From September 25 to 29, 2024, the 27th National Clinical Oncology Conference and the 2024 Academic Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) was held in Xiamen, where authoritative experts and scholars gathered to help China's anti-tumor cause flourish. In the pancreatic cancer session of the conference on the afternoon of the 28th, the team of Professor Li Qi and Professor Long Jiang of Shanghai General Hospital announced the preliminary data of a multi-center, single-arm Phase II clinical study of Utidelone combined with gemcitabine for the first-line treatment of unresectable advanced pancreatic cancer.
By the time of the conference presentation, 20 patients with advanced pancreatic cancer who were inoperable and unsuitable for local treatment had been enrolled in the study, and 11 had completed the first efficacy evaluation. Of these, 3 patients achieved partial response (PR) while 5 had stable disease (SD). The objective response rate (ORR) and disease control rate (DCR) were 27.27% and 72.72%, respectively; and the median overall survival (mOS) was 9.57 months. In terms of safety, most of the adverse events (AE) were grade 1 or 2, and only one patient had a grade 3-4 adverse event, granulocytopenia, which recovered after dose adjustment, indicating that the therapy was generally safe and controllable. The presentation also included a case report, in this study, a 72-year-old diagnosed with advanced pancreatic cancer with liver and bone metastasis underwent tumor evaluation after 3 cycles of Utidelone and gemcitabine combination treatment, compared with baseline imaging, the length of the pancreatic tail mass was reduced from 29mm to 17mm, and the efficacy was rated as PR. The patient had no AE during the treatment, the overall tolerance was good, and the overall survival reached 17.53 months at the present.
Pancreatic cancer is a highly malignant tumor, which is known as the "cancer king" because of its characteristics such as insidious early symptoms, difficulty in diagnosis, rapid progression, strong invasiveness, and poor prognosis [1]. According to statistics, the five-year survival rate of pancreatic cancer is only about 10%, which is far lower than other common cancers and has the lowest survival rate among all malignant tumors [2-3]. At present, there is no effective treatment for pancreatic cancer with proven efficacy, and gemcitabine-based combination regimen is still the most dominant clinical treatment. However, pancreatic cancer cells are easily resistant to gemcitabine, so the therapeutic effect is not ideal [4].
Utidelone is a national Class 1 anti-tumor innovative drug independently developed by Beijing Biostar. It has the characteristics and advantages of a broad anti-cancer spectrum, low hematological toxicity, breaking through the mechanism of multi-drug resistance, and penetrating the blood-brain barrier. The first indication of Utidelone Injection for advanced breast cancer was approved in March 2021, making it the only microtubule inhibitor with a novel molecular structure approved globally in the past 10 years. Based on the excellent broad-spectrum anti-cancer advantages of Utidelone, several indication expansion studies are actively underway. For example, in vivo and in vitro studies have revealed the potential of Utidelone in treating pancreatic cancer [5]: Utidelone can significantly inhibit the proliferation and colony-forming ability of pancreatic cancer cells and has good anti-tumor activity in pancreatic cancer models. When combined with gemcitabine, Utidelone can largely reduce the IC50 value of gemcitabine without weakening the killing effect on tumor cells, and the anti-tumor activity of the combination of the two is better than that of the traditional paclitaxel combined with gemcitabine.
The preliminary phase II clinical data released at this CSCO conference further proved that Utidelone combined with gemcitabine can bring good survival benefits and disease control rates for first-line treatment of patients with advanced pancreatic cancer, which is expected to improve the status of pancreatic cancer treatment desert and become a new treatment option for patients with pancreatic cancer.
About this study
This is a multicenter, single-arm Phase II clinical study, led by Shanghai General Hospital, 92 patients are expected to be enrolled, to evaluate the efficacy and safety of Utidelone combined with gemcitabine for the first-line treatment of unresectable advanced pancreatic cancer. The primary endpoint was OS, and secondary endpoints included ORR, DCR, safety, etc.
References
1. 杨宇,等. 胰腺癌药物治疗的选择. 临床合理用药. 2023;16(17):177-181.
2. 中国抗癌协会胰腺癌专业委员会. 中国抗癌协会胰腺癌整合诊治指南(精简版). 中国肿瘤临床. 2023,50(10):487-496.
3. Zheng R, et al. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent. 2022;2(1):1-9.
4. 刘成裕,等. 吉西他滨及其增效剂对胰腺癌细胞作用机制的研究进展. 现代药物与临床.
5. Zhou JY, et al. Utidelone combined with gemcitabine regimen inhibits pancreatic cancer cell proliferation in vitro and tumor formation in vivo by promoting early apoptosis. 2023 CCHIO.