Daiichi Sankyo Group Value Report 2019
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A Phase I Study of Pexidartinib, a Colony-Stimulating Factor 1 Receptor Inhibitor, in Asian Patients with Advanced Solid Tumors
Investigational New Drugs https://doi.org/10.1007/s10637-019-00745-z PHASE I STUDIES A phase I study of pexidartinib, a colony-stimulating factor 1 receptor inhibitor, in Asian patients with advanced solid tumors Jih-Hsiang Lee1 & Tom Wei-Wu Chen2 & Chih-Hung Hsu2,3 & Yu-Hsin Yen2 & James Chih-Hsin Yang2,3 & Ann-Lii Cheng2,3 & Shun-ichi Sasaki4 & LiYin (Lillian) Chiu5 & Masahiro Sugihara4 & Tomoko Ishizuka4 & Toshihiro Oguma4 & Naoyuki Tajima4 & Chia-Chi Lin2,6 Received: 15 January 2019 /Accepted: 7 February 2019 # The Author(s) 2019 Summary Background Pexidartinib, a novel, orally administered small-molecule tyrosine kinase inhibitor, has strong selectivity against colony- stimulating factor 1 receptor. This phase I, nonrandomized, open-label multiple-dose study evaluated pexidartinib safety and efficacy in Asian patients with symptomatic, advanced solid tumors. Materials and Methods Patients received pexidartinib: cohort 1, 600 mg/d; cohort 2, 1000 mg/d for 2 weeks, then 800 mg/d. Primary objectives assessed pexidartinib safety and tolerability, and determined the recommended phase 2 dose; secondary objectives evaluated efficacy and pharmacokinetic profile. Results All11patients(6males,5 females; median age 64, range 23–82; cohort 1 n = 3; cohort 2 n = 8) experienced at least one treatment-emergent adverse event; 5 experienced at least one grade ≥ 3 adverse event, most commonly (18%) for each of the following: increased aspartate aminotransfer- ase, blood alkaline phosphatase, gamma-glutamyl transferase, and anemia. Recommended phase 2 dose was 1000 mg/d for 2 weeks and800mg/dthereafter.Pexidartinibexposure,areaundertheplasmaconcentration-timecurvefromzeroto8h(AUC0-8h), and maximum observed plasma concentration (Cmax) increased on days 1 and 15 with increasing pexidartinib doses, and time at Cmax (Tmax) was consistent throughout all doses. -
Press Release
Press Release Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo’s HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201) Collaboration combines Daiichi Sankyo’s scientific and technological excellence with AstraZeneca’s global experience and resources in oncology to accelerate and expand the potential of [fam-] trastuzumab deruxtecan as monotherapy and combination therapy across a spectrum of HER2 expressing cancers AstraZeneca to pay Daiichi Sankyo up to $6.90 billion in total consideration, including $1.35 billion upfront payment and up to an additional $5.55 billion contingent upon achievement of future regulatory and sales milestones as well as other contingencies Companies to share equally development and commercialization costs as well as profits worldwide from [fam-] trastuzumab deruxtecan with Daiichi Sankyo maintaining exclusive rights in Japan Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates; AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia Tokyo, Munich and Basking Ridge, NJ – (March 28, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s lead antibody drug conjugate (ADC), [fam-] trastuzumab deruxtecan (DS-8201), currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer. Daiichi Sankyo and AstraZeneca will jointly develop and commercialize [fam-] trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. -
Daiichi Sankyo Company, Limited
