
In a global, Phase III study in metastatic EGFRm NSCLC
Patients were progression free almost twice as long vs erlotinib/gefitinib1
In a global, Phase III study in metastatic EGFRm NSCLC
Patients' median Overall Survival was beyond 3 years for patients on TAGRISSO2
In a global, Phase III study in metastatic EGFRm NSCLC
First-line TAGRISSO reduced the risk of CNS progression in patients with CNS metastases at baseline by 52% vs erlotinib/gefitinib; HR=0.48 (95% CI: 0.26, 0.86); P=0.0144
Results from patients with CNS metastases at baseline1
FLAURA study design: Randomized, double-blind, active-controlled trial in 556 patients with metastatic EGFRm NSCLC who had not received prior systemic treatment for advanced disease. Patients were randomized 1:1 to either TAGRISSO (n=279; 80 mg orally, once daily) or EGFR-TKI comparator (n=277; gefitinib 250 mg or erlotinib 150 mg orally, once daily). All US patients in the comparator arm received erlotinib. Crossover was allowed for patients in the EGFR-TKI comparator arm at confirmed progression if positive for the EGFR T790M resistance mutation. Patients with CNS metastases not requiring steroids and with stable neurologic status were included in the study. The primary endpoint of the study was PFS based on investigator assessment (according to RECIST v1.1). Secondary endpoints included OS, ORR, CNS PFS, and DoR.1,4-6†
†A hierarchic 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.4
CI, confidence interval; CNS, central nervous system; DoR, duration of response; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; HR, hazard ratio; NC, not calculable; NSCLC, non-small cell lung cancer; OS, Overall Survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria In Solid Tumors; TKI, tyrosine kinase inhibitor.
References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): final overall survival analysis [oral presentation]. Presented at: European Society of Medical Oncology; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA5. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.6.2020. ©National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed June 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. 4. 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.] 5. 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]. 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.
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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