Clinical Trials

<!DOCTYPE html> <html lang="en"> <head> <title>Clinical Trials</title> <meta name="description" content="Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous), and PB357 in 2011. In 2022, Puma in-licensed global research and development and commercial rights to alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Puma has been focused on developing the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. Puma believes that neratinib has clinical applications in the treatment of several other cancers as well, including non-small cell lung cancer and other solid tumor types that over-express or have a mutation in HER2. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. Puma commenced commercial sales of the drug in 2017 and it is marketed in the United States as NERLYNX® tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. Commercial sales commenced in the European Union in 2019. Puma has entered into additional exclusive license agreements with various parties to commercialize NERLYNX in regions outside the United States, including the European Union, Canada, Latin America, Greater China, Israel, Southeast Asia, Australia, New Zealand, South Korea, the Middle East, and parts of Africa. Puma plans to continue to pursue the commercialization of NERLYNX outside the United States. Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in Clinical Trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia. Puma initially intends to focus the development of alisertib on the treatment of patients with metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer. Alan H. Auerbach has served as Chairman of the Board, CEO and President of Puma Biotechnology, Inc. since he founded the Company in 2010. Prior to Puma, Mr. Auerbach served as CEO, President and a Member of the Board of Directors of Cougar Biotechnology, Inc., from its inception in 2003 until its acquisition by Johnson & Johnson in July 2009. From July 2009 until January 2010, Mr. Auerbach served as Co-Chairman of the Integration Steering Committee at Cougar (as part of J&J), providing leadership and oversight for the development and global commercialization of Cougar's lead product candidate, abiraterone acetate. Abiraterone (Zytiga) was approved for the treatment of metastatic prostate cancer in the U.S. in April 2011 and in the EU in September 2011. Prior to founding Cougar, from June 1998 to April 2003 Mr. Auerbach was Vice President, Senior Research Analyst at Wells Fargo Securities, where he was responsible for research coverage of small- and mid-cap biotechnology companies, with a focus on oncology. He had primary responsibility for technical, scientific and clinical due diligence, and selected biotechnology companies followed by the company. In 2002, Mr. Auerbach ranked second in the NASDAQ/Starmine survey of analyst performance for stock picking in biotechnology. From August 1997 to May 1998, Mr. Auerbach was Vice President, Research Analyst at the Seidler Companies, Inc., where he was responsible for research coverage of small-cap biotechnology companies. Prior to his work as a securities analyst, Mr. Auerbach worked for Diagnostic Products Corporation, where he designed and implemented Clinical Trials in the field of oncology. Mr. Auerbach received a B.S. in Biomedical Engineering from Boston University and an M.S. in Biomedical Engineering from the University of Southern California. Puma Biotechnology, Inc., founded in 2010, is headquartered in Los Angeles, California. Additional information may be found at https://www.pumabiotechnology.com. NERLYNX® is a registered trademark of Puma Biotechnology, Inc." /> <meta name="keywords" content="Puma Biotechnology, biotechnology, nerlynx, neratinib, neratinib tablets, breast cancer, early stage, metastatic, drug development, pb272, Clinical Trials, oncology, her2+, biopharmaceutical, in-licensing, cancer treatment, oncology, extended adjuvant therapy, non-small cell lung cancer, biliary cancer, ExteNET, SUMMIT, FB-10 , CONTROL, NALA, tyrosine kinase inhibitor, TBCRC-022, HER2-mutated, EGFR, EGFR exon 18, EGFR exon 18-mutant, HER-Seq, alisertib, aurora kinase A, adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A, inhibitor of aurora kinase A, disruption of mitosis, apoptosis of rapidly proliferating tumor cells, apoptosis of tumor cells, breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma, acute myeloid leukemia, metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer, HER2-negative breast cancer, ER-positive breast cancer" /> <meta name="author" content="Puma Biotechnology, Inc." /> <meta charset="UTF-8" /> <meta name="format-detection" content="telephone=no" /> <link rel="stylesheet" href="../css/style.min.css?_v=20240926104104" /> <link rel="shortcut icon" href="../favicon.ico" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script async src="https://kit.fontawesome.com/ee8e128eea.js" crossorigin="anonymous"></script> </head>  <script async src="https://www.googletagmanager.com/gtag/js?id=G-CN3D3P6NW6"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'G-CN3D3P6NW6'); </script> <script> const PATH = '../img/'; </script> <body> <div class="wrapper"> <header class="header" data-lp> <div class="header__container"> <div class="header__content"> <a href="../index.html" class="header__logo"> <picture> 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class="hero__body"> <div class="hero__info"> <h3 class="hero__title">Our Mission</h3> <p class="hero__descr">Puma Biotechnology is a biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel therapeutics for the treatment of cancer.