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Peer-reviewedCC BYAnnals of Oncology

Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: results from arms 7 and 8 of the phase Ib/II BEGONIA study

  • P. Schmid1
  • H.-C. Wang2
  • Filipa C. Lynce3
  • J. Asselah4
  • K.H. Jung5
  • C.X. Ma6
  • Y.H. Park7
  • Shin‐Cheh Chen8
  • Piotr Jan Wysocki9
  • Richard D. Baird10
  • Z. I. Nowecki11
  • R Fernandes12
10 more authors
  • Joyce O’Shaughnessy13
  • S. Lord14
  • M.-F. HOU15
  • L-M Tseng16
  • Catherine C. M. Prady17
  • Purnima Rao-Melacini18
  • R. Stewart19
  • Karola Warzyszyńska20
  • Petra Vuković21
  • Seock‐Ah Im22
22 affiliations
  1. 1Centre for Experimental Cancer Care Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: [email protected]
  2. 2Department of Surgery, China Medical University Hospital, Taichung, Taiwan
  3. 3Department of Medical Oncology, Breast Oncology Program, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, USA
  4. 4Medical Oncology, McGill University Health Centre, Montreal, QC, Canada
  5. 5Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
  6. 6Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA
  7. 7Division of Hematology Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
  8. 8Division of Breast Surgery, Department of General Surgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan
  9. 9Department of Oncology, Jagiellonian University Medical College, Krakow, Poland
  10. 10Cancer Research UK Cambridge Centre, Cambridge, UK
  11. 11Breast Surgery, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland
  12. 12Division of Medical Oncology, Verspeeten Family Cancer Centre, London Health Sciences Centre, University of Western Ontario, London, ON, Canada
  13. 13Baylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute, Dallas, TX, USA
  14. 14Department of Oncology, Medical Sciences Division, University of Oxford, Oxford, UK
  15. 15Division of Breast Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
  16. 16Comprehensive Breast Health Center, Taipei Veterans General Hospital, Taipei, Taiwan
  17. 17Oncology, Sherbrooke University, Centre Intégré de Cancérologie de la Montérégie, CISSS Montérégie Centre, Greenfield Park, QC, Canada
  18. 18Statistics, Oncology R&D, AstraZeneca, Mississauga, ON, Canada
  19. 19Translational Medicine, Oncology R&D, AstraZeneca, Cambridge, UK
  20. 20Clinical Development, Oncology R&D, AstraZeneca, Warsaw, Poland
  21. 21Clinical Development, Oncology R&D, AstraZeneca, Cambridge, UK
  22. 22Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea
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Abstract

BACKGROUND: BEGONIA (NCT03742102) is a phase Ib/II, Simon's 2-stage, open-label, platform study evaluating the safety and efficacy of durvalumab, an anti-programmed death ligand-1 (PD-L1) antibody, combined with novel therapies, as first-line treatment for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Arms 7 and 8 of BEGONIA assessed the combination of datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, with durvalumab. PATIENTS AND METHODS: Arm 7 included patients regardless of tumor PD-L1 expression level. Arm 8 then enrolled patients with PD-L1-high tumors, as determined by local immunohistochemistry-based testing. In Arms 7 and 8, patients received Dato-DXd 6 mg/kg intravenously plus durvalumab 1120 mg intravenously every 3 weeks. Primary endpoints were safety and tolerability, and investigator-assessed confirmed objective response rate (cORR). Secondary endpoints included cORR (Part 1), duration of response (DoR), progression-free survival (PFS) per RECIST 1.1 and overall survival (OS). RESULTS: Overall, 62 and 33 patients had received Dato-DXd and durvalumab in Arms 7 and 8, respectively. At data cutoff (29 November 2024), median study follow-up was 35.0 and 10.7 months in Arms 7 and 8, respectively. In Arm 7, cORR was 79.0% [95% confidence interval (CI) 66.8-88.3], median DoR was 17.6 months (95% CI 10.5-27.3), median PFS was 14.0 months (11.0-21.1) and median OS was not reached. In Arm 8, cORR was 81.8% (95% CI 64.5-93.0). The median DoR and median PFS for Arm 8 were immature given the short median follow-up (8.3 months in censored patients). The safety profile of the combination was manageable, with no new safety signals versus prior studies. CONCLUSIONS: First-line Dato-DXd plus durvalumab demonstrated substantial and durable antitumor activity in locally advanced unresectable or metastatic TNBC, regardless of PD-L1 status.

