DATROWAY® Approved in the EU for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer
DATROWAY® (datopotamab deruxtecan) has received EU approval for treating adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have undergone endocrine therapy and at least one chemotherapy line in advanced settings. The approval is based on the TROPION-Breast01 phase 3 trial results.
Key findings show DATROWAY reduced disease progression or death risk by 37% compared to standard chemotherapy. The median progression-free survival was 6.9 months for DATROWAY versus 4.9 months with chemotherapy. The objective response rate was 36% for DATROWAY compared to 23% for chemotherapy, with a median duration of response of 6.7 months versus 5.7 months respectively.
Overall survival results were not statistically significant, with median OS of 18.6 months for DATROWAY versus 18.3 months for chemotherapy. The most common Grade 3 or higher adverse events included stomatitis (7.9%), fatigue (4.3%), and anemia (3.2%).
DATROWAY® (datopotamab deruxtecan) ha ricevuto l'approvazione dell'UE per il trattamento di pazienti adulti con carcinoma mammario HR positivo e HER2 negativo, non resecabile o metastatico, che hanno già ricevuto terapia endocrina e almeno una linea di chemioterapia in contesti avanzati. L'approvazione si basa sui risultati del trial di fase 3 TROPION-Breast01.
I risultati chiave mostrano che DATROWAY ha ridotto il rischio di progressione della malattia o di morte del 37% rispetto alla chemioterapia standard. La sopravvivenza libera da progressione mediana è stata di 6,9 mesi per DATROWAY contro 4,9 mesi con la chemioterapia. Il tasso di risposta obiettiva è stato del 36% per DATROWAY rispetto al 23% per la chemioterapia, con una durata mediana della risposta di 6,7 mesi contro 5,7 mesi rispettivamente.
I risultati di sopravvivenza globale non sono stati statisticamente significativi, con una sopravvivenza globale mediana di 18,6 mesi per DATROWAY contro 18,3 mesi per la chemioterapia. Gli eventi avversi di Grado 3 o superiore più comuni includevano stomatite (7,9%), affaticamento (4,3%) e anemia (3,2%).
DATROWAY® (datopotamab deruxtecan) ha recibido la aprobación de la UE para tratar a pacientes adultos con cáncer de mama HR positivo y HER2 negativo, irresecable o metastásico, que han recibido terapia endocrina y al menos una línea de quimioterapia en etapas avanzadas. La aprobación se basa en los resultados del ensayo de fase 3 TROPION-Breast01.
Los hallazgos clave muestran que DATROWAY redujo el riesgo de progresión de la enfermedad o muerte en un 37% en comparación con la quimioterapia estándar. La mediana de supervivencia libre de progresión fue de 6,9 meses para DATROWAY frente a 4,9 meses con quimioterapia. La tasa de respuesta objetiva fue del 36% para DATROWAY en comparación con el 23% para la quimioterapia, con una duración mediana de respuesta de 6,7 meses frente a 5,7 meses, respectivamente.
Los resultados de supervivencia global no fueron estadísticamente significativos, con una supervivencia global mediana de 18,6 meses para DATROWAY frente a 18,3 meses para la quimioterapia. Los eventos adversos más comunes de Grado 3 o superior incluyeron estomatitis (7,9%), fatiga (4,3%) y anemia (3,2%).
DATROWAY® (다포타맙 데룩스테칸)은 내수술성 또는 전이성 HR 양성, HER2 음성 유방암 성인 환자 치료를 위해 EU 승인을 받았습니다. 이 환자들은 호르몬 요법을 받았고, 고급 단계에서 최소한 한 번의 화학요법을 받았습니다. 승인은 TROPION-Breast01 3상 시험의 결과를 기반으로 합니다.
주요 결과는 DATROWAY가 표준 화학요법에 비해 질병 진행 또는 사망 위험을 37% 감소시켰음을 보여줍니다. DATROWAY의 중앙 무진행 생존 기간은 6.9개월로, 화학요법의 4.9개월과 비교됩니다. DATROWAY의 객관적 반응률은 36%로, 화학요법의 23%와 비교되며, 반응 지속 시간은 각각 6.7개월 대 5.7개월입니다.
전체 생존 결과는 통계적으로 유의미하지 않았으며, DATROWAY의 중앙 전체 생존 기간은 18.6개월, 화학요법은 18.3개월이었습니다. 가장 흔한 3등급 이상의 부작용으로는 구내염(7.9%), 피로(4.3%), 빈혈(3.2%)이 포함되었습니다.
DATROWAY® (datopotamab deruxtecan) a reçu l'approbation de l'UE pour traiter des patients adultes atteints d'un cancer du sein HR positif et HER2 négatif, non résécable ou métastatique, ayant déjà subi une thérapie endocrinienne et au moins une ligne de chimiothérapie dans des contextes avancés. L'approbation repose sur les résultats de l'
Les résultats clés montrent que DATROWAY a réduit le risque de progression de la maladie ou de décès de 37% par rapport à la chimiothérapie standard. La survie médiane sans progression était de 6,9 mois pour DATROWAY contre 4,9 mois avec la chimiothérapie. Le taux de réponse objective était de 36% pour DATROWAY contre 23% pour la chimiothérapie, avec une durée médiane de réponse de 6,7 mois contre 5,7 mois respectivement.
Les résultats de survie globale n'étaient pas statistiquement significatifs, avec une survie globale médiane de 18,6 mois pour DATROWAY contre 18,3 mois pour la chimiothérapie. Les événements indésirables de Grade 3 ou supérieur les plus courants comprenaient la stomatite (7,9%), la fatigue (4,3%) et l'anémie (3,2%).
DATROWAY® (Datopotamab Deruxtecan) hat die Genehmigung der EU zur Behandlung von erwachsenen Patienten mit nicht resektablem oder metastasiertem HR-positivem, HER2-negativem Brustkrebs erhalten, die eine endokrine Therapie und mindestens eine Chemotherapie in fortgeschrittenen Stadien durchlaufen haben. Die Genehmigung basiert auf den Ergebnissen der TROPION-Breast01 Phase-3-Studie.
Wichtige Ergebnisse zeigen, dass DATROWAY das Risiko für Krankheitsprogression oder Tod um 37% im Vergleich zur Standardchemotherapie reduziert hat. Die mediane progressionsfreie Überlebenszeit betrug 6,9 Monate für DATROWAY im Vergleich zu 4,9 Monaten bei der Chemotherapie. Die objektive Ansprechrate betrug 36% für DATROWAY im Vergleich zu 23% für die Chemotherapie, mit einer medianen Ansprechdauer von 6,7 Monaten gegenüber 5,7 Monaten.
Die Ergebnisse zum Gesamtüberleben waren statistisch nicht signifikant, mit einer medianen OS von 18,6 Monaten für DATROWAY im Vergleich zu 18,3 Monaten für die Chemotherapie. Die häufigsten unerwünschten Ereignisse der Grade 3 oder höher umfassten Stomatitis (7,9%), Müdigkeit (4,3%) und Anämie (3,2%).
- 37% reduction in disease progression or death risk compared to chemotherapy
- Higher objective response rate of 36% vs 23% for chemotherapy
- Longer progression-free survival of 6.9 months vs 4.9 months
- Represents second ADC approved for breast cancer using DXd technology
- No statistically significant improvement in overall survival (18.6 vs 18.3 months)
- Grade 5 adverse events occurred in 0.7% of patients
- Relatively short duration of response at 6.7 months
Insights
The EU approval of DATROWAY for previously treated HR+/HER2- metastatic breast cancer represents a clinically meaningful advancement in this difficult-to-treat population. The 37% reduction in progression risk (HR=0.63) and 2-month PFS improvement (6.9 vs 4.9 months) over chemotherapy in TROPION-Breast01 demonstrate meaningful efficacy in patients who have progressed on endocrine therapy and prior chemotherapy.
This antibody-drug conjugate (ADC) targeting TROP2 achieved a 36% response rate versus 23% with chemotherapy, offering an important alternative for patients with options. However, the lack of overall survival benefit (18.6 vs 18.3 months, HR 1.01) is a significant limitation, though this may have been confounded by subsequent ADC treatments.
The safety profile shows manageable toxicity with stomatitis (
While not paradigm-shifting given the OS results, DATROWAY offers an important additional option in the treatment sequence for HR+/HER2- breast cancer, which represents approximately
AstraZeneca's EU approval for DATROWAY strengthens its growing oncology franchise and advances its strategic partnership with Daiichi Sankyo. This marks their second jointly-developed ADC approved in Europe, following the success of Enhertu, and represents the third approval from Daiichi Sankyo's DXd platform.
The commercial opportunity is significant, targeting the HR+/HER2- segment that comprises the majority of breast cancer cases. As a later-line therapy for metastatic disease, DATROWAY addresses a substantial patient population with effective options after progression on endocrine therapy and initial chemotherapy.
However, market adoption may be tempered by the lack of overall survival benefit in the pivotal trial, which could impact reimbursement negotiations and physician adoption, particularly in Europe's cost-sensitive markets. The superior progression-free survival and response rates provide compelling value propositions, but payers will scrutinize the cost-effectiveness without an OS advantage.
Strategically, this approval further validates AstraZeneca's substantial investment in ADC technology and oncology, while expanding its breast cancer portfolio beyond Enhertu. DATROWAY contributes to AstraZeneca's diversification within oncology and demonstrates continued execution on its pipeline. The company's growing presence in precision oncology strengthens its competitive position against rivals like Pfizer/Seagen and Gilead/Immunomedics who are also developing TROP2-directed therapies.
-
First approval in the EU for Daiichi Sankyo and AstraZeneca’s DATROWAY based on TROPION-Breast01 trial showing
37% reduction in the risk of disease progression or death versus chemotherapy - Second DXd antibody drug conjugate approved in EU based on Daiichi Sankyo’s DXd technology
DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).
The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast01 phase 3 trial.
In TROPION-Breast01, DATROWAY significantly reduced the risk of disease progression or death by
“With the majority of breast cancer cases historically considered HR positive, HER2 negative, additional treatment options are needed to improve outcomes for patients with metastatic disease that continues to progress following endocrine-based therapy and initial chemotherapy,” said Barbara Pistilli, MD, Head of the Breast Cancer Unit in the Medical Oncology Department of Gustave Roussy Cancer Center, Villejuif,
“Treating metastatic HR positive, HER2 negative breast cancer presents challenges, particularly treatment resistance and disease progression that occur following endocrine-based therapy and initial chemotherapy,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “DATROWAY represents the second antibody drug conjugate approved for breast cancer based on Daiichi Sankyo’s DXd technology and the third medicine to be approved in the EU from our oncology pipeline, underscoring our commitment to creating new medicines for patients with cancer.”
“Though the HR positive breast cancer treatment landscape has evolved in the last several years, disease progression on front-line therapies remains a common and complex challenge for patients with metastatic disease,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “With today’s approval of DATROWAY, patients in the EU with HR positive, HER2 negative breast cancer now have a new and needed alternative to conventional chemotherapy.”
Grade 3 or higher adverse events from a pooled safety analysis of two clinical studies, including 443 patients who received DATROWAY (6 mg/kg) for a median duration of 6.2 months (range: 0.7-28.5), were stomatitis (
About TROPION-Breast01
TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease.
Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.
The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.
TROPION-Breast01 enrolled 732 patients in
About Hormone Receptor Positive, HER2 Negative Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.1 In
Approximately
About DATROWAY
DATROWAY (datopotamab deruxtecan) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
DATROWAY is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results of the TROPION-Breast01 trial.
About the DATROWAY Clinical Development Program
A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings.
About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU® in March 2019 and DATROWAY in July 2020, except in
About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.
The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc,
The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.
Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About Daiichi Sankyo
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.
| ____________________ |
References: |
1 Bray F, et al. CA Cancer J Clin. 2024; 10.3322/caac.21834. |
2 Globocan 2022. |
3 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed April 2025. |
4 Manohar P, et al. Cancer Biol Med. 2022 Feb 15; 19(2):202–212. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250407125323/en/
Media Contacts:
Global:
Jennifer Brennan
Daiichi Sankyo, Inc.
jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)
EU:
Simone Jendsch-Dowé
Daiichi Sankyo Europe GmbH
simone.jendsch-dowe@daiichisankyo.com
+49 176 11780822
Daiichi Sankyo Co., Ltd.
DS-PR_jp@daiichisankyo.com
Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com
Source: Daiichi Sankyo
FAQ
What were the key efficacy results of DATROWAY in the TROPION-Breast01 trial for AZN?
What is the specific patient population approved for DATROWAY treatment in the EU?
What were the major safety concerns observed with DATROWAY in clinical trials?
How did DATROWAY perform in terms of overall survival in the trial?
