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Peer-reviewedCC BYNature Cancer

First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial

  • Peter Schmid1
  • Seock‐Ah Im2
  • Zbigniew Nowecki3
  • Piotr Jan Wysocki4
  • Jacek Jassem5
  • Kyung Hae Jung6
  • Simon Lord7
  • Jon M. Armstrong8
  • Ross A. Stewart8
  • Petra Vuković8
  • Neelima Denduluri9
  • Yeon Hee Park10
10 affiliations
  1. 1Barts Cancer Institute, Queen Mary University of London, London, UK. [email protected]
  2. 2Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea
  3. 3Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland
  4. 4Department of Oncology, Jagiellonian University - Medical College, Krakow, Poland
  5. 5Medical University of Gdańsk, Gdańsk, Poland
  6. 6Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea
  7. 7Medical Sciences Division, University of Oxford, Oxford, UK
  8. 8AstraZeneca, Cambridge, UK
  9. 9AstraZeneca, Gaithersburg, MD, USA
  10. 10Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
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Abstract

More effective therapies are required for advanced breast cancer. We report results from 58 women with locally advanced unresectable or metastatic hormone-receptor (HR)-negative, human epidermal growth factor receptor 2 (HER2)-low breast cancer enrolled in arm 6 of the multicenter, open-label phase 1b/2 BEGONIA platform trial, who received durvalumab (1,120 mg) plus trastuzumab deruxtecan (T-DXd; 5.4 mg kg −1 ) intravenously every 3 weeks as first-line treatment. Objective response rate (ORR) and safety were primary endpoints; duration of response (DoR), progression-free survival (PFS) and overall survival (OS) were secondary endpoints. Median follow-up was 20.6 months (range: 1–37). ORR was 62.1% (95% confidence interval (CI): 48.4–74.5), which did not meet the protocol-specified objective of 38/57 (66.6%) responses. Median DoR was 15.2 months (95% CI: 8.44–not calculable), PFS was 12.6 months (95% CI: 8.4–16.3) and OS was 30.3 months (95% CI: 18.8–not calculable). The safety profile of the combination treatment was consistent with those of the individual therapies. Adjudicated, drug-related interstitial lung disease or pneumonitis occurred in 20.7% of participants (grades 1 and 2, 19.0%; grade 5, 1.7%). Durvalumab plus T-DXd demonstrated clinically relevant efficacy for first-line treatment of metastatic HR-negative, HER2-low breast cancer, with no unexpected toxicities observed. ClinicalTrials.gov identifier: NCT03742102 .

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Cite

BibTeXRIS
BibTeX
@article{schmid2026firstline,
  title = {{First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial}},
  author = {Peter Schmid and Seock‐Ah Im and Zbigniew Nowecki and Piotr Jan Wysocki and Jacek Jassem and Kyung Hae Jung and Simon Lord and Jon M. Armstrong and Ross A. Stewart and Petra Vuković and Neelima Denduluri and Yeon Hee Park},
  journal = {Nature Cancer},
  year = {2026},
  month = jun,
  doi = {10.1038/s43018-026-01181-8},
  url = {https://doi.org/10.1038/s43018-026-01181-8},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial
AU  - Peter Schmid
AU  - Seock‐Ah Im
AU  - Zbigniew Nowecki
AU  - Piotr Jan Wysocki
AU  - Jacek Jassem
AU  - Kyung Hae Jung
AU  - Simon Lord
AU  - Jon M. Armstrong
AU  - Ross A. Stewart
AU  - Petra Vuković
AU  - Neelima Denduluri
AU  - Yeon Hee Park
PY  - 2026
DA  - 2026/06/08
JO  - Nature Cancer
DO  - 10.1038/s43018-026-01181-8
UR  - https://doi.org/10.1038/s43018-026-01181-8
AB  - More effective therapies are required for advanced breast cancer. We report results from 58 women with locally advanced unresectable or metastatic hormone-receptor (HR)-negative, human epidermal growth factor receptor 2 (HER2)-low breast cancer enrolled in arm 6 of the multicenter, open-label phase 1b/2 BEGONIA platform trial, who received durvalumab (1,120 mg) plus trastuzumab deruxtecan (T-DXd; 5.4 mg kg −1 ) intravenously every 3 weeks as first-line treatment. Objective response rate (ORR) and safety were primary endpoints; duration of response (DoR), progression-free survival (PFS) and overall survival (OS) were secondary endpoints. Median follow-up was 20.6 months (range: 1–37). ORR was 62.1% (95% confidence interval (CI): 48.4–74.5), which did not meet the protocol-specified objective of 38/57 (66.6%) responses. Median DoR was 15.2 months (95% CI: 8.44–not calculable), PFS was 12.6 months (95% CI: 8.4–16.3) and OS was 30.3 months (95% CI: 18.8–not calculable). The safety profile of the combination treatment was consistent with those of the individual therapies. Adjudicated, drug-related interstitial lung disease or pneumonitis occurred in 20.7% of participants (grades 1 and 2, 19.0%; grade 5, 1.7%). Durvalumab plus T-DXd demonstrated clinically relevant efficacy for first-line treatment of metastatic HR-negative, HER2-low breast cancer, with no unexpected toxicities observed. ClinicalTrials.gov identifier: NCT03742102 .
SN  - 2662-1347
ER  -