An interview with:

https://www.audiomedica.com/wp-content/2025/11/251019-Erwei-Song-ESMO-2025-PRODUCTION-MASTER.mp3, Director of Health Science Center, President, Sun Yat-sen Memorial Hospital, Guangzhou (SYSU), Guangzhou, China.

BERLIN, Germany—The open-label HORIZON-Breast01 phase-three study has reported early data showing that, for previously treated patients with advanced or metastatic breast cancer, progression-free survival improved from a median of 8.3 months with pyrotinib plus capecitabine standard of care to 30.6 months among patients in the experimental arm who received monotherapy with the new antibody drug conjugate (ADC) trastuzumab resetecan. Furthermore, the ADC had a favorable safety profile with low occurrence of interstitial lung disease (ILD).

Findings were reported at the 2025 Annual Congress of the European Society for Medical Oncology by Erwei Song MD PhD, Director of the Health Science Center, President, Sun Yat-sen Memorial Hospital, Guangzhou (SYSU), in Guangzhou, China. After his talk at the conference, Professor Song discussed the findings with Audio Journal of Oncology reporter Peter Goodwin:

Audio Journal of Oncology: Erwei Song MD PhD

IN: “[GOODWIN] I am at ……  OUT:  …….of Oncology, I’m Peter Goodwin. 7:42secs

ESMO ABSTRACT LBA19:

“SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): A multicenter, open-label, randomized, phase III study (HORIZON-Breast01)”

Speaker: Erwei Song (Guangzhou, China)

Authors:

Erwei Song (Guangzhou, China) Herui Yao (Guangzhou, China) Huiping Li (Beijing, China) Yongmei Yin (Nanjing, China) Qing Yuan Zhang (Harbin, China) Shusen Wang (Guangzhou, China) Quchang Ouyang (Changsha, China) Tao Sun (Shenyang, Liaoning, China) Xiaojia Wang (Hangzhou, China) Weimin Xie (Nanning, China) Biyun Wang (Shanghai, China) Wei Li (Changchun, China) Min Yan (Zhengzhou, China) Cuizhi Geng (Shijiazhuang, China) Yuan Peng (Beijing, China) Yaping Yang (Guangzhou, China) Fangli Dong (Shanghai, China) Ying Zhang (Shanghai, China) Lin Cheng (Shanghai, China) Xiaoyu Zhu (Shanghai, China)

Background

SHR-A1811, a HER2-targeted antibody-drug conjugate, proved substantial single agent antitumor activity in heavily pretreated solid tumors as shown in a global phase 1 trial (J Clin Oncol. 2024). Here, we first report the interim analysis of SHR-A1811 versus pyrotinib plus capecitabine in HER2+ advanced/metastatic BC from the pivotal phase 3 HORIZON-Breast01 study.

Methods

Taxane- and trastuzumab-pretreated patients (pts) with HER2+ advanced/metastatic BC were randomized (1:1) to receive intravenous SHR-A1811 or oral pyrotinib plus capecitabine. The primary endpoint was PFS by blinded independent central review (BICR).

Results

As of Jun 30, 2025, 287 pts were randomized (SHR-A1811, n=142; pyrotinib plus capecitabine, n=145; IHC 3+: 76.1% vs. 71.7%; HR+: 47.9% vs. 47.6%; median lines of prior systemic treatments: 1 vs.1; prior pertuzumab: 71.8% vs. 72.4%), with median follow-up of 15.9 months (95% CI 14.6–17.1) for SHR-A1811, and 15.3 months (95% CI 14.3–16.6) for pyrotinib plus capecitabine. The PFS by BICR was significantly improved in the SHR-A1811 group than in the pyrotinib plus capecitabine group (30.6 months vs. 8.3 months; HR 0.22 [95% CI 0.15–0.34]; p0.0001; table). Although the median OS was not yet reached, SHR-A1811 showed a clear OS benefit trend. Median treatment duration was 19.5 months (95% CI 17.3–NR) with SHR-A1811, 7.1 months (95% CI 5.6–9.2) with pyrotinib, and 7.5 months (95% CI 5.7–9.6) with capecitabine. Similar rates of TRAEs were observed. Interstitial lung disease (ILD) occurred only in 4 pts (2.8%) receiving SHR-A1811 (grade 1/2: 3 [2.1%]; grade 3: 1 [0.7%]).

Conclusions

SHR-A1811 exhibited significant PFS benefit and strong trend in OS benefit versus pyrotinib plus capecitabine in the second-line therapy in HER2+ advanced/metastatic BC, with favorable safety profile of low ILD occurrence.

Clinical trial identification

NCT05424835.

Legal entity responsible for the study

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Funding

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Disclosure

Dong, Y. Zhang, L. Cheng, X. Zhu: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Episode ID: 1000736754766

GUID: fa632151-2998-5473-84bc-faa04b90ec4b

Release Date: 14/11/2025, 20:36:19