</p> </div> <div class="hero__bg-image"> <img src="../img/hero/hero_bg-03.png" data-no-lazy decoding="async" width="1440" height="697" alt="" /> </div> </div> </div> </section>  <section class="page__investors investors"> <div class="investors__container"> <h2 class="investors__title">Clinical Trials</h2> <div class="investors__body"> <nav class="investors__navigation"> <a href="./clinincal_trials.html" class="investors__nav-button">Clinical Trials</a> <a href="./alisca_lung1.html" class="investors__nav-button">ALISCA™-Lung1</a> <a href="./alisca_breast1.html" class="investors__nav-button _tab-active">ALISCA™-Breast1</a> <a href="./cds.html" class="investors__nav-button">Clinical Trial Data Sharing</a> <a href="./eap.html" class="investors__nav-button">Extended Access Program</a> </nav> <div class="investors__content"> <div class="investors__block"> <div class="alisca-lung"> <div class="alisca-lung__top-row"> <h2 class="investors__title alisca-lung__title">ALISCA™-Breast1</h2> <p class="alisca-lung__descr"> In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, an investigational, selective, small molecule, orally administered inhibitor of Aurora Kinase A. In March 2024, Puma received FDA approval to proceed with our Phase II ALISCA™-Breast1 trial of alisertib for the treatment of hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer. </p> </div> <div class="alisca-lung__body"> <div class="alisca-lung__block"> <h3 class="alisca-lung__headline alisca-lung__headline--orange">Metastatic Breast Cancer</h3> <div class="alisca-lung__content"> <h3>ALISCA™-Breast1</h3> <p> A Phase II Study of Alisertib, an Investigational Drug, in Combination with Endocrine Therapy in Patients with HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. </p> <h3>ABOUT THIS CLINICAL TRIAL</h3> <p> This Phase II study is investigating alisertib in combination with endocrine therapy in patients with HR+, HER2-negative metastatic breast cancer (MBC). Findings from this study are anticipated to identify the optimal alisertib dose level administered in combination with selected endocrine therapy to be used in future studies based on safety and efficacy, as well as identify a biomarker subpopulation of patients who derive the greatest benefit from combined alisertib and endocrine therapy. </p> <h3>WHO IS ELIGIBLE?</h3> <p> The ALISCA™-Breast1 clinical trial is open to patients 18 years or older with pathologically confirmed recurrent or metastatic HR+, HER2-negative breast cancer who have received at least two prior lines of endocrine therapy including a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting, but who have not received chemotherapy in the recurrent or metastatic setting. Talk to your doctor to discuss your eligibility. </p> <h3>NOW ENROLLING</h3> <p>Puma anticipates opening the ALISCA™-Breast1 trial at approximately 50 study sites within the United States and Europe. <a href="alisca_breast1_sites.html"><b>Click here</b></a> for a list of study sites currently open to enrollment.</p> <p>FOR MORE INFORMATION ON THIS CLINICAL TRIAL AND LOCATION OF <a href="alisca_breast1_sites.html"><b>TRIAL SITES:</b></a></p> </div>     <button type="button" class="alisca-lung__button alisca-lung__button--aligned-left button" data-popup=".third-website" data-popup-redirect="https://clinicaltrials.gov/study/NCT06369285?term=puma-ali-1201&rank=1"> <span >VISIT CLINICALTRIALS.GOV <br /> ID NCT06369285 </span> <i class="fa-solid fa-laptop-code"></i> </button>  <p class="alisca-lung__text">or email <a href="mailto:clinicaltrials@pumabiotechnology.com">clinicaltrials@pumabiotechnology.com</a></p>  </div> <div class="alisca-lung__block"> <h3 class="alisca-lung__headline alisca-lung__headline--blue">Download</h3> <div class="alisca-download"> <div class="alisca-download__image"> <img src="../img/gallery/pr-08.png" width="708" height="360" alt="Awesome image" /> </div> <div class="alisca-download__cols"> <a href="../docs/2024/alisca_breast1_trial_information_sheet_20240523.pdf" class="alisca-download__col"> <h3 class="alisca-download__label"> CLINICAL TRIAL <br /> INFORMATION SHEET </h3> <i class="fa-solid fa-file-arrow-down"></i> </a> <a href="../docs/2024/alisca_breast1_questions_for_oncologist_20240523.pdf" class="alisca-download__col"> <h3 class="alisca-download__label"> QUESTIONS TO ASK <br /> YOUR ONCOLOGIST </h3> <i class="fa-solid fa-file-arrow-down"></i> </a> </div> </div> </div>       </div> </div> </div> </div> </div> </div> </section>  <button type="button" class="back-top" data-goto=".wrapper"> <div class="back-top__icon"><i class="fa-solid fa-arrow-up"></i></div> <span class="back-top__text">Back to top</span> </button> </main> <footer 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Clinical Trials