Business Wire

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Low Metastatic Breast Cancer with HR Positive and HR Negative Disease

Share

Daiichi Sankyo (TSE: 4568) today announced that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Patients with hormone receptor (HR) positive breast cancer must additionally have received or be ineligible for endocrine therapy.

Trastuzumab deruxtecan is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized 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-Breast04 phase 3 trial recently presented at the plenary session of the American Society of Clinical Oncology (#ASCO22) Annual Meeting and simultaneously published in The New England Journal of Medicine.

“Trastuzumab deruxtecan is the first HER2 directed therapy to demonstrate a survival benefit in patients with HER2 low metastatic breast cancer. We now have the potential to redefine how we classify and treat approximately half of all metastatic breast cancers,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Clinical Development, Oncology R&D, Daiichi Sankyo. “In addition to the ongoing review of two other applications for the treatment of patients with HER2 positive metastatic breast cancer or gastric cancer in Europe, we are pleased to have received this third validation for HER2 low metastatic breast cancer with the goal of bringing trastuzumab deruxtecan to as many eligible patients with HER2 targetable cancers as possible.”

In DESTINY-Breast04, trastuzumab deruxtecan demonstrated superior and clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2 low unresectable and/or metastatic breast cancer with HR positive or HR negative disease versus standard of care physician’s choice of chemotherapy. The safety profile of trastuzumab deruxtecan was consistent with previous clinical trials with no new safety concerns identified. Interstitial lung disease (ILD) or pneumonitis rates were consistent with that observed in late-line HER2 positive breast cancer trials of trastuzumab deruxtecan with a lower rate of grade 5 ILD observed, as determined by an independent adjudication committee.

About DESTINY-Breast04

DESTINY-Breast04 is a global, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of trastuzumab deruxtecan (5.4 mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR positive or HR negative, unresectable and/or metastatic breast cancer with low HER2 expression previously treated with one or two prior lines of chemotherapy. Patients were randomized 2:1 to receive either trastuzumab deruxtecan or chemotherapy.

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR positive disease based on blinded independent central review (BICR). Key secondary endpoints include PFS based on BICR in all randomized patients (HR positive and HR negative disease), OS in patients with HR positive disease and OS in all randomized patients (HR positive and HR negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety. DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About Breast Cancer and HER2 Expression

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, and is one of many biomarkers expressed in breast cancer tumors.3

HER2 expression is currently defined as either positive or negative, and is determined by an IHC test which estimates the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.3,4 HER2 positive cancers are defined as IHC 3+, IHC 2+/ISH+.3 HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3 Approximately half of all patients with breast cancer have tumors with a HER2 IHC score of 1+, or a HER2 IHC score of 2+ in combination with a negative ISH test, an expression level not currently eligible for HER2 targeted therapy.5,6,7,8 Low HER2 expression occurs in both HR positive and HR negative disease.9

HER2 testing is routinely used to determine appropriate treatment options for patients with metastatic breast cancer. Targeting the lower range of expression in the HER2 spectrum may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer.10 Currently, patients with low HER2 expression with HR positive tumors have limited treatment options following progression on endocrine (hormone) therapy.11 Few targeted options are available for those who are HR negative.12

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 Canada, Israel and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy, based on results from the DESTINY-Breast03 trial. Trastuzumab deruxtecan also is approved in approximately 40 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 theDESTINY-Breast01trial.

Trastuzumab deruxtecan (6.4 mg/kg) is 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.

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, also are underway.

Regulatory applications for trastuzumab deruxtecan are currently under review in China, Europe, Japan and several other countries for the treatment of adult patients with HER2 positive unresectable or metastatic breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.

Trastuzumab deruxtecan also is currently under review in the U.S. for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy based on the results from the DESTINY-Lung01 trial, and in Europe 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 based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

Trastuzumab deruxtecan was granted Breakthrough Therapy Designation in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results of the DESTINY-Breast04 trial. Patients with HR positive breast cancer should additionally have received or be ineligible for endocrine therapy.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo Company, Limited (referred to as 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

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
1Sung H, et al. CA Cancer J Clin. 2021;10.3322/caac.21660.
2Globocan 2020. Breast Cancer. Accessed: May 2022.
3Iqbal N, et al. Mol Biol Int. 2014;852748.
4Wolff A, et al. Arch Pathol Lab Med. 2018;142(11):1364-1382.
5Schalper K, et al. Arch Pathol Lab Med. 2014;138:213-219.
6Ahn S, et al. J Pathol Transl Med. 2020;54(1):34-44.
7Schettini F, et al. NPJ Breast Cancer. 2021;7:1.
8Denkert C, et al. Lancet Oncol. 2021;22:1151-61.
9Miglietta F, et al. NPJ Breast Cancer. 2021;7:137.
10Eiger D, et al. Cancers. 2021;10.3390/cancers13051015.
11Matutino A, et al. Current Oncology. 2018;25(S1):S131-S141.
12American Cancer Society. Breast Cancer Hormone Receptor Status.Accessed May 2022.

