Datroway Improves Progression, Survival in Triple-Negative Breast Cancer

Among patients with locally recurrent inoperable or metastatic triple-negative breast cancer for whom immunotherapy was not a treatment option, treatment with Datroway (datopotamab deruxtecan-dlnk) was associated with a statistically significant and clinically meaningful improvement in both overall survival and progression-free survival compared to chemotherapy as a first-line treatment, study results have shown.

Positive high-level results from the TROPION-Breast02 phase 3 clinical trial were announced in a news release issued by AstraZeneca, which stated that AstraZeneca and Daiichi Sankyo’s Datroway is the first therapy shown to improve overall survival versus chemotherapy among members of this patient population.

The news release stated that approximately 70% of patients with metastatic triple-negative breast cancer are not candidates for treatment with immunotherapy, including all patients with tumors that do not express PD-L1, for whom chemotherapy remains the first-line standard of care.

“TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option,” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said in the news release. “We expect today’s results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options.”

Ken Takeshita, global head of research and development at Daiichi Sankyo, expanded on the meaning of these results in the announcement.

“These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development program for Datroway in triple-negative breast cancer and other tumor types,” said Takeshita. “We look forward to discussing these data with global regulatory authorities and to bringing Datroway to patients with triple-negative breast cancer as soon as possible.”

According to the news release, the safety profile of Datroway was consistent with previous clinical trials of the drug in breast cancer, and these data will be presented at an upcoming medical meeting and shared with regulatory authorities.

More About Datroway and Breast Cancer

The news release details that Datroway is a TROP2-directed DXd antibody-drug conjugate discovered by Daiichi Sankyo and developed and commercialized by AstraZeneca and Daiichi Sankyo that is being evaluated in different stages and treatment settings of triple-negative breast cancer in three additional phase 3 trials.

Datroway, according to the National Cancer Institute, contains a monoclonal antibody, datopotamab, that binds to the protein TROP2 which is found on some cancer cells, and also contains an anticancer drug called deruxtecan, which may help kill cancer cells.

Dr. Yuan Yuan, a professor of medicine, director of Breast Oncology and medical director of Breast Cancer Research at Cedars-Sinai Medical Center in Los Angeles, as well as a health sciences clinical professor at UCLA, previously spoke with CURE about how antibody-drug conjugates are used to treat breast cancer.

“I usually describe antibody-drug conjugates as a new class of designer drug, where the target-specific antibody was attached to a small amount of chemotherapy [payload], in contrast to conventional chemotherapy with a larger amount of drug to enter the body,” says Yuan. “Here, the idea is to do a cancer cell-specific delivery.”

Earlier this year, the U.S. Food and Drug Administration approved Datroway for adults with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Reference:

1. “DATROWAY® (datopotamab deruxtecan-dlnk) demonstrated statistically significant and clinically meaningful improvement in overall survival as 1st-line therapy for patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option in TROPION-Breast02,” news release; https://www.astrazeneca-us.com/media/press-releases/2025/DATROWAY-datopotamab-deruxtecan-dlnk-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-overall-survival-as-1st-line-therapy-for-patients-with-metastatic-triple-negative-breast-cancer-for-whom-immunotherapy-was-not-an-option-in-TROPION-Breast02.html
2. “Datroway,” https://www.cancer.gov/publications/dictionaries/cancer-terms/def/datroway
3. “Finding Hope With Antibody-Drug Conjugates in Managing Breast Cancer,” CURE; https://www.curetoday.com/view/finding-hope-with-antibody-drug-conjugates-in-managing-breast-cancer
4. “FDA Approves Datroway for HR+, HER2- Breast Cancer,” CURE; https://www.curetoday.com/view/fda-approves-datroway-for-hr-her2--breast-cancer

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