NJ-DAIICHI-SANKYO
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it will present new data across its investigational ADC portfolio at the 2019 San Antonio Breast Cancer Symposium (#SABCS19), December 10-14, 2019 in San Antonio, Texas.
Positive data from the pivotal phase 2 DESTINY-Breast01 trial of DS-8201 ([fam-] trastuzumab deruxtecan), an investigational HER2 targeting antibody drug conjugate (ADC), will be unveiled, highlighting objective response rate, progression-free survival, duration of response and safety seen in patients with HER2 positive metastatic breast cancer previously treated with ado-trastuzumab emtansine.
Trial-in-progress updates from the pivotal phase 3 development program of DS-8201 in patients with HER2 positive metastatic breast cancer, including a head-to-head study with ado-trastuzumab emtansine, and in patients with HER2 low metastatic breast cancer, also will be presented. An overview of the phase 1/2 trial for U3-1402, an investigational HER3 targeting ADC, in HER3 expressing advanced/unresectable or metastatic breast cancer also will be featured at SABCS.
“Following the recent Priority Review acceptance of our BLA by the FDA and our regulatory submission in Japan, we look forward to presenting the pivotal results of DS-8201 monotherapy in patients with HER2 positive metastatic breast cancer at SABCS,” said Antoine Yver, MD, MSc, EVP and Global Head, Oncology Research and Development, Daiichi Sankyo. “These data, coupled with other important scientific discussions surrounding our other pivotal studies in HER2 positive and HER2 low metastatic breast cancer, underscore the commitment we have in bringing DS-8201 to as many patients as possible.”
The ADC portfolio of Daiichi Sankyo currently consists of seven novel ADCs, with four in clinical development across multiple types of cancer, including DS-8201, which is being co-developed and co-commercialized globally with AstraZeneca; U3-1402 (targeting HER3); DS-1062 (targeting TROP2) and DS-7300 (targeting B7-H3). Each ADC is engineered and designed using Daiichi Sankyo’s proprietary DXd ADC technology, which consists of a monoclonal antibody attached by a tetrapeptide-based linker to a novel topoisomerase I inhibitor payload. Each ADC is constructed to target and deliver chemotherapy inside cancer cells that express a specific cell surface antigen, and each has a customized drug to antibody ratio (DAR) designed to optimize the risk-benefit ratio for the intended patient population.
Following SABCS, Daiichi Sankyo will hold its first-ever U.S.-based R&D Day for investors and analysts on Thursday, December 19, 2019 at 10:30 AM ET at the New York Hilton Midtown in New York, NY. Company executives will provide an overview of the DS-8201 data presented at SABCS, unveil a new R&D strategy, including updated clinical development plans across the investigational ADC portfolio, and address questions from investors and analysts. Investors are invited to register for R&D Day by emailing DaiichiSankyoIR@daiichisankyo.co.jp prior to the event.
