Disease recurrence is an
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The first and only EGFR TKI to help prevent disease recurrence

Adjuvant TAGRISSO: Delivering overwhelming efficacy

TAGRISSO demonstrated extraordinary disease-free survival in resected EGFRm NSCLC patients.
Consistent results with or without prior adjuvant chemotherapy1-3*

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

TAGRISSO® (osimertinib) disease-free survival (DFS) results in resectable stage II-IIIA EGFRm NSCLC patients TAGRISSO® (osimertinib) disease-free survival (DFS) results in resectable stage II-IIIA EGFRm NSCLC patients

*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

Yet unseen efficacy results with a targeted therapy in stage IB-IIIA resectable EGFRm NSCLC

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

Consistent results seen with or without prior adjuvant chemotherapy1-3*

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

TAGRISSO® (osimertinib) disease-free survival (DFS) in resectable stage IB-IIIA EGFRm NSCLC TAGRISSO® (osimertinib) disease-free survival (DFS) in resectable stage IB-IIIA EGFRm NSCLC

*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) for control arm.1 Control arm=placebo.
Disease recurrence is an
important consideration for your patients.
LEARN MORE >

In resectable EGFRm NSCLC

Adjuvant TAGRISSO: Consistent DFS results across all patient types

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

TAGRISSO® (osimertinib) disease-free survival (DFS) patient subgroup data TAGRISSO® (osimertinib) disease-free survival (DFS) patient subgroup data

*Exploratory analysis. Stages IB-IIIA. Control arm=placebo.
  • Adjuvant chemotherapy was used for 25% of stage IB, 70% of stage II, and 81% of stage IIIA patients taking TAGRISSO in the ADAURA study4

ADAURA: A phase III double-blind trial of patients with completely resected stage IB, II, IIIA EGFRm NSCLC1*

Adjuvant chemotherapy before randomization was allowed, but not mandatory. Decisions on whether patients received adjuvant chemotherapy were made by the physician and patient, and occurred before study enrollment2

ADAURA Phase 3 trial of patients with completely resected stage IB-IIIA EGFRm NSCLC ADAURA Phase 3 trial of patients with completely resected stage IB-IIIA EGFRm NSCLC

Primary endpoint: DFS by investigator assessment in stage II/IIIA patients.2

Secondary endpoints: 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.1,2,5

Exploratory endpoints: Assessment of the site or sites of recurrence (including the CNS); time to CNS disease recurrence or death.2

Key inclusion criteria: Patients were required to have a WHO PS of 0/1 and an exon 19 deletion or L858R mutation. Patients were required to be ≥18 years old. Brain imaging, if not completed pre-operatively, was required. Complete resection with negative margins was required.2,4

Key exclusion criteria: Wedge resection or radiation therapy.4

*EGFRm patients with completely resected stage IB, II, and IIIA NSCLC tumors as defined by AJCC 7th edition were enrolled in ADAURA.1 Patients were stratified by stage (IB vs II vs IIIA), EGFR mutation (exon 19 deletion or L858R), and race (Asian vs non-Asian).1

The ADAURA data were released 2 years early, as recommended by an independent data monitoring committee due to overwhelming efficacy. Investigators and patients continue to participate in the trial and remain blinded to treatment2

ADAURA baseline characteristics were well balanced—including stage of disease, prior adjuvant chemotherapy, and clinical characteristics

ADAURA DEMOGRAPHICS IN STAGE IB, II, AND IIIA PATIENTS2,4

Patient demographics in ADAURA trial Patient demographics in ADAURA trial

*Based on the AJCC 8th edition updates, many patients who were originally classified as stage IB by AJCC 7th edition are still classified as stage IB, while some are now considered to be stage IIA. Stage IB patients with T2a >3-4 cm-sized tumors and N0 nodal involvement are still considered stage IB. Stage IB patients with T2b >4-5 cm-sized tumors (formerly T2a in AJCC 7th edition) and N0 nodal involvement are now considered stage IIA. Based on the AJCC 8th edition updates, certain patients classified as stage IIIA by AJCC 7th edition are now considered to be stage IIIB. In the AJCC 8th edition, stage IIIB may reflect N2 nodal disease, including N2 with T3 invasion or N2 with T3 satellite. Thus, these stage IIIB patients, as defined by AJCC 8th edition updates, were included in the ADAURA trial.
See first-line results for TAGRISSO
in metastatic EGFRm NSCLC
AJCC, American Joint Committee on Cancer; CI, confidence interval; CNS, central nervous system; 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; NE, not estimable; NSCLC, non-small cell lung cancer; po, by mouth; qd, once daily; QoL, quality of life; PS, performance status; TKI, tyrosine kinase inhibitor; WHO, World Health Organization.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Wu YL, Tsuboi M, He J, et al. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2020;383(18):1711-1723. 3. DoFP. REF-98491. AstraZeneca Pharmaceuticals LP. 4. Wu YL, Tsuboi M, He J, et al. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2020;383(18):1711-1723 [supplementary appendix]. 5. DoFP. REF-98825. AstraZeneca Pharmaceuticals LP. 6. Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A III, eds. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer; 2010. 7. Rami-Porta R, Asamura H, Travis WD, Rusch VW. Lung cancer—major changes in the American Joint Committee on cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017;67(2):138-155.

Important Safety Information Expand

  • 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


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