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May 24, 2026Open Access

469P Clinical outcomes and safety of sacituzumab govitecan in Chinese patients with metastatic HER2-negative breast cancer: A real-world study

Key Points

This study aims to evaluate the effectiveness and safety of sacituzumab govitecan in Chinese patients with metastatic HER2-negative breast cancer.
Data collection from 103 patients with HER2-negative metastatic breast cancer between Jun. 2023 and Dec. 2025.
Evaluated overall response rate, disease control rate, and median progression-free survival.
Analyzed adverse events, including hematological and non-hematological types.
Overall response rate was 26.2% and disease control rate was 88.3%, with median progression-free survival of 5.1 months (95%CI 4.1-6.5).
In mTNBC patients, the median progression-free survival was 5.1 months, highlighting varying responses based on treatment lines.
Reported hematological adverse events in 47.6% of patients, with anemia, leukopenia, and neutropenia as the most common.

Abstract

Background: Sacituzumab Govitecan (SG) is a Trop-2 ADC that has improved efficacy in patients (pts) with metastatic breast cancer (mBC).The aim of study conducted at 5 Chinese centers was to evaluate the effectiveness and safety of SG in a real-world setting. Methods:In this study, we collected the data of patients with HER2-negative mBC treated with SG from Jun. 2023 until Dec. 2025.Results: 103 pts were identified.Median follow-up was 11.0 months.Median age was 54 years.71 (68.9%) pts had visceral metastases, with 26 (25.2%) pts having brain metastasis at SG initiation.19 (18.4%) pts received prior ADC therapy.77 (74.8%) pts received SG as monotherapy, while 26 (25.2%) pts receiving SG combinations.Among all pts in which response was assessed, ORR was 26.2%, DCR was 88.3%, and mPFS was 5.1 months (95%CI 4.1-6.5).In mTNBC pts (n=68), median treatment line of SG was 3 (95%CI 1-15).ORR was 26.5%, DCR was 86.8%; mPFS was 5.1 months (95%CI 4.0-7.1). 10 (14.7%) and 23 (33.8%) pts received SG as 1 st and 2 nd treatment line has a mPFS of 8.1 months (95%CI 7.1-NA) and 5.1 months (95%CI 3.8-NA), respectively.20 (29.4%) pts received prior ICI which had a mPFS of 5.9 months (95%CI 4.0-NA); 11 (16.2%)pts received prior ADC with a mPFS of 5.9 months (95%CI 2.0-NA).In 35 pts with HR+, HER2-mBC, ORR was 25.7%, DCR was 91.4%; mPFS was 4.7 months (95%CI 3.9-8.2). 19 (54.3%) pts with HER2 IHC 0 had a mPFS of 5.0 months (95%CI 4.0-8.4),and 15 (42.9%) pts with HER2 low had a mPFS of 4.0 months (95%CI 3.6-NA).mPFS for 26 (74.3%) pts with prior CDK4/6i treatment was 4.6 months (95%CI 3.7-8.4).8 (22.9%) pts who received prior ADC had a mPFS of 4.0 months (95%CI 3.7-NA).Hematological AEs of 49 (47.6%)pts were collected.The most common ones: anemia (69.4%), leukopenia (67.3%) and neutropenia (61.2%).Grade 3-4 AEs occurred in 16 (32.7%)pts, with lymphocytopenia (16.3%) and neutropenia (16.3%) being the highest.Non-hematological AEs were collected in 46 (44.7%) pts.The most common AEs were nausea (71.7%) and fatigue (67.4%).Grade 3 AEs occurred in 4 (8.7%)pts with fatigue (6.5%) followed by nausea (4.3%), vomiting (4.3%) and diarrhea (2.2%). Conclusions:Our study describes the real-world experience of SG in Chinese patients with mBC.

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