Business Wire

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Share

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.

Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). This application is based on data from the DESTINY-Breast03 phase 3 trial presented at the 2021 European Society for Medical Oncology (ESMO) Congress.

Breast cancer is the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 In Europe, approximately 531,000 cases of breast cancer are diagnosed annually.2 Approximately one in five cases of breast cancer are considered HER2 positive.3 Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression.4 More treatment options are needed to further delay progression and extend survival.4,5,6

“We are excited to have submitted a second application this year seeking approval for trastuzumab deruxtecan for a potential third indication in Europe,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “With this specific application, we look forward to working closely with the EMA to support the review of trastuzumab deruxtecan to be used in an earlier setting for patients with HER2 positive metastatic breast cancer.”

In DESTINY-Breast03, trastuzumab deruxtecan demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1) (hazard ratio [HR] = 0.28; 95% confidence interval [CI]: 0.22-0.37; p=7.8x10-22) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The median progression-free survival (PFS) for patients treated with trastuzumab deruxtecan was not reached (95% CI: 18.5-NE) compared to 6.8 months for T-DM1 (95% CI: 5.6-8.2) as assessed by blinded independent central review (BICR). In the secondary endpoint analysis of PFS assessed by investigators, patients treated with trastuzumab deruxtecan experienced an improvement in PFS of 25.1 months (95% CI: 22.1-NE) compared to 7.2 months (95% CI: 6.8-8.3) for T-DM1 (HR=0.26; 95% CI: 0.20-0.35). There was a strong trend towards improved overall survival (OS) with trastuzumab deruxtecan (HR=0.56; 95% CI: 0.36-0.86; p=0.007172), however this analysis is not yet mature and is not statistically significant. Nearly all patients treated with trastuzumab deruxtecan were alive at one year (94.1%; 95% CI: 90.3-96.4) compared to 85.9% of patients treated with T-DM1 (95% CI: 80.9-89.7). Confirmed objective response rate (ORR) was more than doubled in the trastuzumab deruxtecan arm versus the T-DM1 arm (79.7% [n=208; 95% CI: 74.3-84.4] versus 34.2% [n=90; 95% CI: 28.5-40.3]).

The safety profile of the most common adverse events with trastuzumab deruxtecan in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified. The most common grade 3 or higher drug-related treatment emergent adverse events in the trastuzumab deruxtecan arm were neutropenia (19.1%), thrombocytopenia (7.0%), leukopenia (6.6%), nausea (6.6%), anemia (5.8%), fatigue (5.1%), vomiting (1.6%), increase in ALT (1.6%), decreased appetite (1.2%), increase in AST (0.8%), diarrhea (0.4%) and alopecia (0.4%). Overall, 10.5% of patients had interstitial lung disease (ILD) or pneumonitis related to treatment as determined by an independent adjudication committee. The majority of ILD events (9.7%) were low grade (grade 1 (2.7%) or grade 2 (7.0%)) with two grade 3 (0.8%) events reported. No grade 4 or grade 5 ILD or pneumonitis events occurred.

About HER2 Positive Breast Cancer

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.1 More than two million cases of breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 In Europe, approximately 531,000 cases of breast cancer are diagnosed annually.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers.7 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.8 Approximately one in five cases of breast cancer are considered HER2 positive.3

Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression.4 More treatment options are needed to further delay progression and extend survival.4,5,6

About DESTINY-Breast03

DESTINY-Breast03 is a global, head-to-head, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of trastuzumab deruxtecan (5.4 mg/kg) versus T-DM1 in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The primary efficacy endpoint of DESTINY-Breast03 is PFS based on BICR. Secondary efficacy endpoints include OS, ORR, duration of response, PFS based on investigator assessment and safety. DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About Trastuzumab Deruxtecan

Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Trastuzumab deruxtecan consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Trastuzumab deruxtecan (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

A supplemental New Drug Application is under review in Japan for the treatment of adult patients with HER2 positive unresectable or recurrent breast cancer previously treated with trastuzumab and a taxane, based on the results from the DESTINY-Breast03 trial.

Trastuzumab deruxtecan (6.4 mg/kg) is also approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

A Type II Variation is currently under review by the EMA for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen.

