A “Chinese Approach” to Immunotherapy for Triple-Negative Breast Cancer

Recently, at the 2024 San Antonio Breast Cancer Conference, Professor Shao Zhimin’s team at Fudan University Shanghai Cancer Center released a key clinical phase III research result that changes the neoadjuvant treatment model for triple-negative breast cancer.

This study combined the use of China's original new immunotherapy drug camrelizumab (a PD-1 monoclonal antibody) on the basis of conventional anthracycline, taxane, platinum, and cyclophosphamide chemotherapy to increase the pathological complete response rate of neoadjuvant treatment for triple-negative breast cancer by 12.1% (from 44.7% to 56.8%), which is significantly better than currently commonly used chemotherapy regimens.

The study was published in the Journal of the American Medical Association (JAMA) at the same time. This is also the first time in the 141 years since JAMA was founded that original new drug research on breast cancer based on the Chinese population has been published, providing strong evidence for the "Chinese approach" to neoadjuvant immunotherapy for triple-negative breast cancer.

The most “aggressive” breast cancer treatment bottleneck

Triple-negative breast cancer accounts for about 10%-20% of all new breast cancers. The disease has a high risk of recurrence and is highly invasive. Systemic treatment mainly relies on chemotherapy. The efficacy is worse than other types of breast cancer, so it is often called the most "aggressive" breast cancer.

Currently, the standard neoadjuvant treatment regimen for triple-negative breast cancer is taxane, anthracycline, and cyclophosphamide-based chemotherapy. Shao Zhimin, director of the General Surgery Department and Breast Surgery Department of the Cancer Hospital, said, "We are considering combining camrelizumab with the neoadjuvant chemotherapy regimen for triple-negative breast cancer to explore opportunities to improve patient outcomes."

In order to further explore whether camrelizumab can enhance the efficacy of neoadjuvant chemotherapy in the Chinese population, especially in high-risk triple-negative breast cancer with more lymph node metastases, Shao Zhimin, as the chief investigator, led a total of 40 clinical centers in China to conduct a clinical study called "CamRelief".

Contribute “Chinese solution” to treatment

According to the study design, the "CamRelief" study included a total of 441 patients with early or locally advanced triple-negative breast cancer who received neoadjuvant camrelizumab or placebo combined with chemotherapy before surgery and continued to receive camrelizumab or placebo for up to one year after surgery.

The study showed that after a median follow-up of 14.4 months, patients who added camrelizumab to the standard chemotherapy regimen had a pathological complete response rate of 56.8%, which was significantly better than the 44.7% in the control group. The absolute benefit was as high as 12.1%, meeting the preset statistical test standards.

Subgroup analysis showed that the therapeutic effectiveness of the camrelizumab chemotherapy group was higher than that of the placebo chemotherapy group. Moreover, the safety of the additional use of camrelizumab was controllable, and no uncontrollable adverse reactions were observed that were different from previous reports.

It is worth noting that the patients enrolled in this study were all Chinese, and 70.5% of the patients had positive lymph nodes, and the proportion of stage III patients was 35.8%, which is much higher than that of previous large-scale studies (21.2% in the IMpassion031 study and 24.9% in the KEYNOTE-522 study), which is of great significance to such clinical high-risk groups.

"The addition of camrelizumab to traditional chemotherapy increased the efficacy of neoadjuvant therapy in patients by more than 10%, and benefits were observed in all subgroups." Shao Zhimin said, "While significantly improving the neoadjuvant efficacy of triple-negative breast cancer patients, the safety of this treatment regimen is controllable, and it is expected to truly change the clinical practice of neoadjuvant therapy."

Integration of medical enterprises breeds new achievements

It is understood that the "CamRelief" study is another landmark achievement of the integrated development of production and medicine by the breast surgery team of Fudan University Shanghai Cancer Center following FUTUER-SUPER (published in The Lancet-Oncology Volume) in January 2024 and BCTOP-A-01 (published in the British Medical Journal) in October 2024.

Ten years ago, the team led by Shao Zhimin began to work on solving the problem of precision treatment of triple-negative breast cancer, establishing the world's largest multi-omics cohort of triple-negative breast cancer, drawing the world's largest genetic map of triple-negative breast cancer, and pioneeringly proposed a "precision treatment strategy for triple-negative breast cancer based on molecular classification", which tripled the efficacy of this most "toxic" breast cancer and produced a number of internationally influential research results and patent transformation of important scientific research results.

"The birth of this important result is inseparable from the strong support of pharmaceutical companies and 40 clinical centers across the country, which provides a good example for the subsequent integrated research model of medical companies." Shao Zhimin said, "This year, the cancer hospital took the lead in establishing the Breast Cancer Precision Treatment Collaboration Group (BCTOP), aiming to collaboratively carry out clinical research on precision treatment of breast cancer in multiple centers and build a translational research platform for breast cancer with Chinese characteristics."

Global Conference issues “China’s voice”

The breast cancer clinical research team of Fudan University Shanghai Cancer Center is a "frequent visitor" to the San Antonio Breast Cancer Conference. It has shared "Chinese experience" and introduced "Chinese solutions" at the world's top breast cancer conference six times. At this conference, Professor Shao Zhimin and Professor Li Junjie, deputy director of the Breast Surgery Department, gave oral reports at the plenary meeting on the two "China Plans" hosted by the team. Shao Zhimin was also invited to serve as the host of the conference.

In addition to oral reports, experts and scholars such as Professor Wu Jiong, Executive Vice President of Fudan University Shanghai Cancer Center, Professor Hu Xichun, Professor Zhang Jian, Professor Wang Biyun, Professor Liu Xiyu, and Wang Zehao from the Department of Medical Oncology completed a total of 8 Poster Spotlight reports. These reports cover cutting-edge research results in many aspects of breast cancer treatment, including new drug research and development, exploration of treatment options, and immunotherapy, etc., demonstrating the innovative development and leading position of "Fudan Oncology" in the field of global basic and clinical research on breast cancer.