Bringing new treatments to gastric cancer patients, Shanghai’s original new drug research was published in "Nature Medicine"
At the recent annual meeting of the American Clinical Oncology Conference, the results of the Phase III clinical study of fruquintinib and paclitaxel combination therapy, a Shanghai-original new drug developed by Chi-Med Medicine, for the second-line treatment of advanced gastric cancer were released in the form of an "oral report." This report was also published in the top international medical journal "Nature Medicine". It has also appeared in the American Clinical Oncology Conference and "Nature Medicine", which shows the recognition of China's original new drug research by authoritative international academic institutions and industry experts.
Gastric cancer is the fifth most common malignant tumor worldwide. China is one of the countries with a high incidence of gastric cancer. In 2022, there will be about 359,000 new cases of gastric cancer and about 260,000 deaths. The disease burden is severe. Because the symptoms of early gastric cancer are not obvious, most gastric cancers are already in the intermediate and advanced stages when first diagnosed, with limited treatment options and poor prognosis.
A paper on the combination therapy of fruquintinib and paclitaxel was published in Nature Medicine.
As a selective oral vascular endothelial growth factor receptor 1, 2 and 3 inhibitor, fruquintinib can play an anti-tumor effect by blocking tumor angiogenesis. In 2018, this Shanghai original drug was approved for marketing in my country for the treatment of patients with metastatic colorectal cancer. In 2023, fruquintinib was approved for marketing in the United States for the treatment of previously treated metastatic colorectal cancer. From its launch in November 2023 to March this year, the market sales of this drug are approximately US$68 million. It is expected to continue to increase its market share in the future, becoming the first "small molecule, large variety" innovative drug developed by a Shanghai company to cover the world. .
Reports published at the American Clinical Oncology Conference and "Nature Medicine" show that in addition to colorectal cancer, fruquintinib is also expected to treat gastric cancer. This is a 1:1 randomized, double-blind phase III clinical trial conducted at 35 clinical centers in China. It evaluates the combination therapy of fruquintinib and paclitaxel and paclitaxel monotherapy as second-line treatment in 703 patients with advanced gastric cancer or gastroesophageal combined therapy. Comparative test effects on some patients. The research team announced positive results after a statistically significant improvement in progression-free survival, one of the study's dual primary endpoints.
According to reports, the median PFS of patients who received fruquintinib and paclitaxel combination therapy was 5.6 months, while the median PFS of patients who received paclitaxel monotherapy was 2.7 months, a statistically significant improvement. The combination therapy of fruquintinib and paclitaxel also observed statistically significant improvements in multiple other endpoints such as objective response rate, disease control rate, and prolonged duration of response.
In November 2023, fruquintinib was approved for marketing in the United States.
It is reported that the new drug marketing application for the combination therapy of fruquintinib and paclitaxel for the second-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma was accepted by the China National Medical Products Administration in April last year. This Chinese original small molecule drug is expected to bring new treatment options to gastric cancer patients.
The marketing application of fruquintinib in Europe, Japan and other regions around the world is also in progress, and is expected to benefit patients in more countries and regions around the world this year.
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