Gastrointestinal stromal tumor (GIST) is a tumor driven by genetic mutations, and more than 85% of patients with GIST carry KIT or PDGFRA mutations. Ripatinib, as a broad-spectrum KIT and PDGFRA switch control inhibitor, has outstanding performance in the global phase III INVICTUS study, becoming the first fourth-line standard treatment drug for GIST. In June 2022, the fourth-line bridging study of Ripatinib in China was published in the international journal Clinical Cancer Research (CCR), which is very exciting. We specially invited the leading PI of this study and Professor Shen Lin of Peking University Cancer Hospital to share the research results and the experience of conducting clinical research on rare tumors such as GIST.
Division of Gastrointestinal OncologyDirector
Director of Phase I Clinical Trial Ward< /p>
Served as Vice President of Peking University Cancer Hospital, Beijing Deputy Director, City Cancer Institute
Chairman of the Chinese Anti-Cancer Association Cancer Precision Therapy Professional Committee
< span>The first chairman of the Chinese Anti-Cancer Association Oncology Drug Clinical Research Professional Committee
Chinese Society of Clinical Oncology Chairman of the Clinical Research Expert Committee
Chairman-designate of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology< /span>
Vice-chairman of Colorectal Cancer Professional Committee of China Anti-Cancer Association
Rotating Chairman of the Council of Beijing Cancer Prevention Society
Recognized, Ripatinib Chinese fourth-line bridging study is a major international journal
Professor Shen Lin: After GIST patients progressed on third-line therapy, there was no standard therapy for fourth-line therapy. A controlled, phase III INVICTUS study. The results showed that Ripatinib achieved good efficacy and safety in fourth-line GIST patients, and Ripatinib was also approved by the U.S. Food and Drug Administration (FDA) for fourth-line GIST in 2020. treat. For various reasons, China did not participate in the global clinical study of Ripatinib, so we conducted a premarketing fourth-line bridging study in the Chinese population. The Chinese fourth-line bridging study of Ripatinib showed that its clinical benefit and safety profile in the Chinese GIST population were consistent with the INVICTUS study. We are also very pleased to see the results of this study published in the international journal Clinical Cancer Research, which shows that the evidence of the efficacy and safety of ripatinib in Chinese GIST patients has been globally recognized. On March 31, 2021, Ripatinib was approved for marketing in China, changing the treatment pattern of GIST in my country in one fell swoop. Ripatinib has been on the market for one year, and its efficacy, safety and patient compliance in clinical practice are very good. On the basis of more than one year of clinical drug experience, the release of the results of the Chinese population bridging study further enhances our confidence in using this drug in clinical practice, and the trust of patients will further increase. In addition, the success of this bridging study also increases our research experience in rare tumors, and brings inspiration to clinical practice and future clinical trials.
Safe and effective, Ripatinib is effective again in Chinese GIST patients
Shen Prof. Lin: The China Fourth-Line Bridging Study is a multicenter Phase II study in Chinese patients, aiming to demonstrate the consistency with the results of the Phase III INVICTUS study. The study enrolled Chinese patients with advanced GIST who had progressed on at least three tyrosine kinase inhibitors (TKIs), imatinib, sunitinib, and regorafenib, to receive ripatinib 150 mg QD Treatment, primary endpoint is progression-free survival (PFS) by independent radiographic assessment (IRR), secondary endpoints include objective response rate (ORR) by IRR assessment, overall survival (OS), and analysis of safety and pharmacokinetics Learning (PK) data. A total of 39 patients were enrolled in the study, of which 38 were included in the efficacy analysis set, and 39 were included in the safety analysis set. The results of the study showed that the median PFS of the patients was 7.2 months, the ORR was 18.4%, the disease control rate (DCR) was 52.6%, and the median duration of response (DOR) was nearly 6 months. The median OS has not yet been reached, and the 1-year OS rate has reached 65.0%, and the curative effect is very good. Ripatinib also has a good safety profile, with a grade 3-4 treatment-related adverse reaction (TRAE) rate of 15.4%. Repatinib is a novel switch-controlled inhibitor with broadInhibits KIT and PDGFRA mutations. This bridging study confirmed that the efficacy and safety of ripatinib in Chinese patients with advanced GIST were consistent with the INVICTUS study, and the results of this study supported the use of ripatinib as a fourth-line or above treatment option for Chinese GIST patients.
Set an example and inspire the development of rare cancer drugs in China
< span>Professor Shen Lin: GIST is a rare disease in my country, accounting for about 1% of gastrointestinal malignant tumors. Due to the small number of patients with GIST, and the prognosis of patients is related to the number, size, metastasis, and location of the tumor, and the heterogeneity is strong, it is difficult to carry out large-scale randomized controlled clinical trials. According to international rare tumor research and development rules and relevant guidelines for rare disease clinical research in my country, using important information from the INVICTUS study data, we confirmed in a bridging study that Ripatinib has similar efficacy and safety in the Chinese population. At present, Ripatinib has been successfully marketed in China and has been recommended by the guidelines of the Chinese Society of Clinical Oncology (CSCO). In recent years, my country has vigorously supported the research and development of rare disease drugs. The fourth-line bridging study of Ripatinib in China is an important step for us in rare tumor research. GIST patients who have progressed on third-line therapy can now obtain effective drugs to control tumor progression in a timely manner. I think the future research in this field will never stop. The current study found that for patients with KIT exon 11 mutation who failed imatinib treatment, the efficacy of second-line treatment of ripatinib is similar to that of sunitinib. There are differences in advantages, and whether greater advantages can be found in selected groups in the future is worthy of further exploration. Review: XYTypesetting: XYExecution: XY< mpprofile class="js_uneditable custom_select_card mp_profile_iframe" data-alias="medlive-oncology" data-from="1" data-headimg="http://mmbiz.qpic.cn/mmbiz_png/AtTmw2081Jh1bDXU61p7xq9iaicFZ4LHl0Ms5KOJYzYibM0fVIknfaFC dataIMf0g41ZBodeW4YRv0GbUxrnjjBodeW4YRv0GbUxrnj -id="MjM5MTAzNjUyMA==" data-nickname="Yimaitong Oncology" data-pluginname="mpprofile" srcignature="Follow the medical oncology department, quickly get the progress in the field of oncology at home and abroad, check the guideline updates in time, and be the first Know what's trending about conferences.">