In metastatic EGFRm NSCLC
PFS IN THE PHASE 3 FLAURA STUDY
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
OVERALL SURVIVAL IN THE PHASE 3 FLAURA STUDY
At 3 years, 54% of TAGRISSO patients and 44% of EGFR-TKI comparator patients were still alive3
In metastatic EGFRm NSCLC
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 IN METASTATIC EGFRm NSCLC PATIENTS WITH CNS METASTASES AT BASELINE
*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
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.
‡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
FLAURA BASELINE DEMOGRAPHICS1,7
References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 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.
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
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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