Short-term results from the CamRelief phase 3 trial show that neoadjuvant camrelizumab (AiRuiKa) plus chemotherapy improves the rate of pathological complete response (pCR) when compared with chemotherapy alone in early or locally advanced triple-negative breast cancer (TNBC). The findings, (Abstract GS3-06) presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) and simultaneously published in JAMA, represent growing progress in treating this aggressive and difficult-to-treat disease.
“Now, this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning,” said Giampaolo Bianchini, MD, a discussant for the SABCS session and associate professor at the Vita-Salute San Raffaele University in Milan, Italy, quoting Winston Churchill after the Second Battle of El Alamein in 1942.
Approximately 15% of all breast cancers are TNBC, which has higher recurrence and worse survival rates than other forms of the cancer but is also the most immunogenic of all breast cancer subtypes. Camrelizumab is approved in China for treating Hodgkin lymphoma and as a second-line treatment for hepatocellular carcinoma.
“Camrelizumab, which is an anti-PD-1 monoclonal antibody, has demonstrated robust antitumor activity and favorable tolerability in phase 2 trials in early-stage and advanced triple-negative breast cancer,” said Zhi-Ming Shao, MD, lead author of the study and director of the Fudan University Cancer Institute in Shanghai, China.
The trial randomly assigned 222 patients to receive camrelizumab and another 219 to be given a placebo across 40 hospitals in China between November 25, 2020, and May 12, 2023. Each group also received chemotherapy every two weeks. The chemotherapy included nab-paclitaxel and carboplatin for the first 16 weeks, followed by epirubicin and cyclophosphamide every two weeks for eight weeks. The primary endpoint was pCR, which was defined as having no invasive tumor in breast and lymph nodes. The median age of the patients was 48 years.
At a data cutoff of September 30, 2023, and a median follow-up of 14.4 months, the pCR was 56.8% with camrelizumab and 44.7% in the placebo group. For high-risk stage III TNBC, the pCR was 49.4% in the camrelizumab group and 38.0% in the placebo group. For node-positive TNBC, the pCR was 57.8% and 42.7%, respectively.
In the neoadjuvant phase, grade 3 or higher adverse events (AEs) occurred in 89.2% of patients in the camrelizumab group and 83.1% in the placebo group. Serious AEs were seen in 34.7% of patients in the camrelizumab group and 22.8% of patients in the placebo group. Fatal AEs occurred in two patients in the camrelizumab group and none in the placebo group. The most common serious AEs were decreased neutrophil count (9.5% and 6.4%, respectively), decreased platelet count (7.2% vs 4.6%), and decreased white blood cell count (6.8% vs 3.7%).
“Our data supports camrelizumab plus chemotherapy as a potential new therapeutic option for treating early or locally advanced triple-negative breast cancer,” said Dr. Shao.
Dr. Bianchini cautioned that no evidence suggests that pCR is a surrogate for long-term benefit. With that in mind, he said, the results are not practice-changing at this time, and “demonstration of long-term benefit is needed.”
Dr. Shao and Dr. Bianchini noted that the study’s limitations include being conducted solely within the Chinese population. Follow-up is ongoing in the trial, and long-term data will be presented in the future.
Jiangsu Hengrui Pharmaceuticals sponsored this study.
Dr. Shao reported no relevant relationships.
Dr. Bianchini reported relationships with various companies.