Following is an overview of data from Daiichi Sankyo to be presented at SABCS:
SABCS Abstract |
Presentation Details |
[Fam-] trastuzumab deruxtecan (T-DXd; DS-8201 in subjects with HER2-positive metastatic breast cancer (MBC) previously treated with T-DM1: A phase 2, multicenter, open-label study (DESTINY-Breast01) |
Session Title: General Session 1
|
A phase 1, multicenter, open-label study to assess the effect of [fam-] trastuzumab deruxtecan (T-DXd; DS-8201) on QTc and pharmacokinetics in subjects with HER2-expressing metastatic and/or unresectable breast cancer |
Program Number: P1-18-12
|
A phase 3, multicenter, randomized, open-label trial of [fam-] trastuzumab deruxtecan (T-DXd; DS-8201) vs. investigator’s choice in HER2-low breast cancer (DESTINY-Breast04) |
Program Number: OT1-07-02
|
[Fam-] trastuzumab deruxtecan (T-DXd; DS-8201) vs. ado-trastuzumab emtansine (T-DM1) in subjects with HER2-positive, unresectable and/or metastatic breast cancer who previously received trastuzumab and a taxane: a phase 3, randomized trial (DESTINY-Breast03) |
Program Number: OT1-07-01
|
[Fam-] trastuzumab deruxtecan (T-DXd; DS-8201) vs. investigator’s choice of treatment in subjects with HER2-positive, unresectable and/or metastatic breast cancer who previously received TDM-1: a randomized, phase 3 trial (DESTINY-Breast02) |
Program Number: OT1-07-04 Session Title: Antibody-Drug Conjugates Date/Time: Wednesday, December 11, 2019; 5:00-7:00 PM CT Location: Hall 1 |
Phase 1/2 first-in-human study of U3-1402, an anti-human epidermal growth factor receptor 3 (HER3) antibody-drug conjugate, in HER3-expressing advanced/unresectable or metastatic breast cancer, including those with triple negative breast cancer (TNBC) or HER3-low disease |
Program Number: OT1-07-06
|
Evaluation of patritumab/paclitaxel/trastuzumab over standard paclitaxel/trastuzumab in early stage, high-risk HER2 positive breast cancer: Results from the neoadjuvant I-SPY 2 TRIAL |
Program Number: P3-11-02
|
About DESTINY-Breast01
DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part trial evaluating the safety and efficacy of DS-8201 in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with ado-trastuzumab emtansine. The primary endpoint of the trial is objective response rate, as determined by independent central review. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival. Enrollment into DESTINY-Breast01 was completed in September 2018 with 253 patients at more than 100 sites across North America, Europe, Japan and other countries in Asia.
The safety and tolerability profile of DS-8201 in DESTINY-Breast01 was consistent with the phase 1 trial data published in The Lancet Oncology ,1 in which the most common adverse events (≥30 percent, any grade) included nausea, decreased appetite, vomiting, alopecia, fatigue, anemia, diarrhea and constipation. Cases of drug-related interstitial lung disease (ILD) and pneumonitis, including grade 5 events, have also been reported in the clinical development program.
About DS-8201
DS-8201 (fam-trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise and the most advanced program in AstraZeneca’s ADC scientific platform.
In March 2019, Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize DS-8201 as a potential new medicine worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for the manufacturing and supply.
A comprehensive development program for DS-8201 is underway globally with five pivotal trials in HER2 expressing metastatic breast and gastric cancer, including a trial in patients with metastatic breast cancer and low levels of HER2 expression (HER2 low). Phase 2 trials are underway for HER2 expressing advanced colorectal cancer as well as metastatic non-squamous HER2 overexpressing or HER2 mutated non-small cell lung cancer. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.
The U.S. Food and Drug Administration (FDA) recently granted Priority Review for the Biologics License Application (BLA) for DS-8201 for the treatment of HER2 positive metastatic breast cancer, which previously received Breakthrough Therapy and Fast Track Designations. A regulatory submission for DS-8201 also has been made to Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of HER2 positive metastatic breast cancer, and it has previously received SAKIGAKE designation for the treatment of advanced HER2 positive gastric or gastroesophageal junction cancer by Japan’s MHLW.
About U3-1402
U3-1402 is an investigational and potential first-in-class HER3 targeting ADC currently in phase 1/2 development for HER3 expressing metastatic or unresectable breast cancer in the U.S. and Japan and phase 1 development for metastatic or unresectable non-small cell lung cancer in the U.S.
DS-8201, U3-1402, DS-1062 and DS-7300 are investigational agents that have not been approved for any indication in any country. Safety and efficacy have not been established.
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science pipeline, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com .
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com .
