Disease Introduction
Melanoma is a malignant tumor that originates from skin pigment cells (melanocytes). It is highly malignant and prone to early metastasis. However, in recent years, significant progress has been made in immunotherapy and targeted therapy, enabling many patients with advanced-stage melanoma to achieve long-term survival.
Cutting-edge high-precision diagnostic and treatment technologies
- TIL cell therapy : Tumor-infiltrating lymphocytes (TILs) are isolated and expanded from the patient's own tumor and then reinfused to kill the tumor. The world's first TIL therapy, lifileucel, received accelerated approval from the US FDA in early 2024 for unresectable or advanced melanoma that has failed previous PD-1 immunotherapy (those with BRAF mutations also need to have used targeted drugs). The real-world objective response rate is about 35%, and some patients have maintained a response for more than 2 years.
- Dual Immunotherapy Upgrade : Nivolumab (PD-1) combined with piracetamab (LAG-3 inhibitor, combination therapy Opdualag) as first-line treatment for advanced melanoma. Compared with nivolumab monotherapy, the median progression-free survival was extended from 10.6 months to 15.7 months, the risk of death was reduced by about 22%, and the hepatotoxicity was significantly lower than that of the traditional CTLA-4 dual immunotherapy combination. The 3-year recurrence-free survival rate after adjuvant therapy reached 72% (63% in the monotherapy group), which is the first LAG-3 targeted adjuvant therapy.
- BRAF/MEK targeted combination : For patients with BRAF V600 mutations, the combination of dabrafenib and trametinib resulted in a 7-year overall survival rate of 71% after adjuvant therapy (compared to 45% in the placebo group); the pathological response rate of neoadjuvant therapy before surgery was approximately 78%, and the risk of recurrence after surgery was reduced by approximately 60%, making it suitable for rapid tumor shrinkage in patients with large tumor burden and rapid progression.
- Domestic Innovation and First-Line Immunotherapy : The MELATORCH Phase III study of the domestically produced PD-1 monoclonal antibody toripalimab as first-line treatment for advanced melanoma significantly reduced the risk of disease progression or death by 29.2%, and the related new indication marketing application was accepted by the NMPA in August 2024; the Phase II data of the Chinese self-developed TIL therapy GC101 (Norgrence) for advanced melanoma has been published, and it is planned to apply for marketing approval in 2026.