[Translation] CONVOCATION NOTICE OF THE 14TH ORDINARY GENERAL MEETING OF SHAREHOLDERS For the Fiscal Year Ended March 31, 2019 Daiichi Sankyo Company, Limited *Note: This translation does not include pictures, charts etc. originally issued in the Japanese version. - 1 - [Translation] To Our Shareholders At the Daiichi Sankyo Group (“the Group”), we are proceeding with the initiatives of 4th mid- term business plan with the aim of becoming a “Global Pharma Innovator with Competitive Advantage in Oncology” as set forth in our 2025 Vision. In fiscal 2018, we made significant progress in developing new drugs in oncology area, including DS-8201, an antibody drug conjugates utilizing our proprietary technologies. In addition, we entered into a strategic collaboration agreement with AstraZeneca, which has strengths in the oncology business, for the global development and commercialization of DS-8201 in order to maximize its value. Furthermore, sales of mainstay products such as edoxaban, an anticoagulant which supports current earnings of the Group, were firm in Japan and overseas. The achievement of initial target of mid-term business plan for fiscal 2020 is expected to be delayed by two years due to failure of achievement of the plan for pain franchise business and additional investments in research and development. However, we are gaining confidence of achieving our 2025 Vision and accelerating growth in the future due to the significant improvement in the value of oncology area pipelines. We will continue to make every effort to achieve the goals of the Medium-Term Management Plan and 2025 Vision. I greatly appreciate your continued support in the future. -
The Tumor Microenvironment and Overcoming Immune Escape Arsen Osipov1, May Tun Saung1, Lei Zheng1 and Adrian G
Osipov et al. Journal for ImmunoTherapy of Cancer (2019) 7:224 https://doi.org/10.1186/s40425-019-0667-0 REVIEW Open Access Small molecule immunomodulation: the tumor microenvironment and overcoming immune escape Arsen Osipov1, May Tun Saung1, Lei Zheng1 and Adrian G. Murphy1,2* Abstract Immunotherapy has led to a paradigm shift in the treatment of many advanced malignancies. Despite the success in treatment of tumors like non-small cell lung cancer (NSCLC) and melanoma, checkpoint inhibition-based immunotherapy has limitations. Many tumors, such as pancreatic cancer, are less responsive to checkpoint inhibitors, where patients tend to have a limited duration of benefit and where clinical responses are more robust in patients who are positive for predictive biomarkers. One of the critical factors that influence the efficacy of immunotherapy is the tumor microenvironment (TME), which contains a heterogeneous composition of immunosuppressive cells. Myeloid-derived suppressor cells (MDSCs) and tumor-associated macrophages (TAMs) alter the immune landscape of the TME and serve as facilitators of tumor proliferation, metastatic growth and immunotherapy resistance. Small molecule inhibitors that target these components of the TME have been developed. This special issue review focuses on two promising classes of immunomodulatory small molecule inhibitors: colony stimulating factor-1 receptor (CSF-1R) and focal adhesion kinase (FAK). Small molecule inhibitors of CSF-1R reprogram the TME and TAMs, and lead to enhanced T-cell-mediated tumor eradication. FAK small molecule inhibitors decrease the infiltration MDSCs, TAMs and regulatory T-cells. Additionally, FAK inhibitors are implicated as modulators of stromal density and cancer stem cells, leading to a TME more conducive to an anti-tumor immune response. -
Convocation Notice of the 16Th Ordinary General Meeting of Shareholders
[Translation] CONVOCATION NOTICE OF THE 16TH ORDINARY GENERAL MEETING OF SHAREHOLDERS For the Fiscal Year Ended March 31, 2021 Daiichi Sankyo Company, Limited *Note: This translation does not include pictures, charts etc. originally issued in the Japanese version. [Translation] To Our Shareholders We sincerely appreciate the continuous kindness of our shareholders. In addition, we would like to express our deepest sympathies to those who passed away due to COVID-19, and thank the medical personnel who are close to those who are fighting illness and are making efforts in treatment. We will continue to devote ourselves to the research and development of vaccines and therapeutic agents. Our “Purpose” is to “contribute to the enrichment of quality of life around the world.” As a pharmaceutical company with strengths in science and technology, we continuously create innovative pharmaceuticals and provide pharmaceuticals that meet diverse medical needs to provide sustainable value to society. We were able to launch the anti-cancer drug “Enhertu”, which is an antibody-drug conjugate (ADC) that utilizes our unique technology, in Japan and Europe in fiscal 2020, following the launch in the U.S. in fiscal 2019. Subsequent ADCs such as Dato-DXd and HER3-DXd are also steadily developing. Now, we have newly established our 2030 Vision of being an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society,” and have established 5-Year Business Plan (fiscal 2021 to fiscal 2025) as a plan to realize our 2025 Vision, “Global Pharma Innovator with Competitive Advantage in Oncology.” By working together as a Daiichi Sankyo Group on 5-Year Business Plan toward the 2030 Vision, we aim to solve the social issues expected of our company and increase shareholder value. -
Targeted Therapies in Melanoma: Knowledge, Resistance And
ooggeenneessii iinn ss && rrcc aa MM CC uu tt ff aa Journal ofJournal of oo gg ll ee ee aa aa nn nn nn nn ee ee rr rr ss ss uu uu ii ii Colombino et al., J Carcinog Mutagen 2014, S4:S4 ss ss oo oo JJ JJ ISSN: 2157-2518 CarCarcinogenesiscinogenesis & Mutagenesis DOI: 10.4172/2157-2518.S4-004 Review Article Open Access Targeted Therapies in Melanoma: Knowledge, Resistance and Perspectives Maria Colombino1*, Maria Cristina Sini1, Amelia Lissia2, Antonio Cossu2, and Giuseppe Palmieri1 1Unit of Cancer Genetics, Institute of Biomolecular Chemistry (ICB), National Research Council (CNR), Italy 2University Hospital Health Unit - Azienda Ospedaliero Universitaria (AOU), Via Matteotti, 07100 Sassari, Italy *Corresponding author: Dr. Maria Colombino, Unit of Cancer Genetics, Institute of Biomolecular Chemistry (ICB), National Research Council (CNR), Traversa La Crucca, 3 - Baldinca Li Punti, 07100 Sassari, Italy, Tel. +39 079 2841239; Fax +39 079 2841299; E-mail: [email protected] Received date: Mar 18, 2014, Accepted date: May 25, 2014, Published date: May 31, 2014 Copyright: © 2014 Colombino M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Several molecular mechanisms appear to play a major role in melanoma genesis and progression. Current targeted therapies focus on contrasting the activation of RAS/RAF/MEK/ERK and, to a less extent, PI3K/AKT pathways. Development of inhibitors of key effectors (mainly, BRAF mutant and MEK) has significantly improved treatment of patients with advanced melanoma. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
Daiichi Sankyo Company, Limited
[Translation] CONVOCATION NOTICE OF THE 6TH ORDINARY GENERAL MEETING OF SHAREHOLDERS For the Fiscal Period Ended March 31, 2011 Daiichi Sankyo Company, Limited - 1 - [Translation] (Securities Identification Code 4568) May 31, 2011 To Shareholders, Daiichi Sankyo Company, Limited Joji Nakayama, Representative Director and President & CEO 5-1, Nihonbashi Honcho 3-chome, Chuo-ku, Tokyo, Japan CONVOCATION NOTICE OF THE 6TH ORDINARY GENERAL MEETING OF SHAREHOLDERS We wish to extend our deepest sympathy to all those who have suffered hardship from the Great East Japan Earthquake that occurred in March 2011. Daiichi Sankyo Company, Limited (“the Company”) respectfully requests your attendance at the 6th Ordinary General Meeting of Shareholders (“the Meeting”), which will be held as detailed below. If you will not be able to attend the Meeting, you may exercise your voting rights through either of the methods described below, in which case we ask that you please exercise your voting rights by 17:30 (within our business hours), Friday, June 24, 2011 (Japan Time), after examining the attached reference documents. [Exercise of Voting Rights by Mail] Please indicate your approval or disapproval for the proposals on the enclosed voting form and return the form to the Company. Please note that the form must be received by the Company no later than the above-mentioned deadline. [Exercise of Voting Rights on the Internet etc.] After examining “Information on Exercise of Voting Rights, etc.” on pages 57 and 58, please vote on the Internet at the dedicated voting website (http://www.evote.jp/) no later than the above-mentioned deadline. The Company is participating in the platform for electronic exercise of voting rights for institutional investors operated by ICJ Inc. -