Reference:
1 Tamura, K, et al. Trastuzuamb deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol . 2019;20(6):816-826.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191119005106/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Andersen Consulting tilføjer Stratence Partners30.5.2025 16:07:00 CEST | Pressemeddelelse
Andersen Consulting udvider sin platform med en samarbejdsaftale med Stratence Partners, der er et konsulentfirma med base i Storbritannien, som hjælper globale virksomheder med at øge markedsandele og forbedre rentabiliteten gennem deres ekspertise inden for prisfastsættelse, strategisk optimering, kommerciel effektivitet og digital transformation. Stratence Partners har en resultatorienteret tilgang og er forpligtet på bæredygtig forandring, hvorved de hjælper deres kunder gennem en unik kombination af konsulentbistand, midlertidige ledelsesindsater og oplæringskurser samt deres egne metoder og løsninger inden for datastyring, datavidenskab (AI), værktøjer og systemer. "Samarbejdet med Andersen Consulting er et spændende skridt for vores firma," sagde Fernando Ventureira, administrerende direktør for Stratence Partners. "I vores arbejde med hos ledere over hele verden har vi erfaret, at deres behov rækker ud over strategisk prisfastsættelse og driftsoptimering. Vores kunder værdsætte
You Up? Grindr’s “Right Now” Goes Global30.5.2025 15:00:00 CEST | Press release
More places, more people – Grindr’s real-time hookup feature makes connecting faster than ever Grindr, the Global Gayborhood in Your Pocket™ with more than 14.6M average monthly active users, today announced the global launch of Right Now, their newest intent-based feature designed to instantly connect people looking for immediate encounters. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250530651954/en/ Grindr's Right Now feature. Right Now is a real-time feed—separate from the app’s main grid that displays profiles—where Grindr users can post text and share photos displayed for one hour, letting other like-minded users know exactly what they’re looking for. “Right Now empowers our users to find exactly what they want, when they want it – without the guesswork,” said AJ Balance, Chief Product Officer at Grindr. “We built this intention-based feature based on feedback from our community so they can connect with like-minded
CAR T Vision Coalition Launches with Ambitious Goal to Double Patients Treated with the Curative Potential of CAR T-cell Therapy by 203030.5.2025 14:00:00 CEST | Press release
Only approximately 2 out of 10 people in the US and 3 out of 10 people in Europe with certain rare, advanced blood cancers receive access to CAR T-cell therapy1,2,3New roadmap report aims to inspire collective action of stakeholder groups and invites additional CAR T-cell therapy leaders to join the coalition Today an international coalition announces the launch of CAR T Vision to unite stakeholders around the shared ambition that every eligible patient should have the opportunity for cure with CAR T-cell therapy. By 2030, the aim is to double the proportion of eligible patients treated with CAR T-cell therapy. As outlined in the new roadmap report, the coalition will work to address access challenges and drive meaningful change in the CAR T-cell therapy healthcare ecosystem with a focus on three critical priorities: increasing awareness and understanding of CAR T-cell therapy; expanding resources and capacity to deliver CAR T-cell therapy; and developing sustainable and innovative fin
Indian Educationist Dr. Achyuta Samanta Recognised With Research Institute in His Name at CUNY, USA30.5.2025 11:17:00 CEST | Press release
In a noteworthy development underscoring growing academic collaboration between India and the United States, the City University of New York (CUNY) has launched a dedicated research platform—the Achyuta Samanta India Initiative of the CUNY CREST Institute (ASIICCI). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250529012005/en/ Dr. Milton Santiago, President of Bronx Community College, and Dr. Achyuta Samanta, Founder of KIIT & KISS, jointly inaugurate the Achyuta Samanta India Initiative of CUNY CREST Institute (ASIICCI) with a ribbon-cutting ceremony in New York. Named after Dr. Achyuta Samanta, a noted Indian educationist and social worker, the initiative focuses on academic research in Indian social and educational sectors, with a particular lens on Odisha. This marks one of the rare instances of a living Indian being honoured with such a naming in an American public university system. Dr. Samanta, who hails from Odisha
FDA Grants De Novo Clearance for Reflow Medical's Spur® Peripheral Retrievable Stent System30.5.2025 06:08:00 CEST | Press release
Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company’s Spur Peripheral Retrievable Stent System, a unique clinical solution for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250529610368/en/ The first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as Retrievable Scaffold Therapy (RST), the spikes on the Spur Stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel complia
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom