Positive Pivotal Data for Daiichi Sankyo’s DS-8201 ([Fam]-Trastuzumab Deruxtecan) in Patients with HER2 Positive Metastatic Breast Cancer to be Presented at SABCS
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191119005106/en/
Contact information
Media Contacts:
Global/US:
Jennifer Brennan
Daiichi Sankyo, Inc.
jbrennan2@dsi.com
+1 908 992 6631 (office)
+1 201 709 9309 (mobile)
Japan:
Koji Ogiwara
Daiichi Sankyo, Co., Ltd
ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
About Business Wire
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
“e4life” is Present at Expomed Eurasia with its Innovative Device Able to Inactivate Flu and Covid Viruses With an Efficacy over 90%19.4.2024 17:13:00 CEST | Press release
Expomed Eurasia, the most important medical exhibition between Europe and Asia, is ready to house more than a hundred companies, to discover new technological trends and the most innovative products which are going to change deeply the health market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240419226980/en/ e4life: e4ambient and e4you devices (Photo: Business Wire) This is a perfect occasion for e4life to present its device based on the e4shield technology which is able to inactivate flu and Covid viruses present in the air. A technology, patented in Italy, that uses neither chemical agents nor filtering materials, but it is based on the transmission of electromagnetic waves able to inactivate the viral load in aerosol. “This Exhibition represents an extraordinary opportunity to present our innovative technology (e4shield) in a dynamic and rapidly evolving region as Eurasia. In a climate of growing consciousness of the
Qualcomm Schedules Second Quarter Fiscal 2024 Earnings Release and Conference Call19.4.2024 15:00:00 CEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced that it will publish the Company’s financial results for its second quarter fiscal 2024 on Wednesday, May 1, 2024, after the close of the market on the Company’s Investor Relations website, at https://investor.qualcomm.com/financial-information. The earnings release will also be furnished to the Securities and Exchange Commission (SEC) on a Form 8-K, which will be available on the SEC website at http://www.sec.gov. Qualcomm will host a conference call to discuss its second quarter fiscal 2024 results which will be broadcast live on May 1, 2024, beginning at 1:45 p.m. Pacific Time (PT) at https://investor.qualcomm.com/news-events/events. An audio replay will be available at https://investor.qualcomm.com/news-events/events and via telephone following the live call for 30 days thereafter. To listen to the replay via telephone, U.S. callers may dial (877) 660-6853 and international callers may dial (201) 612-7415. Callers should use rese
Newmont Appoints Mining Industry Veteran Francois Hardy as Chief Technology Officer19.4.2024 14:56:00 CEST | Press release
Newmont Corporation (NYSE: NEM, TSX: NGT, ASX: NEM, PNGX: NEM) today announced the appointment of Francois Hardy as Chief Technology Officer (CTO). Francois will join Newmont’s Executive Leadership Team and lead the technical work across the business to improve operational performance and drive growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240419973025/en/ Newmont Appoints Mining Industry Veteran Francois Hardy as Chief Technology Officer (Photo: Business Wire) Francois will take over from interim CTO, Dean Gehring, who also served in a dual role as Newmont’s Chief Integration Officer. After a period of transition, Dean will be leaving the company in early July. Francois brings more than 30 years of technical and operational experience in mining to the role. He commenced with Newmont in 2002 and has held roles including Group Head Exploration, Managing Director Africa and General Manager Tanami. “Francois is a stron
SLB Announces First-Quarter 2024 Results, Targeting to Return $7 Billion to Shareholders Over 2024–202519.4.2024 12:50:00 CEST | Press release
SLB (NYSE: SLB) today announced results for the first-quarter 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240417469361/en/ The exterior of the SLB headquarters in Houston, Texas (Photo: Business Wire) First-Quarter Results (Stated in millions, except per share amounts)Three Months EndedChangeMar. 31, 2024Dec. 31, 2023Mar. 31, 2023 SequentialYear-on-yearRevenue $8,707 $8,990 $7,736 -3% 13% Income before taxes - GAAP basis $1,357 $1,433 $1,161 -5% 17% Income before taxes margin - GAAP basis 15.6% 15.9% 15.0% -35 bps 58 bps Net income attributable to SLB - GAAP basis $1,068 $1,113 $934 -4% 14% Diluted EPS - GAAP basis $0.74 $0.77 $0.65 -4% 14% Adjusted EBITDA* $2,057 $2,277 $1,788 -10% 15% Adjusted EBITDA margin* 23.6% 25.3% 23.1% -171 bps 51 bps Pretax segment operating income* $1,649 $1,868 $1,391 -12% 19% Pretax segment operating margin* 18.9% 20.8% 18.0% -184 bps 95 bps Net income attributable to SLB, excluding cha
Zayo Group Appoints New CEO of Zayo Europe19.4.2024 09:00:00 CEST | Press release
Zayo Group, a leading global provider of network infrastructure, has appointed Colman Deegan as its new CEO of Zayo Europe to drive the business’ growth as cloud and AI adoption continues across the continent. This appointment is effective as of April 16, 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240419471253/en/ Colman Deegan, CEO Zayo Europe (Photo: Business Wire) Steve Smith, CEO Zayo Group, says, “Colman’s experience and proven track record as a CEO leading large teams and businesses makes him perfectly equipped to take our European business to new heights, together with our outstanding local team. Colman will drive Zayo forward, strengthening our partnerships with data centres, hyperscalers, and enterprises across Europe. Under Colman’s leadership, we are confident that we will achieve our bold ambitions and maximise our impact in the European market.” Deegan spent more than two decades at Vodafone where he h