Phase Ib Study of the Combination of Pexidartinib (PLX3397), a CSF-1R Inhibitor, and Paclitaxel in Patients with Advanced Solid
TAM0010.1177/1758835919854238Therapeutic Advances in Medical OncologyR Wesolowski, N Sharma 854238research-article20192019 Therapeutic Advances in Medical Oncology Original Research Ther Adv Med Oncol Phase Ib study of the combination of 2019, Vol. 11: 1 –13 DOI:https://doi.org/10.1177/1758835919854238 10.1177/ pexidartinib (PLX3397), a CSF-1R inhibitor, 1758835919854238https://doi.org/10.1177/1758835919854238 © The Author(s), 2019. Article reuse guidelines: and paclitaxel in patients with advanced sagepub.com/journals- solid tumors permissions Robert Wesolowski, Neelesh Sharma, Laura Reebel, Mary Beth Rodal, Alexandra Peck, Brian L. West, Adhirai Marimuthu, Paul Severson, David A. Karlin, Afshin Dowlati, Mai H. Le, Lisa M. Coussens and Hope S. Rugo Abstract Purpose: To evaluate the safety, recommended phase II dose (RP2D) and efficacy of pexidartinib, a colony stimulating factor receptor 1 (CSF-1R) inhibitor, in combination with weekly paclitaxel in patients with advanced solid tumors. Patients and Methods: In part 1 of this phase Ib study, 24 patients with advanced solid tumors received escalating doses of pexidartinib with weekly paclitaxel (80 mg/m2). Pexidartinib was administered at 600 mg/day in cohort 1. For subsequent cohorts, the dose was increased by ⩽50% using a standard 3+3 design. In part 2, 30 patients with metastatic solid tumors were enrolled to examine safety, tolerability and efficacy of the RP2D. Pharmacokinetics and biomarkers were also assessed. Results: A total of 51 patients reported ≥1 adverse event(s) (AEs) that were at least possibly related to either study drug. Grade 3–4 AEs, including anemia (26%), neutropenia (22%), lymphopenia (19%), fatigue (15%), and hypertension (11%), were Correspondence to: Robert Wesolowski recorded in 38 patients (70%). -
A Phase I Dose Escalation Study of Tivantinib (ARQ 197) in Adult
Author Manuscript Published OnlineFirst on October 5, 2011; DOI: 10.1158/1078-0432.CCR-11-1002 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. A Phase I Dose Escalation Study of Tivantinib (ARQ 197) in Adult Patients with Metastatic Solid Tumors Lee S. Rosen,1* Neil Senzer,2 Tarek Mekhail,3 Ram Ganapathi,3 Feng Chai,4 Ronald E Savage,4 Carol Waghorne,4 Giovanni Abbadessa,4 Brian Schwartz,4 Robert Dreicer3 1Premiere Oncology, 2020 Santa Monica Boulevard, Suite 600, Santa Monica, CA 90404. 2Mary Crowley Cancer Research Centers, 1700 Pacific St, Suite 1100, Dallas, TX 75201. 3 Department of Solid Tumor Oncology, Taussig Cancer Institute, Cleveland Clinic, 9500 Euclid Avenue R35, Cleveland, OH 44195. Dr. Mekhail is now with Florida Hospital Cancer Institute, 2501 North Orange Avenue, Orlando FL 32804. 4ArQule, Inc., Woburn, MA. *Corresponding author: Lee Rosen Tel: (310) 633-8400 Fax: (310) 633-8419 E-mail: [email protected] Running Title: Phase I Trial of Tivantinib in Patients with Metastatic Solid Tumors Key words: tivantinib, ARQ 197, pharmacokinetics, phase I, safety Word count: 3657 (not including Abstract and references) 41 references 5 tables and 1 figure 1 Downloaded from clincancerres.aacrjournals.org on September 23, 2021. © 2011 American Association for Cancer Research. Author Manuscript Published OnlineFirst on October 5, 2011; DOI: 10.1158/1078-0432.CCR-11-1002 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Translational Relevance Inhibitors of the receptor tyrosine kinase c-MET and its ligand, hepatocyte growth factor (HGF), have demonstrated activity in select cancer types. -
