Datroway: 37% Reduction In The Risk Of Death VS Chemotherapy

Based on the TROPION-Breast01 trial, Daiichi Sankyo and AstraZeneca’s DATROWAY was approved for the first time in the European Union.

The trial showed a 37% reduction in the risk of disease progression or death compared to chemotherapy.

What Is Datroway?

DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the European Union (EU) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) advanced unresectable or metastatic breast cancer who have received endocrine therapy and at least one line of chemotherapy.

Dartoway is a TROP2-targeted ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, it is one of six DXd ADCs in the Daiichi Sankyo Oncology Pipeline and one of the most advanced programs in AstraZeneca’s ADC scientific platform.

Datopotamab deruxtecan-dlnk is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody developed in collaboration with the Sapporo Medical University.

It consists of a humanized anti-TROP2 IgG1 monoclonal antibody developed in collaboration with Sapporo Medical University, which is linked to multiple topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via a cleavable tetrapeptide-based linker.

Clinical Trial Results For Datroway

This clinical trial includes adult patients with HR+/HER2- breast cancer who have been treated with endocrine therapy and chemotherapy for breast cancer that is either unresectable (cannot be removed surgically) or metastatic (has spread to other parts of the body).

✅Progression-Free Survival (PFS): Patients treated with Datroway experienced a median PFS of 6.9 months, compared to 4.9 months in the chemotherapy group.

This corresponds to a 37% reduction in the risk of disease progression or death (Hazard Ratio [HR] = 0.63; 95% Confidence Interval [CI]: 0.52–0.76; p < 0.0001).

✅Overall Survival (OS): Median OS was 18.6 months for Datroway and 18.3 months for chemotherapy. The difference was not statistically significant (HR = 1.01; 95% CI: 0.83–1.22).

✅Objective Response Rate (ORR): Datroway achieved a confirmed ORR of 36%, including 0.5% complete responses and 36% partial responses, compared to 23% ORR in the chemotherapy arm.

✅Duration of Response (DoR): The median DoR was 6.7 months for Datroway recipients, versus 5.7 months for those on chemotherapy.

About TROPION-Breast01

Based on the results of the TROPION-Breast01 trial, DATROWAY has been approved in more than 30 countries for the treatment of adult patients with HR-positive, HER2-negative, unresectable or metastatic breast cancer who have received previous endocrine therapy and chemotherapy.

TROPION-Breast01 is a global, randomized, multicenter, open-label, phase 3 clinical trial.

The trial aims to evaluate the efficacy and safety of intravenous datopotamab deruxtecan-dlnk administered at 6 mg/kg every three weeks.

DATROWAY is compared to the investigator’s choice of single-agent chemotherapy, which includes eribulin, capecitabine, vinorelbine, or gemcitabine.

The study involves adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer.

Eligible patients have progressed on endocrine therapy and are not suitable for further endocrine treatment, as assessed by the investigator.

Participants must have received at least one prior line of chemotherapy for unresectable or metastatic disease.

After disease progression or discontinuation of DATROWAY or chemotherapy, patients may receive subsequent treatment at the discretion of their physician. Crossover treatment between trial groups is not allowed.

The dual primary endpoints for TROPION-Breast01 were PFS and OS as assessed by BICR.

The primary secondary endpoints included ORR, DoR, investigator-assessed PFS, disease control rate, time to first follow-up, and safety.

TROPION-Breast01’s PFS data and other results for the key secondary endpoints were published in the Journal of Clinical Oncology (Journal of Clinical Oncology) and OS results were presented at a virtual plenary session in February 2025 hosted by the European Society of Medical Oncology.

About Female Breast Cancer Subtypes

Female breast cancer is most common in middle-aged and older women. Male breast cancer, although rare, is also possible.

Based on case data from 2018 through 2022, the age-adjusted rate of new cases of female breast cancer for all subtypes combined is 130.8 cases per 100,000 women per year.

There are four main subtypes of female breast cancer, listed below in order of incidence:

• HR+/HER2-
• HR-/HER2-
• HR+/HER2+
• HR-/HER2+

HR stands for hormone receptor. HR+ indicates that the tumor cells have receptors for estrogen or progesterone, hormones that promote the growth of HR+ tumors.

HER2 stands for human epidermal growth factor receptor 2.

HER2+ indicates that the tumor cells produce high levels of the HER2/neu protein, which has been shown to be associated with certain invasive breast cancers.

When all subtypes are combined, female breast cancer is quite common. An additional 316,950 female breast cancer cases are projected in 2025.

The breast cancer subtype HR+/HER2- is the most common subtype, with an age-adjusted rate of 91.3 new cases per 100,000 women based on cases from 2018 through 2022.

Datroway Side Effects

The most common side effects of Datroway medicine include:

⭕nausea

⭕tiredness

⭕decreased white blood cell counts

⭕decreased calcium

⭕hair loss

⭕decreased red blood cell counts

⭕constipation

⭕dry eye

⭕vomiting

⭕increased blood levels of liver enzymes

⭕an eye problem called keratitis

DATROWAY may cause fertility problems in both men and women, which may affect your ability to have children. If you are concerned about fertility problems, talk to your healthcare provider.

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