Datroway Improves Survival in Advanced Triple-Negative Breast Cancer Trial

Datroway (datopotamab deruxtecan; Dato-DXd) significantly improved the time patients lived without their disease worsening and overall survival compared to standard chemotherapy in patients with previously untreated, advanced triple-negative breast cancer (TNBC) who were not eligible for immunotherapy.

These findings — from the international phase III TROPION-Breast02 between May 2022 and June 2024 across 229 centers in 23 countries — were published in Annals of Oncology. The study sought to address the limited treatment options for this aggressive form of breast cancer, particularly for the approximately 70% of patients who cannot receive immunotherapy.

Main data that support the findings

The study reached its primary goals by showing that Datroway outperformed investigator’s choice of chemotherapy in several key metrics:

• Progression-Free Survival: Patients treated with Datroway experienced a median progression-free survival of 10.8 months, compared to 5.6 months for those receiving chemotherapy. This represents a nearly five-and-a-half-month improvement in the time patients lived before the cancer began to grow again.
• Overall Survival: The median overall survival was 23.7 months in the Datroway group versus 18.7 months in the chemotherapy group, showing a five-month survival advantage.
• Tumor Response: The confirmed objective response rate, the percentage of patients whose tumors shrank or disappeared, was 63% for those on Datroway compared to 29% for those on chemotherapy.
• Complete Response: Nine percent of patients in the Datroway arm had a complete response (no detectable signs of cancer), compared to 2% in the chemotherapy arm.
• Duration of Response: For patients who responded to treatment, the median duration of that response was 12.3 months with Datroway, nearly double the 7.1 months seen with chemotherapy.

Trial details

The TROPION-Breast02 trial enrolled 644 patients with locally recurrent inoperable or metastatic TNBC who had not received prior therapy for their advanced disease. Participants were randomly assigned to receive either Datroway (323 patients) or chemotherapy (321 patients).

The chemotherapy group received options including nab-paclitaxel, paclitaxel, eribulin, carboplatin or capecitabine. The study included patients often excluded from other trials, such as those with brain metastases or those whose cancer returned within six months of completing their initial treatment.

Datroway is an antibody-drug conjugate. This type of therapy works by using a monoclonal antibody to find and bind to a specific protein (TROP2) on the surface of cancer cells, where it then releases a potent medicine directly into the cell to destroy it.

Safety

The safety profile of Datroway was consistent with previous studies, and while patients remained on Datroway for a median of 8.5 months — more than twice as long as the 4.1 months in the chemotherapy group — serious side effects were similar between the two groups.

Treatment-related side effects occurred in 296 (93%) and 257 (83%) patients who received Datroway and chemotherapy, respectively. Treatment-related side effects of grade 3 (severe) or higher were reported in 105 (33%) and 89 (29%) patients, respectively. Fewer patients stopped treatment due to side effects in the Datroway group (14 patients; 4%) than in the chemotherapy group (23 patients; 7%). No treatment-related deaths occurred in either group.

Common side effects for patients receiving Datroway included:

• Stomatitis (mouth sores): 57%
• Nausea: 45%
• Alopecia (hair loss): 41%
• Fatigue: 32%
• Dry eye: 24%

For those receiving chemotherapy, the most frequent side effects were hair loss (31%), neutropenia (low white blood cell counts; 29%), and fatigue (28%).

Researchers noted specific side effects of interest for Datroway, including ocular surface events (mostly mild dry eye) and a 3% rate of drug-related lung inflammation (interstitial lung disease or pneumonitis). Most of these lung-related events were low-grade, though one patient had a fatal event that was assessed as related to the study drug. Patients also reported better outcomes regarding pain and physical functioning while on Datroway compared to those on chemotherapy.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

Reference

“Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial” by Rebecca A. Dent, et al., Annals of Oncology.

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