About the Trastuzumab Deruxtecan Clinical Development Program

A comprehensive global development program is underway evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Trastuzumab deruxtecan was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the “ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers,” based on data from both the DESTINY-Gastric01 and DESTINY-CRC01 trials, as well as one of the targeted therapy advances of the year in NSCLC based on the interim results of the HER2 mutant cohort of the DESTINY-Lung01 trial.

Trastuzumab deruxtecan recently received its fourth Breakthrough Therapy Designation in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

About Daiichi Sankyo in Oncology

The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit: www.daiichisankyo.com.

References:

______________________
1 Sung H, et al. CA Cancer J Clin. 2021; 10.3322/caac.21660.
2 Globocan 2020. Breast Cancer. Last accessed: October 2021.
3 Ahn S, et al. J Pathol Transl Med. 2020; 54(1): 34-44.
4 Barok M, et al. Breast Cancer Res. 2014; 16(2):209.
5 Mounsey L, et al. Clin Breast Cancer. 2018;18(1):29-37.
6 Martínez-Sáez O, Prat A.JCO Oncol Pract. 2021. 10.1200/OP.21.00172
7 Iqbal N, et al. Mol Biol Int. 2014;852748.
8 Pillai R, et al. Cancer. 2017;1;123(21):4099-4105.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media:

Global:
Victoria Amari
Daiichi Sankyo, Inc.
vamari@dsi.com
+1 908 900 3010 (mobile)

EU:
Lydia Worms
Daiichi Sankyo Europe GmbH
lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)
+49 176 11780861 (mobile)

Japan:
Masashi Kawase
Daiichi Sankyo Co., Ltd.
kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations:
DaiichiSankyoIR@daiichisankyo.co.jp

About Business Wire

Business Wire
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

Enedym Inc. Announces Strategic Partnership With JFE Shoji25.1.2022 14:00:00 CET | Press release

Enedym Inc. (“Enedym”), the technology company thatdevelops next generation switched reluctance motors (SRMs), electric propulsion, and electrified powertrains, announced today that it has formed a strategic partnership with JFE Shoji Power Canada Inc., (“JFE Shoji Canada”), one of the largest providers of transformer cores, magnetic materials for electrical engineering applications, and electrical engineering support and design services in North America. Under the terms of the partnership, JFE Shoji Canada, will be a key supplier of electrical steel for Enedym’s electric motors and powertrains. JFE Shoji Canada is part of the JFE Shoji Corporation (“JFE Shoji Corp”), a global supplier of electrical steel materials and products to the global auto industry and leading electric vehicle automakers like Rivian Automotive, Inc. through its world-wide motor core manufacturing and supply business in Mexico, India, China, Japan and Asia, with supportive ownership from JFE Holdings of Japan. Dr

B2Broker Group Acquires Mauritius FSC Licence to Provide Multi-Asset Brokerage Services25.1.2022 13:00:00 CET | Press release

B2Broker, a leading liquidity and technology provider of solutions to the Forex and financial services industry, has secured a licence from the Financial Services Commission (FSC) Mauritius, the company has announced. The licence has been acquired under the name of B2B Prime Services Limited, a member of the B2Broker Group of Companies, which as of 12th November, 2021, possesses an Investment Dealer licence (Full Service Dealer excluding underwriting /code SEC-2.1, Licence # C117017139). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220125005241/en/ Under Mauritius regulation, the company will operate as a Prime of Prime (PoP) Multi-Asset Liquidity Provider, focusing on institutional and professional clients across the whole spectrum of the financial markets. Its core investment services consist of leveraged derivative products in CFDs (e.g. Forex, metals, commodities, shares, indices). (Graphic: Business Wire) Description

BitMEX Welcomes New Head of Trading Bill Beller25.1.2022 12:03:00 CET | Press release

Crypto investment platform BitMEX is delighted to welcome Bill Beller as Head of Trading, effective 1 January. Bill is in charge of spearheading the company’s trading strategies and expanding the BitMEX trading team and its capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220125005650/en/ BitMEX Welcomes New Head of Trading Bill Beller (Photo: Business Wire) Prior to joining BitMEX, Bill was Managing Director at Greenville Advisory for nearly five years, where he helped FinTech start-ups launch crypto exchange platforms and meet evolving regulatory requirements. Prior to that, he was Managing Director - Head of Equities for Sberbank CIB and Managing Director, Head of EEMEA Equity Derivatives Flow Trading at UniCredit. He brings over a decade of experience in risk management, building trading infrastructure, and managing equities and derivatives investments across global capital markets. Bill said: “BitMEX is fast

