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Proffered Paper session: Breast cancer, metastatic

LBA76 - Overall survival (OS) results from the phase III TROPiCS-02 study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with HR+/HER2- metastatic breast cancer (mBC)


09 Sep 2022


Proffered Paper session: Breast cancer, metastatic


Tumour Site

Breast Cancer


Hope Rugo


Annals of Oncology (2022) 33 (suppl_7): S808-S869. 10.1016/annonc/annonc1089


H.S. Rugo1, A. Bardia2, F. Marmé3, J. Cortés4, P. Schmid5, D. Loirat6, O. Tredan7, E.M. Ciruelos8, F. Dalenc9, P. Gomez Pardo10, K. Jhaveri11, R.J. Delaney12, T. Valdez13, H. Wang14, W. Verret15, S.M. Tolaney16

Author affiliations

  • 1 Department Of Medicine, University of California-San Francisco, Helen Diller Family Comprehensive Cancer Center, 94115 - San Francisco/US
  • 2 Medical Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, 02114 - Boston/US
  • 3 Gynecologic Oncology Department, Medical Faculty Mannheim, Heidelberg University, Department of Obstetrics and Gynaecology, 68167 - Mannheim/DE
  • 4 Medical Oncology Department, International Breast Cancer Center (IBCC), Pangaea Oncology, Quirosalud Group, Madrid & Barcelona, Spain, Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, 28034 - Madrid/ES
  • 5 Centre Of Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, EC1M 6BQ - London/GB
  • 6 Medical Oncology Department And D3i, Institut Curie, 75005 - Paris/FR
  • 7 Medical Oncology Department, Centre Léon Bérard, 69008 - Lyon/FR
  • 8 Medical Oncology, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 9 Medical Oncology, Institut Claudius Régaud, 31052 - Toulouse/FR
  • 10 Medical Oncology, Hospital Universitari Vall D'Hebron, 8035 - Barcelona/ES
  • 11 Medical Oncology, Memorial Sloan-Kettering Cancer Center (MSKCC), 10065 - New York/US
  • 12 Department Of Clinical Development, Gilead Sciences, Inc., 94404 - Foster City/US
  • 13 Global Patient Safety, Gilead Sciences, Inc., 33126 - Foster City/US
  • 14 Clinical Data Science, Gilead Sciences, Inc., 94404 - Foster City/US
  • 15 Department Of Clinical Development, Gilead Sciences, Inc., 33126 - Foster City/US
  • 16 Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, 02215 - Boston/US


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Abstract LBA76


Pts with HR+/HER2- mBC are treated with endocrine-based therapy (ET), followed by single-agent chemotherapy (CT), with increasingly shorter durations of benefit. SG is an anti–Trop-2 antibody-drug conjugate approved for triple-negative mBC with ≥2 prior therapies (≥1 in the metastatic setting). In TROPiCS-02 (NCT03901339), SG showed significant progression-free survival (PFS) benefit vs TPC in ET resistant HR+/HER2- mBC (HR, 0.66; P<0.001; median 5.5 vs 4.0 mo; Rugo, et al. ASCO 2022). Here, we report the planned TROPiCS-02 OS 2nd interim analysis.


Eligible pts with HR+/HER2- mBC who received prior taxane, ET, CDK4/6 inhibitor, and 2-4 prior CTs were randomized 1:1 to receive SG (10 mg/kg IV d1 and 8, every 21d) or TPC until progression or unacceptable toxicity. Primary endpoint was PFS by BICR with key secondary endpoint of OS. Per protocol, OS was analyzed after ∼350 events. In the statistical testing hierarchy, objective response rate (ORR) and pt-reported outcomes are tested sequentially if OS is significant.


In total, 543 pts were randomized to receive SG (n=272) vs TPC (n=271). Pts had a median of 3 prior CTs for mBC; 95% had visceral metastases. At data cut-off on July 1, 2022 (median follow-up,12.5 mo), 390 OS events occurred. SG significantly improved OS (median 14.4 vs 11.2 mo; HR, 0.79; P=0.020), ORR, global health status/QoL, and fatigue vs TPC (Table). Safety of SG was consistent with prior reports with no new safety signals identified. Table: 000LBA76

SG (n=272) TPC (n=271)
Median OS, mo 14.4 11.2
HR (95% CI) 0.79 (0.65-0.96), P=0.02
ORR, n (%) 57 (21) 38 (14)
Odds ratio (95% CI) 1.63 (1.03-2.56), P=0.035
Median DOR, mo (95% CI) 8.1 (6.7-9.1) 5.6 (3.8-7.9)
TTD of Global Health Score / Quality of Life,a mo 4.3 3.0
HR (95% CI) 0.75 (0.61-0.92), P=0.006
TTD of Fatigue,a mo 2.2 1.4
HR (95% CI) 0.73 (0.60-0.89), P=0.002
TTD of Pain,a mo 3.8 3.5
HR (95% CI) 0.92 (0.75-1.13), P=0.42

aAssessed by EORTC QLQ-C30DOR, duration of response; TTD, time-to-deterioration.


SG demonstrated statistically significant and clinically meaningful improvement in OS, and significant improvement in ORR and QoL vs TPC with manageable safety in pts with ET-resistant HR+/HER2- mBC, a population with limited treatment options. These data support the use of SG as a novel therapy for pts with pre-treated HR+/HER2- mBC.

Clinical trial identification


Editorial acknowledgement

Shala Thomas from Team Sciences provided editorial support.

Legal entity responsible for the study

Gilead Sciences, Inc.


Gilead Sciences, Inc.


H.S. Rugo: Financial Interests, Institutional, Other, Honoraria: Puma Biotechnology, Mylan, Samsung BioepisBioepis; Financial Interests, Institutional, Research Grant: Macrogenics, OBI Pharma, Pfizer, Novartis, Lilly, Genentech, Merck, Odonate Therapeutics, Daiichi Sankyo, Seattle Genetics, Sermonix Pharmaceuticals, AstraZeneca, Gilead Sciences, Ayala Pharmaceuticals. A. Bardia: Financial Interests, Institutional, Research Grant: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health/Menarini, Immunomedics/Gilead, Daiichi Pharma/Astra Zeneca, Eli Lilly].; Financial Interests, Institutional, Other, Consulting Fees: Pfizer, Novartis, Genentech, Merck, Radius Health/Menarini, Immunomedics/Gilead, Sanofi, Daiichi Pharma/Astra Zeneca, Phillips, Eli Lilly, Foundation Medicine]. F. Marmé: Financial Interests, Institutional, Research Grant: Roche, Novartis, AstraZeneca, GSK/Tesaro, MED, Clovis, Vaccibody, Gilead Sciences, Eisai; Financial Interests, Personal, Other, Consulting Fees: AstraZeneca, TESARO/GSK, Pfizer, EISAI, Gilead, GenomicHealth; Financial Interests, Institutional, Other, Consulting Fees: VACIIBODY; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Clovis, GSK/

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