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William J. Gradishar, MD, FACP, FASCO


Update on Use of Dato-DXd Plus Durvalumab in Triple-Negative Breast Cancer

By: Julia Fiederlein Cipriano, MS
Posted: Monday, November 13, 2023

According to Peter Schmid, MD, PhD, of Barts Cancer Institute, London, and colleagues, first-line treatment with the TROP-2–directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) plus the anti–PD-L1 antibody durvalumab appeared to be safe and active in patients with unresectable locally advanced or metastatic triple-negative breast cancer. These updated results from arm 7 of the ongoing, two-part, phase Ib/II BEGONIA trial, which were presented during the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract 379MO), support previous findings.

“Further investigation is warranted,” the investigators concluded. “Translational data analysis is ongoing.”

As of February 2023, a total of 62 patients were intravenously treated with 6 mg/kg of Dato-DXd plus 1,120 mg of durvalumab every 3 weeks until disease progression or unacceptable toxicity. Follow-up data were provided for a median of 11.7 months.

The confirmed objective response rate was 79%; a total of 6 complete responses and 43 partial responses were observed. According to the investigators, the recorded responses were independent of PD-L1 expression levels. The median durations of response and progression-free survival were 15.5 and 13.8 months, respectively.

Nausea and stomatitis (65% each) were the most frequently observed adverse events with the immunotherapy combination. Grade 3 or 4 and serious adverse events were documented in 57% and 23% of patients, respectively. The investigators reported low rates of anemia (15%), diarrhea (13%), and neutropenia (5%). Three patients experienced adjudicated, treatment-related interstitial lung disease or pneumonitis. Treatment-related deaths were not documented in this study population. A total of 16% of patients discontinued any study drug because of adverse events. No new safety signals were identified.

Disclosure: For full disclosures of the study authors, visit

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