NMPA approves Dapeng Pharmaceuticalantiphre anti-cancer drug Lonsurf for treatment of patients with metastatic colorectal cancer

Japanese pharmaceutical company DapengPharmaceutical(http:// announcedthat China's NationalMedicines(http://Regulatory Authority (NMPA) has approved the anti-cancer drug Lonsurf (trifluridine/tipiracil), developed code TAS-102, for the treatment of patients with metastatic colorectal cancer (mCRC)About Lonsurf
Lonsurf (TAS-102) is a new oral anti-metabolicdrug(http://consisting of the anti-tumor nucleoside analogue FTD (trifluridine) and thoracic phosphatine inhibitor TPI (tipiracil), FTD can replace thymosin in the DNA replication process directly into the DNA double-stranded, leading to DNA dysfunction, interference with cancer cells DNAsynthesis(http://, TPI can inhibit the risk of FTD-related thymosin e The full results of the study were published in the Journal of Clinical Oncology in 2017 results showed that the study reached its main endpoint: the risk of death in the TAS-102 treatment group was significantly reduced by 21% compared to the placebo group (HR: 0.79, 95% CI: 0.62-0.99, nosebon rank p-0.0 35), median total lifetime (OS) significantly extended (median OS: 7.8 months (95% CI: 7.1-8.8) vs 7.1 months (95% CI: 5.9-8.2) The results validated the OS results observed in the International Phase III study RECOURSE: tAS-102 treatment group had a 31% reduced risk of death and a significant lysinos significantly longer (7.2 months vs 5.2 months, p 0.0001) compared to the placebo group 　　Subgroup Analysis (http:// of the TERRA study showed that the observed OS benefit was not affected by the KRAS mutation, as follows: the TAS-102 treatment group had a 23% lower risk of death in wild KRAS patients compared to the placebo group (HR-0.77, 95% CI: 0 57-1.04, nogital rank p.0.083), reduced risk of death by 17% in patients with mutant KRAS (HR-0.83,95% CI: 0.57-1.20, xarate rank p-0.228) The TAS-102 treatment group compared to the placebo group in patients with wild-type KRAS (8.6 months (95% CI: 7.4-10.7) vs 7.4 months (95%CI: 5.6-9.2) ) similar to the median OS benefit results observed in patients with mutant KRAS (7.0 months (95% CI: 5.4-8.0) vs 6.5 months (95% CI: 4.6-7.6) 　　The risk-free survival of the disease (PFS:HR:0.43 (95% CI: 0.34-0.54), the nogital rank p.001) and the duration of treatment failure (TTF: HR s.46(95% CI:0.37-0.58), the risk ratio of the no-progress order p.0.001) is favorable to the tAS-10 group of treatment (HR) In terms of disease control rate (DCR), TAS-102 was significantly higher than in the placebo group (44.1% vs 14.6%, p0.001) safety in the study, TAS-102 was well tolerated and toxic in line with previous studies