{"id":7294,"date":"2018-02-23T12:12:05","date_gmt":"2018-02-23T20:12:05","guid":{"rendered":"https:\/\/sfj-pharma.com\/?p=7294"},"modified":"2021-05-13T14:30:10","modified_gmt":"2021-05-13T22:30:10","slug":"dacomitinib-daco-versus-gefitinib-gef-for-first-line-treatment-of-advanced-nsclc-archer-1050-final-overall-survival-os-analysis","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/dacomitinib-daco-versus-gefitinib-gef-for-first-line-treatment-of-advanced-nsclc-archer-1050-final-overall-survival-os-analysis\/","title":{"rendered":"Dacomitinib (daco) versus gefitinib (gef) for first-line treatment of advanced NSCLC (ARCHER 1050): Final overall survival (OS) analysis"},"content":{"rendered":"<p><b>Background:<\/b>In the ongoing phase 3 ARCHER 1050 study, first-line treatment with daco significantly improved the primary endpoint of progression-free survival, duration of response, and time to treatment failure vs gef in patients (pts) with epidermal growth factor receptor (<i>EGFR<\/i>) mutation-positive advanced non-small cell lung cancer (NSCLC) (Wu et al, <i>Lancet Oncol<\/i>, 2017). Here, we present the OS results.<\/p>\n<p><b>Methods:<\/b>Pts with newly diagnosed stage IIIB\/IV or recurrent NSCLC harboring an <i>EGFR<\/i> mutation (exon 19 del or exon 21 L858R \u00b1 exon 20 T790M) and without central nervous system metastasis were randomized 1:1 to oral daco 45 mg\/day or oral gef 250 mg\/day. Pts were stratified by race and <i>EGFR<\/i> mutation type.<\/p>\n<p><b>Results:<\/b>As of 17 February 2017, a total of 220 deaths (48.7%) occurred over a median follow-up of 31.3 months (mo): 103 (45.4%) in the daco arm (n = 227) and 117 (52.0%) in the gef arm (n = 225). Daco showed a significant improvement in OS compared to gef (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.582\u20130.993; 2-sided <i>P<\/i>= 0.044 based on stratified analysis). Median OS (95% CI) was 34.1 mo (29.5\u201337.7) with daco vs 26.8 mo (23.7\u201332.1) with gef. Survival rates at 30 mo were 56.2% with daco and 46.3% with gef. The table shows preliminary OS subgroup analyses by race and <i>EGFR<\/i> mutation type, with &gt;55% of pts being censored in some subsets. OS subgroup analyses were consistent with the primary OS analysis across most baseline characteristics.<\/p>\n<p><b>Conclusions:<\/b>In pts with advanced <i>EGFR<\/i> mutation-positive NSCLC, daco is the first to show a significant improvement in OS in a phase 3 trial compared with a standard-of-care tyrosine kinase inhibitor. Daco should be considered as one of the standard treatment options for these pts. Clinical trial information: <a href=\"http:\/\/clinicaltrials.gov\/show\/NCT01774721\">NCT01774721<\/a><\/p>\n<p><a href=\"https:\/\/meetinglibrary.asco.org\/record\/161487\/abstract\" target=\"_blank\" rel=\"noopener noreferrer\">View full article on ASCO Meeting Library.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Background:In the ongoing phase 3 ARCHER 1050 study, first-line treatment with daco significantly improved the primary endpoint of progression-free survival, duration of response, and time to treatment failure vs gef in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer&#8230;<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7294","post","type-post","status-publish","format-standard","hentry","category-scientific-publications"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - 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