August 2025, Annals of Oncology. https://www.esmo.org/guidelines/esmo-clinical-practice-guideline-early-stage-and-locally-advanced-non-small-cell-lung-cancer. Last access: 09/2025.
  4. Ramalingam SS, et al. LBA4: Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable (UR) stage III EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC): Updated overall survival (OS) analysis from the LAURA study [oral presentation]. Presented at: ELCC; March 26-29, 2025; Paris, France.
  5. Lu S, Ahn MJ, Reungwetwattana T, et al. Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA satudy. Ann Oncol. 2024:S0923-7534(24)03823-7.
  6. Lu S, Kato T, Dong X, et al. LAURA investigators. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024;391(7):585-597 (supplementary appendix).
  7. Lu S, Kato T, Dong X, et al. LAURA investigators. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024;391(7):585-597 (protocol).

Professionals can request the mentioned references from AstraZeneca AG.