Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo Company, Limited(hereafter, Daiichi Sankyo) and AstraZeneca’s trastuzumab deruxtecan has been recommended for conditional marketing authorization in the European Union (EU) as monotherapy 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.

In Europe, approximately 520,000 cases of breast cancer in women are diagnosed annually, with roughly one in five cases being HER2 positive.^1,2 The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year.¹

Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on results from the pivotal phase 2 DESTINY-Breast01 trial, which were published in TheNew England Journal of Medicine, and the results from the phase 1 trial published in TheLancet Oncology. In the DESTINY-Breast01 trial, trastuzumab deruxtecan demonstrated clinically meaningful and durable activity in patients who had received two or more prior anti-HER2 therapies. The safety and tolerability profile of trastuzumab deruxtecan seen in DESTINY-Breast01 was consistent with that observed in the phase 1 trial.

An updated analysis from DESTINY-Breast01, reinforcing the durable efficacy and long-term safety and tolerability profile of trastuzumab deruxtecan, was presented earlier this week at the 2020 San Antonio Breast Cancer Symposium (SABCS).

“We are encouraged by the CHMP positive opinion given the significant unmet need for patients with HER2 positive metastatic breast cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “Trastuzumab deruxtecan is already available for patients with HER2 positive metastatic breast cancer in the U.S. and Japan, and we are now one step closer to bringing this important new medicine to patients in Europe.”

“The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting,” said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2 positive metastatic breast cancer.”

The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

About HER2 Positive Breast Cancer

Approximately 520,000 cases of breast cancer are diagnosed in Europe annually, with an estimated one in five cases being HER2 positive.^1,2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast, gastric and lung cancers. HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poor prognosis in breast cancer.³

There remain significant unmet clinical needs for patients with HER2 positive metastatic breast cancer. The disease remains incurable with patients eventually progressing after currently available treatment options.^4,5

About DESTINY-Breast01

DESTINY-Breast01 is a pivotal phase 2, single-arm, open-label, global, multicenter, two-part trial evaluating the safety and efficacy of trastuzumab deruxtecan in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with 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.

About Trastuzumab Deruxtecan

Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (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.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Trastuzumab deruxtecan is comprised of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker.

Trastuzumab deruxtecan (5.4 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2 based regimens based on the DESTINY-Breast01 trial.

Trastuzumab deruxtecan (6.4 mg/kg) is also approved in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy, based on the DESTINY-Gastric01 trial.

About the Trastuzumab Deruxtecan Clinical Development Program

A comprehensive development program is underway globally, with nine pivotal trials evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 targetable cancers, including breast, gastric, colorectal and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

In October 2020, trastuzumab deruxtecan was granted Priority Review from the U.S. Food and Drug Administration (FDA) for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. In May 2020, trastuzumab deruxtecan received a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation for gastric cancer, including GEJ adenocarcinoma.

In July 2020, the EMA’s CHMP granted trastuzumab deruxtecan accelerated assessment for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.

In May 2020, trastuzumab deruxtecan had also received a Breakthrough Therapy Designation (BTD) for the treatment of patients with metastatic non-small cell lung cancer whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.

About the Collaboration Between Daiichi Sankyo and AstraZeneca

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan (a HER2 directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

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 our DXd antibody drug conjugate (ADC) technology, our powerful 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 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.

References:

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¹ GLOBOCAN 2018. Breast Cancer Fact Sheet. World Health Organization. Accessed: December 2020.
² DeKoven et al. J Comp Eff Res. 2012 Sep;1(5):453-63
³ Iqbal N, et al. Mol Biol Int. 2014;852748.
⁴ de Melo Gagliato D, et al. Oncotarget. 2016;7(39):64431-46.
⁵ The National Comprehensive Cancer Network (NCCN). NCCN Guidelines Version 3. 2020. Breast Cancer. March 2020.

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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)

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

Investor Relations:
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