Kazia Therapeutics Announces Presentation of Promising Phase I Data Evaluating Concurrent Paxalisib and Radiation Therapy in Patients with Solid Tumor Brain Metastases or Leptomeningeal Metastases Harboring PI3K Pathway Mutations at the American Society for Radiation Oncology 66th Annual Meeting

PR Newswire10-02

Treatment with 45mg paxalisib and radiotherapy demonstrated 67% partial response (PR) Over two-thirds of the patients at maximum tolerated dose (MTD) achieved intracranial response which compares ...

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Over two-thirds of the patients at maximum tolerated dose  achieved intracranial response which compares favorably to historical response rates for whole brain radiation therapy alone. SYDNEY, Oct. 2, 2024 /PRNewswire/ -- Kazia Therapeutics Limited , an oncology-focused drug development company, announced the presentation of data from a Phase I study  evaluating concurrent paxalisib and radiation therapy  in patients for the treatment of solid tumor brain metastases  or leptomeningeal metastases  harboring PI3K pathway mutations at the American Society for Radiation Oncology 66th Annual Meeting , which is taking place from September 29 - October 2, 2024, in Washington, D.C.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4588":"碎股","PR":"Permian Resources Corp","BK4117":"多元化保险","LU0347712357.USD":"BNP PARIBAS GLOBAL ENVIRONMENT \"C\" (USD) ACC","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","BK4548":"巴美列捷福持仓","LU2413666699.HKD":"BNP PARIBAS GLOBAL ENVIRONMENT \"CRH\" (HKDHDG) INC","BK4213":"石油与天然气的勘探与生产","BK4107":"财产与意外伤害保险","LU2413666426.HKD":"BNP PARIBAS GLOBAL ENVIRONMENT \"C\" (HKD) ACC","SRS":"两倍做空房地产ETF-ProShares","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","BK4567":"ESG概念","BK4585":"ETF&股票定投概念","KZIA":"Kazia Therapeutics Limited","BK4139":"生物科技","BK4533":"AQR资本管理(全球第二大对冲基金)","MTD":"梅特勒-托利多","AFG":"美国金融集团有限公司","LU1721428933.USD":"法巴全球经典环境基金RH MD Dis","LENZ":"Therapeutics","BK4121":"生命科学工具和服务"},"translate_title":"Kazia Therapeutics宣布在美国放射肿瘤学会第66届年会上展示有希望的I期数据，评估Paxalisib和放射治疗同时治疗携带PI3K途径突变的实体瘤脑转移或软脑膜转移患者","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SRS":1,"PR":1,"MTD":1,"LENZ":1,"AFG":1,"KZIA":0.9},"content_text":"Treatment with 45mg paxalisib and radiotherapy demonstrated 67% partial response (PR)\nOver two-thirds of the patients at maximum tolerated dose (MTD) achieved intracranial response which compares favorably to historical response rates for whole brain radiation therapy alone\nSYDNEY, Oct. 2, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, announced the presentation of data from a Phase I study (NCT04192981) evaluating concurrent paxalisib and radiation therapy (RT) in patients for the treatment of solid tumor brain metastases (BM) or leptomeningeal metastases (LM) harboring PI3K pathway mutations at the American Society for Radiation Oncology 66th Annual Meeting (ASTRO 2024), which is taking place from September 29 - October 2, 2024, in Washington, D.C.\n\n  \n\n\"The encouraging response rates observed from this Phase 1 study suggests that the concurrent administration of the investigational brain penetrant PI3K inhibitor, paxalisib, in combination radiation therapy appears to be a viable treatment approach for addressing the tumor radioresistance in patients harboring PI3K pathway mutations,\" said John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. \"Additional data, including circulating tumor DNA (ctDNA) from this study will be presented at an upcoming 2024 scientific congress and discussions for a potential pivotal registration study to evaluate this unique combination therapy for patients with PI3K mutant brain metastases are ongoing.\"\n\n\n\n\nPresentation details: \n\n\n\nTitle: \nMulti-Center Phase I Study of Concurrent Paxalisib and Radiation Therapy in Patients with Solid Tumor Brain Metastases (BM) or Leptomeningeal Metastases (LM) Harboring PI3K Pathway Mutations \n\n\nPresenter: \nBrandon S. Imber, M.D., M.A., Memorial Sloan Kettering Cancer Center \n\n\nAbstract    \n1094 \n\n\nScientific Session Title: \nCNS 4: Brain Mets and LMD \n\n\nSession Date/Time: \nOctober 1, 5:15-6:15 PM ET \n\n\n\n\nSummary Results from Part II of Phase 1 Study\n\nConcurrent daily administration of paxalisib with brain radiotherapy was generally well-tolerated at a maximum dose of 45 mg per day in advanced solid tumor patients with brain metastases and PI3K pathway mutations;\nThe most commonly reported adverse events in the study were nausea, vomiting and hyperglycemia;\nEstablished proof-of-principle for molecularly-selected, rational combination studies in radiation oncology to assess safety and ultimately efficacy;\nTreatment with 45mg paxalisib and radiotherapy demonstrated a 67% PR; and\nOver two-thirds of the patients at MTD achieved intracranial response which compares favorably to historical response rates for WBRT alone.\n\nThe Phase 1 study (n=17 evaluable) was a two-part, investigator-initiated trial evaluating the use of paxalisib with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors. Part I of the study established the MTD of paxalisib in combination with radiation therapy, while also demonstrating promising signs of clinical activity in all nine evaluable patients. Part II was a follow-on expansion cohort to further evaluate safety and efficacy of the MTD (45mg daily) combined with radiation therapy in up to 12 additional patients.\nApproximately 200,000 cancer patients develop brain metastases in the United States each year. Radiotherapy is the mainstay of treatment for brain metastases, and generally consists of either stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT) or some combination thereof. The efficacy in patients who receive WBRT differs according to the type of tumor and the number and volume of brain metastases, but several recent publications cite overall response rates of 20-45%. The increasing incidence of brain metastasis and the low response rates to existing treatments underscores the need for new treatment options.\nAbout Kazia Therapeutics Limited \nKazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia.\nOur lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data.\nPaxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively.\nKazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit www.kaziatherapeutics.com  or follow us on X @KaziaTx.\nForward-Looking Statements \nThis announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as \"may,\" \"will,\" \"estimate,\" \"future,\" \"forward,\" \"anticipate,\" or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, the potential benefits of paxalisib as an investigational PI3K/mTOR inhibitor, timing for any regulatory submissions or discussions with regulatory agencies, and the potential market opportunity for paxalisib. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.\nThis announcement was authorized for release by Dr John Friend, CEO.\n View original content to download multimedia:https://www.prnewswire.com/news-releases/kazia-therapeutics-announces-presentation-of-promising-phase-i-data-evaluating-concurrent-paxalisib-and-radiation-therapy-in-patients-with-solid-tumor-brain-metastases-or-leptomeningeal-metastases-harboring-pi3k-pathway-mutations--302265538.html\nSOURCE Kazia Therapeutics Limited","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2472540268"}