Shuvotinib is often broadly classified as a "third-generation" EGFR targeted drug, but strictly speaking, it is a novel highly selective EGFR-TKI targeting EGFR20 exon insertion mutations and cannot be simply classified as a traditional 1/2/3 generation.
Remember that 'focusing on 20 ins' is more important than' counting generations'.
1、 Why is it said that it is not an ordinary 'third generation'
The core of traditional third-generation drugs is to overcome T790M resistance
Like Axitinib, it mainly solves the problem of T790M resistance that occurs after EGFR sensitive mutations.
2. The design goals of sunitinib are different
It mainly targets EGFR20 exon insertion mutations (exon20ins), which have a unique spatial conformation and are generally ineffective in traditional 1/2/3 generation drugs.
3. Therefore, a more accurate positioning is "the new/highly selective EGFR-TKI after the third generation"
It is not a typical third-generation medicine, nor is it a second-generation medicine. Saying it is the 'second generation' is a clear mistake.
2、 What problem does it truly solve
1. Target audience
Advanced non-small cell lung cancer with EGFR20 exon insertion mutations accounts for approximately 2% -4% of all non-small cell lung cancers.
2.Why is it particularly difficult to treat
This type of mutation is insensitive to traditional EGFR targeted drugs such as gefitinib and osimertinib, and has mainly relied on chemotherapy in the past. The median progression free survival is about 7 months.
3. Key data of sunitinib
In the first-line phase III study, the median progression free survival of the sunitinib group was 10.3 months, the risk of disease progression or death was reduced by 35%, and the objective response rate was approximately 59% -68%, significantly better than chemotherapy.