Tagrisso
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Overview

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

NCCN 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)
PFSPFS

Consistent PFS benefits across all prespecified subgroups2

Including smoking history, cancer stage (from IIIA to IIIC) and EGFR mutation type

CNSZNS

Less CNS progression and fewer new lesions2,3

  • 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 HR: hazard ratio; mPFS: median progression-free survival; NCCN: National Comprehensive Cancer Network; PFS: progression free survival.

Study design

LAURA was a global, Phase III study investigating TAGRISSO® in patients who did not progress on or after CRT2,5,6

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 ECG2,6

** Including at least 2 cycles of platinum-based chemotherapy and a total dose of radiation of 60 Gy±10% (54 to 66 Gy).6

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

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])5
  • 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 arm2,5
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. 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 study. Ann Oncol. 2024:S0923-7534(24)03823-7.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.9.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 30, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  5. 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].
  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 [protocol].

Professionals can request the mentioned references from AstraZeneca AG.