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    Peter Schmid, Seock‐Ah Im, Zbigniew Nowecki +9
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Cite

BibTeXRIS
BibTeX
@article{schmid2026datopotamab,
  title = {{Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: results from arms 7 and 8 of the phase Ib/II BEGONIA study}},
  author = {P. Schmid and H.-C. Wang and Filipa C. Lynce and J. Asselah and K.H. Jung and C.X. Ma and Y.H. Park and Shin‐Cheh Chen and Piotr Jan Wysocki and Richard D. Baird and Z. I. Nowecki and R Fernandes and Joyce O’Shaughnessy and S. Lord and M.-F. HOU and L-M Tseng and Catherine C. M. Prady and Purnima Rao-Melacini and R. Stewart and Karola Warzyszyńska and Petra Vuković and Seock‐Ah Im},
  journal = {Annals of Oncology},
  year = {2026},
  month = may,
  doi = {10.1016/j.annonc.2026.05.693},
  url = {https://doi.org/10.1016/j.annonc.2026.05.693},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: results from arms 7 and 8 of the phase Ib/II BEGONIA study
AU  - P. Schmid
AU  - H.-C. Wang
AU  - Filipa C. Lynce
AU  - J. Asselah
AU  - K.H. Jung
AU  - C.X. Ma
AU  - Y.H. Park
AU  - Shin‐Cheh Chen
AU  - Piotr Jan Wysocki
AU  - Richard D. Baird
AU  - Z. I. Nowecki
AU  - R Fernandes
AU  - Joyce O’Shaughnessy
AU  - S. Lord
AU  - M.-F. HOU
AU  - L-M Tseng
AU  - Catherine C. M. Prady
AU  - Purnima Rao-Melacini
AU  - R. Stewart
AU  - Karola Warzyszyńska
AU  - Petra Vuković
AU  - Seock‐Ah Im
PY  - 2026
DA  - 2026/05/20
JO  - Annals of Oncology
DO  - 10.1016/j.annonc.2026.05.693
UR  - https://doi.org/10.1016/j.annonc.2026.05.693
AB  - BACKGROUND: BEGONIA (NCT03742102) is a phase Ib/II, Simon's 2-stage, open-label, platform study evaluating the safety and efficacy of durvalumab, an anti-programmed death ligand-1 (PD-L1) antibody, combined with novel therapies, as first-line treatment for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Arms 7 and 8 of BEGONIA assessed the combination of datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, with durvalumab. PATIENTS AND METHODS: Arm 7 included patients regardless of tumor PD-L1 expression level. Arm 8 then enrolled patients with PD-L1-high tumors, as determined by local immunohistochemistry-based testing. In Arms 7 and 8, patients received Dato-DXd 6 mg/kg intravenously plus durvalumab 1120 mg intravenously every 3 weeks. Primary endpoints were safety and tolerability, and investigator-assessed confirmed objective response rate (cORR). Secondary endpoints included cORR (Part 1), duration of response (DoR), progression-free survival (PFS) per RECIST 1.1 and overall survival (OS). RESULTS: Overall, 62 and 33 patients had received Dato-DXd and durvalumab in Arms 7 and 8, respectively. At data cutoff (29 November 2024), median study follow-up was 35.0 and 10.7 months in Arms 7 and 8, respectively. In Arm 7, cORR was 79.0% [95% confidence interval (CI) 66.8-88.3], median DoR was 17.6 months (95% CI 10.5-27.3), median PFS was 14.0 months (11.0-21.1) and median OS was not reached. In Arm 8, cORR was 81.8% (95% CI 64.5-93.0). The median DoR and median PFS for Arm 8 were immature given the short median follow-up (8.3 months in censored patients). The safety profile of the combination was manageable, with no new safety signals versus prior studies. CONCLUSIONS: First-line Dato-DXd plus durvalumab demonstrated substantial and durable antitumor activity in locally advanced unresectable or metastatic TNBC, regardless of PD-L1 status.
SN  - 0923-7534
SN  - 1569-8041
ER  -