{ "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.", "abstract_shown": true, "affiliations": [ "Centre for Experimental Cancer Care Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: p.schmid@qmul.ac.uk", "Department of Surgery, China Medical University Hospital, Taichung, Taiwan", "Department of Medical Oncology, Breast Oncology Program, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, USA", "Medical Oncology, McGill University Health Centre, Montreal, QC, Canada", "Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea", "Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA", "Division of Hematology Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea", "Division of Breast Surgery, Department of General Surgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan", "Department of Oncology, Jagiellonian University Medical College, Krakow, Poland", "Cancer Research UK Cambridge Centre, Cambridge, UK", "Breast Surgery, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland", "Division of Medical Oncology, Verspeeten Family Cancer Centre, London Health Sciences Centre, University of Western Ontario, London, ON, Canada", "Baylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute, Dallas, TX, USA", "Department of Oncology, Medical Sciences Division, University of Oxford, Oxford, UK", "Division of Breast Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan", "Comprehensive Breast Health Center, Taipei Veterans General Hospital, Taipei, Taiwan", "Oncology, Sherbrooke University, Centre Intégré de Cancérologie de la Montérégie, CISSS Montérégie Centre, Greenfield Park, QC, Canada", "Statistics, Oncology R&D, AstraZeneca, Mississauga, ON, Canada", "Translational Medicine, Oncology R&D, AstraZeneca, Cambridge, UK", "Clinical Development, Oncology R&D, AstraZeneca, Warsaw, Poland", "Clinical Development, Oncology R&D, AstraZeneca, Cambridge, UK", "Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea" ], "article_type": null, "arxiv": null, "author_total": 22, "authors": [ { "affs": [ 0 ], "name": "P. Schmid" }, { "affs": [ 1 ], "name": "H.-C. Wang" }, { "affs": [ 2 ], "name": "Filipa C. Lynce", "orcid": "0000-0001-6615-7076" }, { "affs": [ 3 ], "name": "J. Asselah" }, { "affs": [ 4 ], "name": "K.H. Jung", "orcid": "0000-0002-1580-7224" }, { "affs": [ 5 ], "name": "C.X. Ma" }, { "affs": [ 6 ], "name": "Y.H. Park", "orcid": "0000-0003-4156-9212" }, { "affs": [ 7 ], "name": "Shin‐Cheh Chen", "orcid": "0000-0002-0177-0045" }, { "affs": [ 8 ], "name": "Piotr Jan Wysocki", "orcid": "0000-0003-4003-5278" }, { "affs": [ 9 ], "name": "Richard D. Baird", "orcid": "0000-0001-7071-6483" }, { "affs": [ 10 ], "name": "Z. I. Nowecki" }, { "affs": [ 11 ], "name": "R Fernandes" }, { "affs": [ 12 ], "name": "Joyce O’Shaughnessy", "orcid": "0000-0002-2955-5523" }, { "affs": [ 13 ], "name": "S. Lord", "orcid": "0000-0001-7946-5609" }, { "affs": [ 14 ], "name": "M.-F. HOU" }, { "affs": [ 15 ], "name": "L-M Tseng" }, { "affs": [ 16 ], "name": "Catherine C. M. Prady" }, { "affs": [ 17 ], "name": "Purnima Rao-Melacini", "orcid": "0009-0000-5426-451X" }, { "affs": [ 18 ], "name": "R. Stewart" }, { "affs": [ 19 ], "name": "Karola Warzyszyńska", "orcid": "0000-0002-6083-896X" }, { "affs": [ 20 ], "name": "Petra Vuković" }, { "affs": [ 21 ], "name": "Seock‐Ah Im", "orcid": "0000-0002-5396-6533" } ], "bibtex": "https://research.draconitic.com/paper/bmx8b12bpn2e6.bib", "cited_by": 13, "doi": "10.1016/j.annonc.2026.05.693", "fulltext_url": null, "id": "bmx8b12bpn2e6", "issns": [ "0923-7534", "1569-8041" ], "landing_url": "https://doi.org/10.1016/j.annonc.2026.05.693", "language": "en", "licence": "CC-BY", "licence_label": "CC BY", "licence_source": "journal", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "openalex", "2730|Cancer Immunotherapy and Biomarkers" ] ], "openalex": "W7161762707", "pdf_url": "https://www.annalsofoncology.org/article/S0923-7534(26)00877-X/pdf", "pmcid": null, "pmid": "42167437", "published": "2026-05-20", "publisher": "Elsevier BV", "ris": "https://research.draconitic.com/paper/bmx8b12bpn2e6.ris", "sources": [ { "first_seen": "2026-11-05T13:21:08Z", "native_id": "W7161762707", "source": "openalex", "url": "https://doi.org/10.1016/j.annonc.2026.05.693" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2730|Cancer Immunotherapy and Biomarkers", "subfield": "oncology" } ], "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", "title_text": "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", "type": "peer-reviewed", "updated_at": "2026-11-09T13:21:16Z", "url": "https://research.draconitic.com/paper/bmx8b12bpn2e6", "venue": "Annals of Oncology", "versions": [] }