Core Insights - The approval of the dual immunotherapy regimen for the treatment of resectable IIB-III stage MSI-H/dMMR colorectal cancer marks a significant breakthrough in the field of immunotherapy for colorectal cancer [1][3][4] - This therapy is the first and only dual immunotherapy regimen approved globally for neoadjuvant treatment in colorectal cancer, potentially changing treatment paradigms for patients with this specific cancer type [1][3] Group 1: Treatment Approval and Characteristics - The National Medical Products Administration approved the new drug application for Daberxin (Ipilimumab N01 injection), which can be used in combination with Daberush (Sintilimab injection) for neoadjuvant therapy in patients with resectable IIB-III stage MSI-H/dMMR colorectal cancer [1] - MSI-H/dMMR colorectal cancer accounts for approximately 15% of all resectable colorectal cancer cases, and these tumors are less responsive to traditional chemotherapy [1][3] Group 2: Clinical Implications and Efficacy - Existing treatments for locally advanced MSI-H/dMMR colorectal cancer primarily involve radical surgery and postoperative adjuvant chemotherapy, with a recurrence or metastasis rate of 10%-30% among patients [3] - The dual immunotherapy regimen has shown to significantly increase the pathological complete response rate in neoadjuvant therapy, potentially reducing the need for postoperative adjuvant chemotherapy [3][4] Group 3: Patient Considerations and Safety - For patients with MSI-H/dMMR colorectal cancer, surgery may not be the only option due to the challenges associated with radical surgery and poor prognosis [4] - While the dual immunotherapy regimen is generally considered safe and controllable, there are potential immune-related adverse reactions that may occur, necessitating timely medical intervention for severe cases [4]
新突破！全球首个结肠癌新辅助治疗的双免疫方案获批在华上市