Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial

Binghe Xu; Shusen Wang; Min Yan; Joohyuk Sohn; Wei Li; Jinhai Tang; Xiaojia Wang; Ying Wang; Seock-Ah Im; Dongdong Jiang; Theresa Valdez; Anandaroop Dasgupta; Yiran Zhang; Yilin Yan; Kimberly M Komatsubara; Wei-Pang Chung; Fei Ma; Ming-Shen Dai

doi:10.1038/s41591-024-03269-z

Sacituzumab govitecan in HR⁺HER2^- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial

Nat Med. 2024 Oct 1. doi: 10.1038/s41591-024-03269-z. Online ahead of print.

Authors

Binghe Xu¹, Shusen Wang², Min Yan³, Joohyuk Sohn⁴, Wei Li⁵, Jinhai Tang⁶, Xiaojia Wang⁷, Ying Wang⁸, Seock-Ah Im⁹, Dongdong Jiang¹⁰, Theresa Valdez¹¹, Anandaroop Dasgupta¹¹, Yiran Zhang¹¹, Yilin Yan¹¹, Kimberly M Komatsubara¹¹, Wei-Pang Chung¹², Fei Ma¹³, Ming-Shen Dai¹⁴

Affiliations

¹ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [email protected].
² Sun Yat-sen University Cancer Center, Guangzhou, China.
³ Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
⁴ Yonsei Cancer Center, Seoul, Republic of Korea.
⁵ The First Hospital of Jilin University, Changchun, China.
⁶ The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
⁷ Zhejiang Cancer Hospital, Hangzhou, China.
⁸ Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
⁹ Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.
¹⁰ Gilead Sciences Inc., Shanghai, China.
¹¹ Gilead Sciences Inc., Foster City, CA, USA.
¹² National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
¹³ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
¹⁴ Tri-Service General Hospital, Taipei, Taiwan.

PMID: 39354196
DOI: 10.1038/s41591-024-03269-z

Abstract

Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR⁺HER2^-) metastatic breast cancer (mBC) in the global TROPiCS-02 study. TROPiCS-02 enrolled few Asian patients. Here we report results of SG in Asian patients with HR⁺HER2^- mBC from the EVER-132-002 study. Patients were randomized to SG (n = 166) or chemotherapy (n = 165). The primary endpoint was met: PFS was improved with SG versus chemotherapy (hazard ratio of 0.67, 95% confidence interval 0.52-0.87; P = 0.0028; median 4.3 versus 4.2 months). OS also improved with SG versus chemotherapy (hazard ratio of 0.64, 95% confidence interval 0.47-0.88; P = 0.0061; median 21.0 versus 15.3 months). The most common grade ≥3 treatment-emergent adverse events were neutropenia, leukopenia and anemia. SG demonstrated significant and clinically meaningful improvement in PFS and OS versus chemotherapy, with a manageable safety profile consistent with prior studies. SG represents a promising treatment option for Asian patients with HR⁺HER2^- mBC (ClinicalTrials.gov identifier no. NCT04639986 ).

Associated data

ClinicalTrials.gov/NCT04639986