In resectable stage II and IIIA EGFRm NSCLC patients

Adjuvant TAGRISSO: Delivering overwhelming efficacy

TAGRISSO demonstrated extraordinary disease-free survival in resected EGFRm NSCLC patients

Consistent results with or without prior adjuvant chemotherapy1,2*

PRIMARY ENDPOINT: DISEASE-FREE SURVIVAL IN PATIENTS WITH STAGE II/IIIA DISEASE (N=470)

Disease-free survival for TAGRISSO in resected Stage II-IIIA EGFRm NSCLC patients Disease-free survival for TAGRISSO in resected Stage II-IIIA EGFRm NSCLC patients

83% reduction in risk of cancer coming back or death; HR=0.17 (95% CI: 0.12, 0.23); P<0.0001

*Exploratory subgroup results for patients with adjuvant chemotherapy was HR=0.16 (95% CI: 0.10, 0.26) and for patients without adjuvant chemotherapy was HR=0.23 (95% CI: 0.13, 0.40).2

Median DFS was not reached for TAGRISSO (95% CI: 38.8, NE) and was 19.6 months (95% CI: 16.6, 24.5) for control arm.1

Control arm=placebo.

Patients in the ADAURA trial are treated with ORAL TAGRISSO FOR 3 YEARS or until disease recurrence or unacceptable toxicity1

Adjuvant TAGRISSO:
The only choice for disease-free survival across all stages of disease studied, which included resectable stage IB-IIIA EGFRm NSCLC patients

Consistent results seen with or without prior adjuvant chemotherapy1,2*

DISEASE FREE SURVIVAL IN THE OVERALL POPULATION (STAGE IB/II/IIIA) (N=682)

Disease-free survival results for TAGRISSO in resected Stage IB-IIIA EGFRm NSCLC patients Disease-free survival results for TAGRISSO in resected Stage IB-IIIA EGFRm NSCLC patients

80% reduction in risk of cancer coming back or death; HR=0.20 (95% CI: 0.15, 0.27); P<0.0001

*Exploratory subgroup results for patients with adjuvant chemotherapy was HR=0.16 (95% CI: 0.10, 0.26) and for patients without adjuvant chemotherapy was HR=0.23 (95% CI: 0.13, 0.40).2

Secondary endpoint: Median DFS was not reached (95% CI: NE, NE) for TAGRISSO and was 27.5 months (95% CI: 22.0, 35.0) months for control arm.1

Control arm=placebo.

Patients in the ADAURA trial are treated for 3 years or until disease recurrence or unacceptable toxicity1

ADAURA study design: Phase III, double-blind, randomized, placebo-controlled trial in 682 patients with completely resected stage IB, II, and IIIA NSCLC with or without adjuvant chemotherapy. NSCLC patients had centrally confirmed EGFR mutations (exon 19 deletion or L858R mutation). Patients were stratified by stage (IB vs II vs IIIA), EGFR mutation (exon 19 deletion or L858R), and race (Asian vs non-Asian). Patients were randomized to either TAGRISSO (n=339; 80 mg orally, once daily) or placebo (n=343). The maximum interval between surgery and randomization was 26 weeks with adjuvant chemotherapy and 10 weeks without adjuvant chemotherapy. The primary endpoint of the study was DFS by investigator assessment in stage II/IIIA patients. The secondary endpoints were DFS in the overall population (stage IB/II/IIIA); DFS rate at 2, 3, 4, and 5 years; overall survival (stage II/IIIA and overall population); safety; and health-related QoL. The planned treatment duration was 3 years or until disease recurrence/unacceptable toxicity.1,2

Adjuvant TAGRISSO: Consistent DFS results across all patient types

Reduced risk of disease recurrence or death across all prespecified subgroups, including patients with or without prior adjuvant chemotherapy2*

Disease-free survival data for prespecified patient subgroups in the ADAURA clinical trial Disease-free survival data for prespecified patient subgroups in the ADAURA clinical trial

  • Adjuvant chemotherapy was used in 25% of stage IB, 70% of stage II, and 81% of stage IIIA patients taking TAGRISSO in the ADAURA study2

*Exploratory analysis.

Stages IB-IIIA.

Control arm=placebo.

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National Comprehensive Cancer Network® (NCCN®) recommends clinicopathologic features such as ethnicity, smoking status, or histology NOT be used to select patients for EGFR mutational testing.3

Ensure every eligible patient is tested for EGFR mutations.

Regardless of patient type or stage of resectable disease: TEST for EGFR mutations, TREAT with TAGRISSO1

CI, confidence interval; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation positive; ex19del, exon 19 deletion; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NSCLC, non-small cell lung cancer; NE, not estimable; QoL, quality of life; T790M, exon 20 threonine 790 methionine substitution.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer [article and supplementary material]. N Engl J Med. 2020;383(18):1711-1723. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.4.2021. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 3, 2021. 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.

IMPORTANT SAFETY INFORMATION

  • There are no contraindications for TAGRISSO
  • Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of the 1479 TAGRISSO-treated patients; 0.3% of cases were fatal. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed
  • Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 1479 TAGRISSO-treated patients in clinical trials, 0.8% were found to have a QTc >500 msec, and 3.1% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
  • Cardiomyopathy occurred in 3% of the 1479 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 3.2% of 1233 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
  • Keratitis was reported in 0.7% of 1479 patients treated with TAGRISSO in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
  • Postmarketing cases consistent with Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed
  • Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
  • Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose
  • Most common (≥20%) adverse reactions, including laboratory abnormalities, were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough

INDICATIONS

  • TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

  • TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

  • TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

For additional information, please see the complete Prescribing Information, including Patient Information.

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