Editor's Note: At the 2024 San Antonio Breast Cancer Symposium (SABCS), one of the world’s most prestigious events in breast cancer research, Chinese scholars once again demonstrated their exceptional expertise and innovative spirit in the field of breast cancer treatment. A groundbreaking study led by Dr. Nanlin Li and his team from Xijing Hospital of the Air Force Medical University brings renewed hope to breast cancer patients in China and offers fresh strategies to the global breast cancer research community. This study focuses on precision therapy for breast cancer, exploring the efficacy and safety of envafolimab combined with pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2-positive breast cancer. Below, we provide a detailed introduction to the research.

• Dr. Nanlin Li：HER2 is one of the most common oncogenes driving breast cancer. As a tumor-associated antigen, it is overexpressed in some breast cancers and serves as a critical biomarker and prognostic factor. HER2-positive breast cancer is known for its aggressive nature and high invasiveness, making it a significant clinical challenge. Neoadjuvant therapy (NAT) offers more opportunities for breast-conserving treatment in HER2-positive patients. It also allows clinicians to assess a patient’s sensitivity to drugs early, thereby improving long-term outcomes.
• Studies have shown that achieving pathological complete response (pCR) after NAT significantly enhances disease-free survival (DFS) in breast cancer patients. pCR has emerged as a reliable predictor of overall survival (OS) and DFS. The inclusion of anti-HER2 targeted therapies in NAT protocols has notably improved the pCR rates and prognoses of patients with HER2-positive breast cancer.
• Currently, approved anti-HER2 drugs for NAT, such as trastuzumab ± pertuzumab, address certain treatment needs but often fall short of achieving individualized and precise therapy goals. Envafolimab, China’s first independently developed anti-HER2 monoclonal antibody, was approved by the National Medical Products Administration (NMPA) in June 2020 for use in combination with chemotherapy for HER2-positive metastatic breast cancer. This drug provides a novel treatment option for Chinese patients with HER2-positive breast cancer.
• Envafolimab is a recombinant humanized monoclonal antibody whose Fab fragment matches that of trastuzumab. Through Fc modification and production process optimization, envafolimab enhances antibody-dependent cellular cytotoxicity (ADCC). It blocks the HER2 pathway, directly suppressing tumor cell proliferation and growth, while inducing ADCC to help the immune system recognize and destroy cancer cells.
• Pyrotinib, another innovative drug independently developed in China, is a new-generation oral tyrosine kinase inhibitor (TKI) specifically targeting HER2. It is primarily used for HER2-positive recurrent or metastatic breast cancer, as well as in combination with trastuzumab and docetaxel for early or locally advanced HER2-positive breast cancer in NAT. By inhibiting the HER2 signaling pathway, pyrotinib significantly improves therapeutic outcomes.
• Combining small and large molecule therapies targeting HER2 in NAT protocols has shown remarkable efficacy, earning endorsements in clinical guidelines and inclusion in insurance coverage. As China’s “new dual targets” for anti-HER2 therapy, envafolimab and pyrotinib have already demonstrated promising results in multiple phase II clinical trials. The ongoing phase III trials are eagerly anticipated to deliver even better outcomes and benefit more breast cancer patients.

About Dr. Nanlin Li

• Deputy Chief Physician and Associate Professor, Xijing Hospital, Air Force Medical University, Department of Thyroid, Breast, and Vascular Surgery.
• Doctor of Medicine and Master’s Supervisor.
• Vice Chair, Breast Tumor Committee, Chinese Primary Health Care Foundation.
• Standing Member, Breast Cancer Committee, Chinese Anti-Cancer Association.
• Member, Breast Cancer Expert Committee, Chinese Society of Clinical Oncology (CSCO).
• Standing Member, Patient Education Expert Committee, CSCO.
• Standing Member, Breast Cancer Committee, Shaanxi Provincial Anti-Cancer Association.
• Standing Member, Anti-Cancer Drug Committee, Shaanxi Provincial Anti-Cancer Association.
• Member, Comprehensive Cancer Treatment Committee, Shaanxi Provincial Anti-Cancer Association.
• Health Science Expert, Shaanxi Province.

A graduate of the Fourth Military Medical University in 1997, Professor Li has dedicated his career to general surgery, specializing in the diagnosis and standardized treatment of breast and thyroid cancers. He is the recipient of numerous research grants, including several from the National Natural Science Foundation of China and provincial-level funds. Professor Li was recognized as a “Top Educator” in 2008 and was among the first batch of “Young Talents Support Program” awardees in 2009. He has been awarded third-class personal merit once and has published over 30 SCI-indexed papers as the first or corresponding author, along with 13 national patents. He has authored or translated eight academic works.