Editor's Note: From July 5-7, 2024, the 2024 China Annual Clinical Oncology Advances Symposium (BOC) and Beast of ASCO® 2024 China (BOC/BOA) were grandly held in Guangzhou. In the field of breast cancer, this conference brought together important research from the Chinese breast cancer field in 2023 and highlighted key advancements from the American Society of Clinical Oncology (ASCO) Annual Meeting. As one of the contributors to the "Annual Advances in Clinical Oncology Research in China," Professor Biyun Wang from Fudan University Shanghai Cancer Center also detailed the ACE-Breast-02 study at this conference, showcasing the rigor and innovation of Chinese research. "Oncology Frontier" interviewed Professor Biyun Wang, and the compilation is presented below.

Oncology Frontier: CSCO YOUNG has done a lot of work in writing “Annual Advances in Clinical Oncology Research in China.” What notable innovative achievements have there been in the field of Chinese breast cancer over the past year? How should young experts fully utilize their intellect and talents in Chinese clinical oncology research?

Professor Biyun Wang: “Annual Advances in Clinical Oncology Research in China” is a long-term project led by the Chinese Society of Clinical Oncology (CSCO) and executed by our Young Committee. Since 2016, we have started preparing intensively around the submission deadline for the “National Natural Science Foundation.” In April, the Editorial Board meeting begins screening the research from the past year, with announcements made between June and July. By next year, this work will have continued for 10 years. During these 10 years, we have witnessed the rapid development of oncology in China, with Chinese scholars gradually improving in quantity, quality, depth, and breadth of articles. In my view, this work is a long-term project that we can be proud of. In 2023, we had several representative studies in the field of Chinese breast cancer: The first is the TORCHLIGHT study led by Professor Jiang Zefei of the PLA General Hospital, which explores the first-line application of immunotherapy for triple-negative breast cancer and was reported at the 2023 ASCO Annual Meeting. The full study was published in “Nature Medicine” (IF=58.7) in 2024, and will be compiled in the annual progress report next year. The second is the DAWNA-2 study led by Academician Xu Binghe of the Chinese Academy of Medical Sciences Cancer Hospital, which used Darsetuli as a first-line treatment for HR+/HER2-advanced breast cancer patients. The study was published in “Lancet Oncology” (IF=51.1). The third is also led by Academician Xu Binghe’s PHILA study, exploring the results of small molecule tyrosine kinase inhibition (TKI) Pyritinib as a first-line treatment for HER2-positive breast cancer, which was published in the high-impact journal “The British Medical Journal” (IF=105.7). The fourth is the further exploration of the “Fudan Classification” by Professor Shao’s team at Fudan University Cancer Hospital. Based on the previous classification of triple-negative breast cancer into “Fudan Four Types,” this time Luminal subtypes were differentiated in detail, and published in “Nature Genetics” (IF=31.7). I think the above studies and the publication of their articles provide high-level evidence-based medicine for clinical practice. We young doctors should learn from the work and spirit of our predecessors, actively carry out multicenter and multidisciplinary collaboration, encourage the integration of clinical and scientific research, and continue to grow and progress. In addition, the Beijing Xisk Clinical Cancer Research Foundation also has special projects such as “Chaoyang Cancer Research Fund” for young doctors, encouraging young scholars to innovate and explore boldly.

Oncology Frontier: You introduced the ACE-Breast-02 study at this conference. Please share the results of this study.

Professor Biyun Wang: I reported the ACE-Breast-02 study at this BOC/BOA conference. The study was orally presented at the 2024 ASCO Annual Meeting by Professor Hu Xichun of Fudan University Affiliated Cancer Hospital. The study used a new antibody-drug conjugate (ADC) called ARX788, which attaches a cytotoxic payload to the HER2 antibody heavy chain using non-natural amino acids, making the connection very stable. Although the drug-antibody ratio (DAR) is only 2, due to its stable structure, free toxin is almost undetectable in the blood. Previous phase I studies reported good efficacy of ARX788. Building on this, we further conducted phase II and III multicenter clinical studies. Because the ACE-Breast-02 study was designed earlier, ARX788 was compared to Lapatinib combined with Capecitabine in HER2-positive breast cancer patients for second-line and above treatments. The study achieved the primary endpoint of superior efficacy, with a median progression-free survival (mPFS) assessed independently by the blind review center of 11.33 months vs. 8.25 months (HR 0.64, P=0.0006). In terms of safety, the main adverse event of ARX788 was hepatotoxicity, with an incidence rate of approximately 70%, of which ≥3 grade was only 1.4%, in addition to eye toxicity and pulmonary toxicity (interstitial lung disease) also need to be noted. At present, we have achieved good control of ARX788’s adverse reactions through multidisciplinary cooperation. I think this study has been quite successful. ARX788 is being developed synchronously in China and abroad. When foreign countries encountered difficulties and suspended related research, they resumed research after we reported the results of this study and demonstrated excellent toxicity control through multidisciplinary cooperation. Therefore, Chinese scholars have set a good example for drug development. In our ADC development, we focus on balancing efficacy and adverse reactions, effectively preventing and handling related adverse reactions.

Professor Biyun Wang

Department of Oncology Fudan University Affiliated Cancer Hospital Director, Breast and Genitourinary Tumor Specialty Chief Physician, Master’s Tutor Director, Chinese Society of Clinical Oncology (CSCO) Chairman, CSCO Young Committee Executive Committee Member and Secretary-General, CSCO Patient Education Expert Committee Member, CSCO Breast Cancer Expert Committee Deputy Director and Secretary-General, Cancer Rehabilitation and Palliative Therapy Special Committee, Shanghai Anti-Cancer Association CRPC Standing Committee Member, Shanghai Anti-Cancer Association Breast Cancer Professional Committee Executive Director, Youth Council, Shanghai Anti-Cancer Association