See TAGRISSO efficacy in
resected EGFRm NSCLC

In metastatic EGFRm NSCLC

First-line TAGRISSO: Groundbreaking progression-free survival1

PFS IN THE PHASE 3 FLAURA STUDY

PFS in the phase 3 TAGRISSO (osimertinib) FLAURA study PFS in the phase 3 TAGRISSO (osimertinib) FLAURA study

  • In the FLAURA study, all US patients in the comparator arm received erlotinib2

First-line TAGRISSO delivered unprecedented median PFS of 18.9 months and cut the risk of progression or death by 54% vs EGFR-TKI comparator1

 

In metastatic EGFRm NSCLC

In a global phase 3 randomized study

First-line TAGRISSO: The only choice for statistically significant median Overall Survival beyond 3 years1

OVERALL SURVIVAL IN THE PHASE 3 FLAURA STUDY

TAGRISSO (osimertinib) Overall Survival (OS) in Phase 3 FLAURA Study TAGRISSO (osimertinib) Overall Survival (OS) in Phase 3 FLAURA Study

At 3 years, 54% of TAGRISSO patients and 44% of EGFR-TKI comparator patients were still alive3

NCCN Preferred NCCN Preferred Osimertinib (TAGRISSO) is the only National Comprehensive Cancer Network® (NCCN®) preferred first-line therapy option in metastatic EGFRm NSCLC.4*
*The NCCN Guidelines® for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques, but do not endorse any specific commercially available biomarker assays.

Durable responses in overall study population1

Durable responses in overall study population1

  • Nearly 8 of 10 patients had a tumor response to first-line TAGRISSO (ORR 77% [95% CI: 71, 82] for TAGRISSO and 69% [95% CI: 63, 74] for EGFR-TKI comparator)
  • Median duration of response was 17.6 months (95% CI: 13.8, 22.0) for first-line TAGRISSO and 9.6 months (95% CI: 8.3, 11.1) for EGFR-TKI comparator

In metastatic EGFRm NSCLC

First-line TAGRISSO: Significantly reduced risk of CNS progression or death by 52%5*

Median CNS PFS not reached with first-line TAGRISSO (95% CI: 16.5, NC) vs 13.9 months (95% CI: 8.3, NC) for EGFR-TKI comparator

  • CNS PFS results only take into account progression in the CNS

CNS PFS IN METASTATIC EGFRm NSCLC PATIENTS WITH CNS METASTASES AT BASELINE

TAGRISSO (osimertinib) CNS PFS in metastatic EGFRm NSCLC patients with CNS metastases at baseline TAGRISSO (osimertinib) CNS PFS in metastatic EGFRm NSCLC patients with CNS metastases at baseline

NC=not calculable.

*This was a preplanned exploratory analysis. Based on investigator assessment. Progression events that do not occur within 2 scheduled visits of the last evaluable assessment or randomization, are censored and therefore excluded in the number of events (excluding deaths). Total rate of CNS progression in the full study population, irrespective of CNS lesion status at baseline. TAGRISSO, n=279; erlotinib/gefitinib, n=277. Total number of patients who experienced progression TAGRISSO: n=17; erlotinib/gefitinib, n=42.5-7

CNS response rates1

CNS ORR by BICR in patients with measurable CNS lesions at baseline1

CNS Overall response rates in FLAURA CNS Overall response rates in FLAURA

Approximately 1 in 5 patients with measurable CNS metastases experienced CNS complete response with first-line TAGRISSO

FLAURA: A phase 3, double-blind, randomized trial1,2,5,7

FLAURA: A phase 3, double-blind, randomized trial1,2,5,7 FLAURA: A phase 3, double-blind, randomized trial1,2,5,7

Crossover was allowed for patients in the EGFR-TKI comparator arm upon confirmed progression and EGFR T790M positivity

Primary endpoint: PFS based on investigator assessment (according to RECIST v1.1).

Secondary endpoints: Overall Survival, overall response rate, CNS PFS, and duration of response.

  • The two endpoints of OS and CNS PFS were tested after the primary PFS analysis in a hierarchical procedure at the time of PFS analysis, following primary analysis
*Patients received either erlotinib or gefitinib as the sole comparator preselected by the trial site. All US patients in the comparator arm received erlotinib.2RECIST v1.1 assessment every 6 weeks (±1 week) until objective progressive disease. Every 12 weeks (±1 week) after 18 months.2

A hierarchical procedure was used to adjust for multiplicity in testing the key endpoints of PFS, OS, and CNS PFS. To provide strong control for the type I error rate, the primary endpoint of PFS and endpoints of OS and CNS PFS were tested sequentially.5

Go to FLAURA study design on ClinicalTrials.gov

Patient characteristics

FLAURA BASELINE DEMOGRAPHICS1,7

TAGRISSO (osimertinib) FLAURA patient baseline demographics1,7 TAGRISSO (osimertinib) FLAURA patient baseline demographics1,7

§Includes extrathoracic metastases.||Identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases.

See TAGRISSO efficacy in
resected EGFRm NSCLC

BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation positive; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; po, by mouth; PS, performance status; qd, once daily; RECIST, Response Evaluation Criteria In Solid Tumors; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor; WHO, World Health Organization.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125 [protocol]. 3. Ramalingam SS, Vansteenkiste J, Planchard D, et al; FLAURA Investigators. Overall survival with osimertinib in untreated EGFR-mutated advanced NSCLC. N Engl J Med. 2020;382(1):41-50. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.2.2021. ©National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed December 15, 2020. 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. Reungwetwattana T, Nakagawa K, Cho BC, et al; CNS response to osimertinib versus standard epidermal growth factor receptor tyrosine kinase inhibitors in patients with untreated EGFR-mutated advanced non-small cell lung cancer. J Clin Oncol. 2018. doi:10.1200/JCO.2018.78.3118. [Epub ahead of print.] 6. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125 [supplementary appendix]. 7. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125.

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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