A Systematic Review and Meta-Analysis Comparing The
EUROPEAN UROLOGY 71 (2017) 426–436 available at www.sciencedirect.com journal homepage: www.europeanurology.com Review – Kidney Cancer A Systematic Review and Meta-analysis Comparing the Effectiveness and Adverse Effects of Different Systemic Treatments for Non-clear[3_TD$IF] Cell Renal Cell Carcinoma Sergio Ferna´ndez-Pello a,[3_TD$IF] Fabian Hofmann b, Rana Tahbaz c, Lorenzo Marconi d, Thomas B. Lam e,f, Laurence Albiges g, Karim Bensalah h, Steven E. Canfield i, Saeed Dabestani j, Rachel H. Giles k, Milan Hora l, Markus A. Kuczyk m, Axel S. Merseburger n, Thomas Powles o, Michael Staehler p, Alessandro Volpe q,Bo¨rje Ljungberg r, Axel Bex s,* a Department of Urology, Cabuen˜es Hospital, Gijo´n, Spain; b Department of Urology, Sunderby Hospital, Sunderby, Sweden; c Department of Urology, University Hospital Hamburg Eppendorf, Hamburg, Germany; d Department of Urology, Coimbra University Hospital, Coimbra, Portugal; e Academic Urology Unit, University of Aberdeen, Aberdeen, UK; f Department of Urology, Aberdeen Royal Infirmary, Aberdeen, UK; g Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France; h Department of Urology, University of Rennes, Rennes, France; i Division of Urology, University of Texas Medical School at Houston, Houston, TX, USA; j Department of Urology, Ska˚ne University Hospital, Malmo¨, Sweden; k Patient Advocate International Kidney Cancer Coalition (IKCC), University Medical Centre Utrecht, Department of Nephrology and Hypertension, Utrecht, The Netherlands; l Department of Urology, Faculty Hospital -
Crusader Q2 2020 Research Edition Download
Your resource for the latest research into the MET alteration. CRUSADER NEWSLETTER Q2 2020 RESEARCH EDITION MET Crusaders is a community of Lung Cancer patients and care givers collaborating with advocates and medical professionals collectively dedicated to helping patients with a MET alteration live normal lives. Come Join Us! [email protected] In this edition Top-level MET gene copy number gain defines .................... 2 Molecular Mechanisms of Acquired Resistance ................... 5 a subtype of poorly differentiated pulmonary to MET Tyrosine Kinase Inhibitors in Patients adenocarcinomas with poor prognosis with MET Exon 14-Mutant NSCLC EDITOR Characteristics and Clinical Outcomes of ............................. 2 MET Alterations Are a Recurring and Actionable .................. 6 Jessica McKernan, PharmD Non-Small Cell Lung Cancer Patients in Korea Resistance Mechanism in ALK-Positive Lung Cancer with MET Exon 14 Skipping Atrium Health Tepotinib in Non-Small-Cell Lung Cancer with ...................... 6 Charlotte, NC Clinical and molecular correlates of PD-L1 ........................... 2 MET Exon 14 Skipping Mutations (VISION Trial) expression in patients with lung adenocarcinomas Therapeutic Efficacy of ABN401, a Highly ............................. 7 CONTRIBUTING EDITORS Efficacy and Safety of Anti-PD-1 Immunotherapy ................. 3 Potent and Selective MET Inhibitor, Based on Julia Stevens, PharmD in Patients With Advanced NSCLC With BRAF, HER2, Diagnostic Biomarker Test in MET-Addicted Cancer or MET Mutations or RET Translocation: GFPC 01-2018 Beth Israel Deaconess Erlotinib plus tivantinib versus erlotinib alone ..................... 7 Medical Center Alterations in the PI3K Pathway Drive Resistance ................ 3 in patients with previously treated stage IIIb/IV Boston, MA to MET Inhibitors in NSCLC Harboring MET non-small-cell lung cancer: A meta-analysis based Exon 14 Skipping Mutations on randomized controlled trials Laura Schmidt, PharmD Incidence and PD-L1 Expression of MET 14 .........................