{"id":55904,"date":"2023-04-17T20:04:06","date_gmt":"2023-04-17T18:04:06","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/avistone-announces-interim-data-results-on-plb1004-in-patients-with-egfr-mutant-nsclc-patients-at-aacr-2023\/"},"modified":"2023-04-17T20:04:06","modified_gmt":"2023-04-17T18:04:06","slug":"avistone-announces-interim-data-results-on-plb1004-in-patients-with-egfr-mutant-nsclc-patients-at-aacr-2023","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/avistone-announces-interim-data-results-on-plb1004-in-patients-with-egfr-mutant-nsclc-patients-at-aacr-2023\/","title":{"rendered":"Avistone Announces Interim Data Results on PLB1004 in Patients with EGFR mutant NSCLC Patients at AACR 2023"},"content":{"rendered":"<div>\n<p>BEIJING&#8211;(BUSINESS WIRE)&#8211;Avistone Biotechnology (\u201cAvistone\u201d or \u201cthe Company\u201d), a clinical-stage biotechnology company focused on precision oncology therapeutics, today announced interim results from its ongoing phase 1 study on PLB1004. The data were presented today (CT102) at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida USA.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230417005163\/en\/1764470\/5\/MicrosoftTeams-image_%284%29.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230417005163\/en\/1764470\/21\/MicrosoftTeams-image_%284%29.jpg\"><\/a><\/p>\n<p>\nPLB1004, a novel mono-anilino-pyrimidine small molecule inhibitor of EGFR, potently and irreversibly targets exon 20 insertion. The molecule also potently targets classical EGFR mutations ExDel19, L858R and T790M with a high degree of selectivity over wild-type EGFR.<\/p>\n<p>\nThe study is a multi-center, open-label, dose escalation and expansion study conducted entirely in China, to assess the safety, tolerability, pharmacokinetics, and anti-tumor effect of PLB1004, administered orally, in patients with advanced non-small cell lung cancer. The primary objective of the study is to assess the safety profile of PLB1004 and determine the RP2D of the molecule.<\/p>\n<p>\nAt the cutoff date for these interim results, July 31, 2022, a total of 65 patients (32 in escalation and 33 in expansion) had received treatment with PLB1004. Dose escalation ranged from a starting dose of 10 mg QD to a top dose of 480 mg QD in 11 cohorts of patients. As of July 31, 2022, dose expansion occurred at two dose levels, 320 mg QD and 400 mg QD. The median age of the patients is 58 years old (range 31 to 77). Most patients are women (60%) with adenocarcinoma (95%) and good performance status (ECOG 0-1 in 98%). The most frequent treatment related adverse events included diarrhea in 75% of patients (19% Grade 3), rash in 60% of patients (11% Grade 3), mouth ulceration in 43% of patients (1.5% Grade 3), elevated serum creatinine in 43% of patients (2% Grade 3) and elevated aspartate aminotransferase in 41% of patients (3% Grade 3). No DLTs were observed at any dose level and thus an MTD was not determined during cycle 1 of drug administration. Beyond Cycle 1, at the highest dose levels, frequent dose interruptions and reductions due to toxicity were observed, and further dose escalation was not attempted above 480 mg QD. Across all dose groups, a total of 38 subjects had EGFR Ex20ins mutations, including 29 at doses \u2265 160 mg QD, among whom 26 completed at least 1 tumor assessment. In these 26 patients the confirmed best response rate was 57.7% (15\/26) and the disease control rate (DCR) was 100% (26\/26). Among the 26 patients (\u2265160mg QD dose level) with EGFR Ex20ins mutation who completed at least one tumor evaluation, 8 patients had brain metastases, and 3 of them had a PR (37.5%).<\/p>\n<p>\n\u201cPLB1004 appears to be safe and well-tolerated with promising anti-tumor activity in patients with NSCLC harboring EGFR exon 20 insertion mutations,\u201d said Jin-Ji Yang, M.D., Primary Investigator from Guangdong Provincial People\u2019s Hospital.<\/p>\n<p>\n\u201cAvistone is a science-driven, innovative biotechnology company committed to the discovery and clinical development of first-in-class and best-in-class drugs,\u201d said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. \u201cWe are proud to share data at this year\u2019s AACR conference for PLB1004 which has best-in-class potential for patients with EGFR NSCLC. We are excited to present these additional data and to highlight the advancements we are achieving for patients with lung cancer.\u201d<\/p>\n<p>\nElectronic copies of the poster presented at the AACR annual meeting are available upon request.<\/p>\n<p>\n<b>About Avistone Biotechnology<\/b><\/p>\n<p>\nAvistone is a clinical-stage biotechnology company based in Beijing, China, focusing on researching and developing innovative therapies for patients with significant unmet medical needs globally. The company\u2019s core team comprises experienced drug design and clinical development experts, supported by a scientific advisory committee that includes internationally renowned KOLs. Avistone has an extensive pipeline of targeted therapies for molecular drivers of cancer, including two clinical-stage drug candidates and several ongoing programs in the pre-clinical development stage.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nMedia: David Chung (<a target=\"_blank\" href=\"&#x6d;&#97;i&#x6c;&#x74;&#111;:&#x64;&#97;v&#x69;&#x64;&#46;c&#x68;&#117;n&#x67;&#x40;&#97;v&#x69;&#x73;&#116;&#x6f;&#x6e;&#101;b&#x69;&#x6f;&#46;c&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#100;a&#x76;i&#x64;&#46;&#x63;h&#x75;&#110;&#x67;&#64;&#x61;&#118;&#x69;&#115;t&#111;n&#x65;b&#x69;o&#x2e;&#99;&#x6f;&#109;<\/a>)<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>BEIJING&#8211;(BUSINESS WIRE)&#8211;Avistone Biotechnology (\u201cAvistone\u201d or \u201cthe Company\u201d), a clinical-stage biotechnology company focused on precision oncology therapeutics, today announced interim results from its ongoing phase 1 study on PLB1004. The data were presented today (CT102) at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida USA. PLB1004, a novel mono-anilino-pyrimidine small molecule &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/avistone-announces-interim-data-results-on-plb1004-in-patients-with-egfr-mutant-nsclc-patients-at-aacr-2023\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-55904","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Avistone Announces Interim Data Results on PLB1004 in Patients with EGFR mutant NSCLC Patients at AACR 2023 - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/avistone-announces-interim-data-results-on-plb1004-in-patients-with-egfr-mutant-nsclc-patients-at-aacr-2023\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Avistone Announces Interim Data Results on PLB1004 in Patients with EGFR mutant NSCLC Patients at AACR 2023 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BEIJING&#8211;(BUSINESS WIRE)&#8211;Avistone Biotechnology (\u201cAvistone\u201d or \u201cthe Company\u201d), a clinical-stage biotechnology company focused on precision oncology therapeutics, today announced interim results from its ongoing phase 1 study on PLB1004. 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