Lithion Recycling Enters a Partnership with IS Dongseo Company for an Exclusive License of its Lithium-ion Battery Recycling Technology in South Korea25.1.2022 12:00:00 CET | Press release

Lithion Recycling, Inc. (“Lithion”) is proud to announce it has reached an agreement with IS Dongseo Company Ltd (“ISD”), a Korea-based leading ESG company with an environmental business segment, for an exclusive business right for the use of its lithium-ion battery recycling technology on the Korean market. This partnership is the first of a series that Lithion aims to conclude in upcoming years for the use of its cutting-edge, eco-friendly technology on world markets. It will allow ISD to offer an environmentally friendly and cost-effective recycling solution to close the loop on battery materials in Korea. IS Dongseo plans to start building its first Korean facility capable of processing about 7,500 tons of waste batteries per year (or the equivalent of approximately 20,000 electric car batteries), this year. This first phase will be followed by a second one, with the construction of a hydrometallurgy plant based on Lithion’s technology, allowing ISD to supply over 15,000 tons of ba

Square Announces Official Launch in Spain After Successful Early Access Programme25.1.2022 11:30:00 CET | Press release

Square, the company specialising in software, payments, and hardware solutions for businesses of all sizes, announces its arrival in Spain following a successful Early Access Programme. Starting today, Spanish entrepreneurs, freelancers and business owners will be able to use Square's ecosystem of tools; the only end-to-end solution of its kind in the country. "We’ve been trialing Square’s suite of products both in-store and online and we love it,” said Miguel Gil, owner of Hop Hop Hurrah, one of the first businesses to use Square’s products in Spain. “Having a point-of-sale system with integrated payments and omnichannel solutions has transformed the way we’re able to run our business, making it an easy and seamless process. We’re pleased we were able to switch to Square and feel much more confident in our ability to grow, ensuring we never miss a sale, as we look towards the future.” Square is part of Block, Inc. a global technology company focused on financial services, founded in 2

J.P. Morgan to Acquire a Stake in Viva Wallet25.1.2022 11:00:00 CET | Press release

J.P. Morgan (NYSE: JPM) announced today that it has entered into an agreement with Viva Wallet Holdings Software Development S.A. (Viva Wallet), a leading European cloud-based payments fintech company, and its existing shareholders to acquire an ownership stake of approximately 49 percent, subject to regulatory approvals. Financial terms of the transaction were not disclosed. “We are very excited to make a strategic investment in Viva Wallet to support their vision to empower new growth and payments innovation targeted at European small and midsize businesses (SMBs) and middle market merchant services clients,” said Takis Georgakopoulos, Global Head of J.P. Morgan Payments. “The European payments landscape is fragmented yet large in terms of opportunity, with more than 17 million merchants1 ready to implement scalable payments solutions and this is a big focus area for added growth for J.P. Morgan Payments in the future.” Founded in 2000, Viva Wallet is headquartered in Athens, Greece,

The O-RAN ALLIANCE Announces the 5 th Release of Its Open Source Software and An Industry Briefing at MWC Barcelona25.1.2022 10:49:00 CET | Press release

O-RAN ALLIANCE: O-RAN ALLIANCE Industry Briefing, March 1, 2022 at MWC Barcelona O-RAN ALLIANCE plans to hold its next industry event on March 1, 2022 from 17:15-18:00 CET, hosted at the Deutsche Telekom booth at MWC Barcelona 2022, Hall 3 Stand 3M31. The event will include keynotes from O-RAN ALLIANCE’s leadership and an industry panel discussion. Save the date and follow our website for further updates. 5th Release of Open Software for the RAN – “E” – Delivered by the O-RAN Software Community The O-RAN Software Community (OSC or O-RAN SC) was formed in partnership with the Linux Foundation in April 2019, to support software development of open RAN solutions available to everyone. In December 2021, following on the half year release cycle, the OSC published its 5th open software release dubbed "E". The E release further enhances the traffic steering use case, introduces basic RAN slicing feature and closed loop slice SLA assurance. With these enhanced features and the end-to-end integ

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