{"id":11542,"date":"2022-09-05T14:39:00","date_gmt":"2022-09-05T14:39:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3863218_CN63218_0"},"modified":"2022-09-05T14:39:00","modified_gmt":"2022-09-05T14:39:00","slug":"dizal-announces-positive-phase-i-clinical-trial-results-for-dzd1516-in-treating-her2-breast-cancer-at-2022-esmo","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=11542","title":{"rendered":"Dizal Announces Positive Phase I Clinical Trial Results for DZD1516 in Treating HER2 Breast Cancer at 2022 ESMO"},"content":{"rendered":"<p><span class=\"legendSpanClass\"><span class=\"xn-location\">PARIS<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Sept. 5, 2022<\/span><\/span> \/PRNewswire\/ &#8212; Dizal reported the promising safety and pharmacokinetic data from the global Phase I study of <span class=\"xn-money\">DZD1516<\/span> in patients with HER2 positive metastatic breast cancer (HER2+ MBC) who relapsed from multiple prior treatments at the 2022 European Society for Medical Oncology Annual Meetin<span id=\"spanHghlt836a\">g.<\/span><\/p>\n<p>Nearly 60% of patients with advanced HER2-positive breast cancer develop brain metastasis and the prognosis is extremely poor. <span class=\"xn-money\">DZD1516<\/span> is an oral, full blood-brain barrier (BBB) penetrant selective HER2 inhibitor for the treatment of HER2-positive metastatic breast cancer.<\/p>\n<p>The Phase I study is enrolling HER2+ MBC patients who relapsed from or were intolerant to the standard of care (SoC). The primary objective is to evaluate the safety of <span class=\"xn-money\">DZD1516<\/span> and to define maximum tolerated dose (MTD). As of <span class=\"xn-chron\">February 20, 2022<\/span>, <span class=\"xn-money\">DZD1516<\/span> was explored in 22 HER2+ MBC patients from the <span class=\"xn-location\">USA<\/span> and <span class=\"xn-location\">China<\/span>, among whom nearly 70% had CNS metastases at baseline. Key findings are as follows:<\/p>\n<ul type=\"disc\">\n<li><span class=\"xn-money\">DZD1516<\/span> was well tolerated at doses \u2264 250 mg, and in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. Thus, 250 mg was defined as MTD.<\/li>\n<li>In patients, mean K<sub>puu,CSF <\/sub>was 2.1 for <span class=\"xn-money\">DZD1516<\/span> across the dose range, indicating full penetration of <span class=\"xn-money\">DZD1516<\/span> through human BBB.<\/li>\n<li>18 patients had completed \u2265 1 post treatment RECIST assessment. With a median of 7 lines of prior systemic treatment (86% treated with HER2 TKI), the best antitumor efficacy in intracranial, extracranial and overall lesions was stable disease.<\/li>\n<\/ul>\n<p>&#8220;Patients with HER2 positive breast cancer and brain metastasis have poor outcomes due to the limited therapies,&#8221; said Dr. <span class=\"xn-person\">Xiaolin Zhang<\/span>, CEO of Dizal, &#8220;Based on these promising findings, we will further explore the potential of <span class=\"xn-money\">DZD1516<\/span> as a new treatment option for&nbsp;this underserved patient population.&#8221;<\/p>\n<p><b>About 1516<\/b><\/p>\n<p><span class=\"xn-money\">DZD1516<\/span> is designed as an oral, potent, reversible, highly selective, and full blood-brain barrier (BBB) penetrant HER2 tyrosine kinase inhibitor (TKI), with more than 300-fold selectivity for HER2 compared to wild-type EGFR. It is well tolerated at doses \u2264 250 mg, twice daily. And in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. In patients, mean K<sub>puu,CSF <\/sub>is 2.1 for <span class=\"xn-money\">DZD1516<\/span> across the dose range, indicating full penetration of <span class=\"xn-money\">DZD1516<\/span> through human BBB.<\/p>\n<p><b>About Dizal<\/b><\/p>\n<p>Dizal is a clinical-stage, biopharmaceutical company, dedicated to the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies.<\/p>\n<p><b>About ESMO<\/b><\/p>\n<p>The European Society for Medical Oncology (ESMO) is the leading professional organization for medical oncology. With more than 25,000 members representing oncology professionals from over 160 countries worldwide, ESMO is the society of reference for oncology education and information. Found in 1975, ESMO&#8217;s core mission is to improve the quality of cancer care, from prevention and diagnosis all the way to palliative care and patient follow-up. And it is to promote equal access to optimal cancer care for all patients. The 2022 annual ESMO Congress will be held in <span class=\"xn-location\">Paris, France<\/span>, online and offline from 9-13 September. The congress presents the latest scientific developments in basic, translational and clinical cancer research and contextualizes new findings for practical implementation in everyday patient care.<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words &#8220;anticipate&#8221;, &#8220;believe&#8221;, &#8220;estimate&#8221;, &#8220;expect&#8221;, and &#8220;intend&#8221; and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.<\/p>\n<p>These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal&#8217;s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal&#8217;s competitive environment, and political, economic, legal, and social conditions.<\/p>\n<p>Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.<\/p>\n<p id=\"PURL\"><img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CN63218&amp;sd=2022-09-05\"> View original content:<a id=\"PRNURL\" rel=\"nofollow noopener\" href=\"https:\/\/www.prnewswire.com\/news-releases\/dizal-announces-positive-phase-i-clinical-trial-results-for-dzd1516-in-treating-her2-breast-cancer-at-2022-esmo-301617826.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/dizal-announces-positive-phase-i-clinical-trial-results-for-dzd1516-in-treating-her2-breast-cancer-at-2022-esmo-301617826.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PARIS, Sept. 5, 2022 \/PRNewswire\/ &#8212; Dizal reported the promising safety and pharmacokinetic data from the global Phase I study of DZD1516 in patients with HER2 positive metastatic breast cancer (HER2+ MBC) who relapsed from multiple prior treatments at the 2022 European Society for Medical Oncology Annual Meeting. Nearly 60% of patients with advanced HER2-positive [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-11542","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dizal Announces Positive Phase I Clinical Trial Results for DZD1516 in Treating HER2 Breast Cancer at 2022 ESMO - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=11542\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dizal Announces Positive Phase I Clinical Trial Results for DZD1516 in Treating HER2 Breast Cancer at 2022 ESMO - My Blog\" \/>\n<meta property=\"og:description\" content=\"PARIS, Sept. 5, 2022 \/PRNewswire\/ &#8212; Dizal reported the promising safety and pharmacokinetic data from the global Phase I study of DZD1516 in patients with HER2 positive metastatic breast cancer (HER2+ MBC) who relapsed from multiple prior treatments at the 2022 European Society for Medical Oncology Annual Meeting. 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