Jointly led by Professor Qin Shukui of Jinling Hospital of Nanjing University of Traditional Chinese Medicine and Professor Li Jin of Oriental Hospital Affiliated to Tongji University in Shanghai, and collaboratively conducted by 25 large research centers across the country, the "Registered Clinical Study of Nituzumab combined gemcitabine in the treatment of K-Ras wild-type locally advanced or metastatic pancreatic cancer (referred to as The Notable Study)" successfully reached the preset main research endpoint, and the relevant research papers stood out from more than 6300 submitted papers around the world. Selected as an oral presentation by the 2022 American Society of Clinical Oncology (ACSO) General Assembly. The study, sponsored by Baitai Biopharmaceutical Co., Ltd., is expected to solve the dilemma of the "king of cancer" pancreatic cancer today.
The picture shows that at the 2021 CSCO Annual Meeting, Professor Qin Shukui (middle), Professor Li Jin (right) and CCTV host Xu Li jointly participated in the "Innovation Leads the Future" live interview jointly launched by the People's Daily Health Client and CSCO. (Infographic)
Pancreatic cancer is a common clinical malignancy, the onset is hidden, rapid progression, early diagnosis is difficult, most patients have reached local advanced or distant metastasis when diagnosed, treatment is very tricky, the prognosis is poor, the survival time is very short, the treatment has been stagnant for many years, and it is urgent to explore new effective treatment methods and drugs.
Nituzumab is the first humanized monoclonal antibody developed and produced by Baitai Biopharmaceutical Company, a Sino-Cuban joint venture, which was approved by the State Food and Drug Administration for listing in China in 2008 for the treatment of nasopharyngeal carcinoma. In recent years, clinical research on the treatment of head and neck tumors, cervical cancer, esophageal cancer and pancreatic cancer is being further carried out, and clinical research is in full swing. The results of a previous phase II study of nituzumab combined with gemcitabine in Germany showed that the nittozumab plus gemcitabine group significantly prolonged the overall survival of the whole population in the combined group compared with gemcitabine monotherapy (OS was 8.6 months versus 6 months, p=0.03); for patients with high EGFR expression and KRAS wild type, the 1-year OS rates of EGFR high expression and monotherapy group were 36.4% and 8.3%, respectively (p= 0.045), while the two groups of K-Ras wild-type patients had 1-year OS rates of 53.5% and 15.8%, respectively (p=0.026).
The Notable study was a prospective, randomized controlled, double-blind, nationwide multicenter, registered Phase III clinical study in patients with locally advanced or metastatic pancreatic cancer of the wild type of the K-Ras gene. This is a clinical trial that screens enriched populations through molecular biomarkers, and adopts molecularly targeted drugs combined with chemotherapy drugs to achieve effective clinical trials, and obtains positive results, which is very valuable and has important clinical value and scientific significance!
This will be a breakthrough in the field of pancreatic cancer, which is expected to change the treatment status quo of pancreatic cancer and bring the dawn of life to patients with K-Ras wild-type pancreatic cancer. The specific results of the study will be officially announced at the ASCO Conference in June this year.
