Senologie - Zeitschrift für Mammadiagnostik und -therapie 2024; 21(02): e22
DOI: 10.1055/s-0044-1786114
Abstracts

Efficacy and safety analyses by prior lines of chemotherapy from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients with HR+/HER2- metastatic breast cancer (mBC)

Authors

  • F. Marmé

    1   Department of Obstetrics and Gynaecology, Universitatsmedizin Mannheim, Mannheim, Deutschland

  • J. Cortés

    2   Department of Medicine, Oncology Department, International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain/Medica Scientia Innovation Research (MedSIR), Barcelona, Spanien

  • P. Schmid

    3   Medical Oncology, Barts Health NHS Trust, London, Vereinigtes Königreich

  • H. S. Rugo

    4   Department of Medicine, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, Vereinigte Staaten

  • S. M. Tolaney

    5   Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Vereinigte Staaten

  • W. Verret

    6   Department of Clinical Development, Gilead Sciences Inc., Foster City, Vereinigte Staaten

  • T. Valdez

    7   Department of Patient Safety, Gilead Sciences Inc., Foster City, Vereinigte Staaten

  • Y. Huo

    8   Department of Biostatistics, Gilead Sciences Inc., Foster City, Vereinigte Staaten

  • A. Bardia

    9   Medical Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Vereinigte Staaten
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Background: SG is a Trop-2–directed antibody-drug-conjugate approved for pretreated HR+/HER2- (IHC0, 1+, 2+/ISH-) mBC. In TROPiCS-02, SG showed statistically significant improvement in PFS (HR 0.66; 95%-CI 0.53-0.83) and OS (HR 0.79; 95%-CI 0.65-0.96) vs TPC with manageable safety in pretreated HR+/HER2- mBC (Rugo et al. ESMO 2022). Outcomes worsen with multiple prior lines of chemotherapy (pLoT). We present a TROPiCS-02 post-hoc-analysis of SG vs TPC by pLoT.

Methods: Patients with HR+/HER2- mBC and≥1 endocrine, taxane, and CDK4/6i, and 2-4 pLoT for mBC, were randomized to SG (10mg/kg IV Days 1 and 8, Q3W) or TPC. Primary endpoint was PFS; secondary endpoints OS, ORR, CBR, and safety. This analysis compares 2 vs≥3pLoT.

Results: 543 patients received SG (n=272; 113 (42%) had 2pLoT, 159 (58%) had≥3pLoT) and TPC (n=271; 120 (44%) had 2pLoT, 151 (56%) had≥3pLoT). Baseline characteristics were similar. PFS and OS were improved with SG irrespective of pLoT (HR=0.61 and 0.82 in patients with 2pLoT and 0.72 and 0.78 in patients with≥3pLoT, respectively). CBR was improved with SG in patients with 2 and≥3pLoT (2pLoT: 41% vs 25%;≥3pLoT: 29% vs 20%), ORR was improved in patients with 2pLoT (30% vs 16%), and grade 3/4 TEAEs were similar (2pLoT: 71% vs 53%;≥3pLoT: 72% vs 66%).

Conclusions: Regardless of number of pLoT, SG improved efficacy vs TPC in patients with HR+/HER2- mBC, with manageable safety. Findings are consistent with the ITT population, demonstrating the potential for patients to benefit from SG in earlier pLoT.



Publication History

Article published online:
03 May 2024

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