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:
Simone Jendsch-Dowé
Daiichi Sankyo Europe GmbH
simone.dowe@daiichi-sankyo.eu
+49 (89) 78080 (office)

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

Teva Announces Promising Interim Results From Its Study PEARL, About the Impact of AJOVY ® (fremanezumab)24.6.2022 18:54:00 CEST | Press release

Teva Pharmaceuticals Europe B.V. today announces promising interim results from its Pan-European Real World study (PEARL), presented for the first time at the European Academy of Neurology (EAN) Congress in Vienna, Austria. The two-year Pan-European Real World (PEARL) prospective, observational study of AJOVY® (fremanezumab), looks at its effectiveness in patients with chronic migraine or episodic migraine, and is an ongoing study sponsored by Teva Pharmaceuticals Europe BV.1 These findings further offer insight into the treatment of migraine in real-world clinical practice. The interim findings were presented by Faisal Mohammad Amin, Associate Professor of Neurology at the University of Copenhagen, Denmark. Out of the total planned 1100 patients in PEARL, 389 patients are included in the interim analysis presented. These findings show that 54.7% of patients in the study had their monthly-migraine-days reduced by 50% or more, over the six-month period from the start of treatment. Addit

Brigade-M3 European Acquisition Corp. 2021 Annual Report24.6.2022 16:59:00 CEST | Press release

Brigade-M3 European Acquisition Corp. (the “Company”), a special purpose acquisition company that was incorporated on 21 April 2021 under the laws of the Cayman Islands as an exempted company with limited liability and is listed on Euronext Amsterdam, today published its annual report for the period 21 April 2021 to 31 December 2021. The full report can be downloaded from the Company’s website via the following link: https://www.brigadem3eac.com/documents IMPORTANT INFORMATION This press release contains information that qualifies as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. DISCLAIMER This announcement is not for distribution or release, directly or indirectly, and should not be distributed in or sent into, the United States, Australia, Canada, Japan, the Cayman Islands or South Africa or any other jurisdiction in which such distribution or release would be unlawful or would require registration or other measures. This announcement does n

PUMA Kicks Off Its Largest Web3 Collaboration To Date, with 10KTF Shop24.6.2022 16:41:00 CEST | Press release

PUMA has entered New Tokyo, the virtual city 10KTF calls home. The shop is known for its streetwear offerings and is owned by Wagmi-san, a digital artisan whose collections and NFT community recently welcomed the global sports brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220624005314/en/ PUMA Kicks Off Its Largest Web3 Collaboration To Date, with 10KTF Shop PUMA has entered New Tokyo, the virtual city 10KTF calls home. The shop is known for its streetwear offerings and is owned by Wagmi-san, a digital artisan whose collections and NFT community recently welcomed the global sports brand. (Photo: Business Wire) News of the partnership was shared at an event hosted by 10KTF last night in New York. Their event was one of many hosted during the week of NFT.NYC, a conference attended by crypto industry professionals, traders, and other web3 enthusiasts. The official announcement confirms weeks of speculation after PUMA tw

Suzano outlines ESG milestone achievements and commitments at second annual ESG call24.6.2022 16:14:00 CEST | Press release

Suzano, the world’s largest hardwood pulp producer, today held its second annual ESG Call centered around its ambition to be a ‘regenerative company for a regenerative society’. Today’s ESG Call spotlighted measurable progress and ambitions across three core areas of action: climate change, biodiversity and social development. On Climate Change, the ACT initiative of the French Government and CDP scored Suzano ahead of its pulp and paper industry peers in virtually every metric. In 2021, Suzano brought forward its target for removing 40 million tons of carbon dioxide from the atmosphere from 2030 to 2025 which is being achieved through improvements to its industrial processes, such as systematically replacing the use of fossil fuels at its industrial plants with biomass, and through conversion of degraded land. As part of the company’s social commitments, Suzano launched a target in 2020 to lift 200,000 people out of poverty. This is more than pertinent, given that in Brazil, 10% of th

Kyowa Kirin Receives Positive CHMP Opinion for Use of CRYSVITA ® ▼ (burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)24.6.2022 15:38:00 CEST | Press release

Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that CRYSVITA® (burosumab) be approved for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.1 CRYSVITA is also already licensed for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.2 Also known as oncogenic osteomalacia, TIO is an acquired disorder caused by typically small, slow-growing, benign PMTs.3,4 It is a rare condition with less than 1000 cases reported in the medical literature,4 which mainly affects adults and with a mean onset age of 40 – 45 years.3,5 TIO is associated with p

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