Clinical study data on nimotuzumab for pancreatic cancer released, the results are encouraging

Pancreatic cancer is a highly malignant digestive system tumor. According to GLOBOCAN data in 2020, there were approximately 496,000 new cases of pancreatic cancer and approximately 466,000 new deaths worldwide. The mortality rate of pancreatic cancer in my country has been increasing year by year. The main reason for the high mortality rate of pancreatic cancer is that there are no specific symptoms in the early stages of pancreatic cancer, and there is a lack of highly sensitive diagnostic methods and effective treatment methods. At present, the treatment method recommended by major global guidelines is still mainly chemotherapy. There is no effective treatment for patients who have failed second-line chemotherapy or above, and there is a lack of effective drugs in clinical practice.

On June 4, 2022, Biotech held a "Press Conference on Major Research Results in Targeted Therapy for Pancreatic Cancer" and announced the data of "Clinical Study of Nimotuzumab Combined with Gemcitabine Versus Gemcitabine for the Treatment of KRAS Wild-Type Locally Advanced or Metastatic Pancreatic Cancer". This is a prospective, randomized, controlled, double-blind, multicenter, Phase III registration study, co-led by President Qin Shukui of Jinling Hospital of Nanjing University of Chinese Medicine and Professor Li Jin of Shanghai Tongji University Affiliated Oriental Hospital, with the participation of 25 centers across the country. The research results were selected for oral presentations and breakthrough studies (LBA) at the 2022 American Society of Clinical Oncology Annual Meeting (ASCO), and were selected as Best of ASCO. This year, ASCO selected a total of 5,198 abstracts, of which only 37 were breakthrough studies. The selection of Notable studies in LBA represents that my country's clinical research has reached the world's leading level. In the early morning of June 4, President Qin Shukui reported the research results to the ASCO conference online on behalf of all researchers. The conference specially invited German experts to comment on the research for 12 minutes, and the experts at the conference highly recognized the research.

Figure 1: Dr. Qin Shukui reported the results of the Nimotuzumab study at the ASCO conference on June 4

Figure 2: Professor Li Jin presided over the Nimotuzumab press conference

Figure 3: Dr. Qin Shukui reported the research data of Nimotuzumab at the press conference

The Notable study trial group received nimotuzumab (400 mg, once a week, until disease progression or intolerance) gemcitabine (1000 mg/m2, days 1, 8, and 15, every 4 weeks, until disease progression or intolerance), and the control group received placebo gemcitabine. The study found that nimotuzumab combined with gemcitabine significantly prolonged overall survival compared with placebo combined with gemcitabine, with mOS of 10.9 months and 8.5 months in the two groups, 1-year survival rates of 43.6% and 26.8%, and 3-year survival rates of 13.9% and 2.7%, respectively, P=0.024; nimotuzumab significantly prolonged progression-free survival, with mPFS of 4.2 months and 3.6 months in the trial group and control group, respectively, P=0.013. Nimotuzumab has good safety, and most adverse reactions are grade 1-2, with a very low incidence of grade 3, and no grade 4-5 adverse reactions.

Figure 4: Dean Qin Shukui and Professor Li Jin were interviewed by the media

After the data release conference, President Qin Shukui and Professor Li Jin accepted online media interviews. President Qin Shukui said that the Notable study not only provides a new treatment for Kras wild-type pancreatic cancer, but also inspires clinical research exploration, which has great scientific significance and clinical value. In the future, based on this study, the population can be expanded to further prove the efficacy and safety. The German Phase II study has preliminarily proved that patients with high EGFR expression benefit more from nimotuzumab treatment, and EGFR high-standard expression is expected to become a new advantage population for nimotuzumab.

Professor Li Jin emphasized that there is still a lack of effective therapeutic drugs for pancreatic cancer. In the past, pancreatic cancer treatment was mainly based on gemcitabine. Even though the three-drug combination regimen failed to fundamentally solve the short survival benefit of pancreatic cancer patients, OS was only extended to 6-8 months. The Notable study obtained OS and PFS extensions, and OS was extended to about 1 year, which is exciting. In the future, Nimotuzumab can try more combined drugs, such as immune checkpoint inhibitors, anti-angiogenic drugs, etc. Nimotuzumab has a significant effect in treating pancreatic cancer, and Nimotuzumab combined with chemotherapy is expected to become a new first-line standard treatment for locally advanced or advanced pancreatic cancer.