Kidney cancer "immunity + target" first-line treatment! Combination therapy of mosadon and Pfizer keytruda + inlyta approved by EU

September 5, 2019 / BIOON / -- cancer immunotherapy giant Merck & Co recently announced that the European Commission (EC) has approved keytruda (coreda, common name: pembrolizumab, pabolizumab) combined with Pfizer A new generation of renal cancer targeting drug, inlyta (axitinib, acitinib; tyrosine kinase inhibitor [TKI]), is used for the first-line treatment of advanced renal cell carcinoma (RCC) patients This approval includes all patients in the imDC risk group This ratification applies to all 28 EU Member States as well as Iceland, Liechtenstein and Norway In the United States, FDA approved keytruda and inlyta in April this year for first-line treatment of patients with advanced RCC, two months ahead of the expected approval time It is worth mentioning that keytruda is the first anti-PD-1 therapy approved in Europe as part of the portfolio for all imDC risk group RCC treatments The approval was based on the results of key phase III clinical study keynote-426 (nct02853331), which showed that in patients with advanced RCC, keytruda + inlyta protocol reduced the risk of death by 47% (HR = 0.53 [95% CI: 0.38) compared with SUTENT, the first-line standard care drug for advanced RCC, At the same time, PFS and orr were improved Keynote-426, a randomized, multicenter, open label study, was conducted in 861 patients with advanced RCC who had not received systematic therapy before (regardless of the expression of tumor PD-L1) The keytruda + inlyta regimen was compared with SUTENT, a first-line standard nursing drug for advanced RCC In the study, patients were randomly assigned to two treatment groups: (1) keytruda + inlyta treatment group, receiving 200mg of keytruda intravenously once every three weeks, while taking 5mg of inlyta orally twice a day; (2) SUTENT treatment group, receiving 50mg of SUTENT once a day, lasting for 4 weeks and 2 weeks All patients continued to receive treatment until disease progression or unacceptable toxicity was confirmed Keytruda was treated for up to 24 months Detailed results from the study were published in February this year at the 2019 ASCO-GU The data showed that keytruda + inlyta regimen showed statistically significant improvement in total survival (OS), progression free survival (PFS), objective response rate (ORR) and controllable safety compared with SUTENT, the first-line standard nursing drug for advanced RCC These data suggest that keytruda + inlyta should be the new standard of care for these patients The detailed data released at ASCO-GU meeting are as follows: the study reached the main end points of OS, PFS and orr: (1) compared with SUTENT treatment group, keytruda + inlyta treatment group significantly improved OS and reduced the risk of death by 47% (HR = 0.53 [95% CI: 0.38), 59 events (14%) were observed in keytruda + inlyta treatment group (n = 432), 97 events (23%) in SUTENT treatment group (n = 429), and the OS in both treatment schemes was not reached (2) Compared with SUTENT group, keytruda + inlyta group also showed a 31% reduction in PFS, disease progression or death risk (HR = 0.69 [95% CI: 0.57,0.84], P = 0.00012); keytruda + inlyta group had 183 events (42%), SUTENT group had 213 events (50%); keytruda + inlyta group had a median PFS of 15.1 months (95% CI: 12.6), 17.7), the median PFS in SUTENT group was 11.0 months (95% CI: 8.7,12.5) (3) The orr of keytruda + inlyta group was 59% (95% CI: 54,64) and SUTENT group was 36% (95% CI: 31,40) (P < 0.0001) (4) The median dor of keytruda + inlyta group was not reached (range: 1.4 + to 18.2 + months), while that of SUTENT group was 15.2 months (range: 1.1 + to 15.4 + months) (5) In all subgroups, including all imDC risk and PD-L1 expression subgroups, therapeutic benefits of keytruda + inlyta were observed (6) The incidence of grade 3-5 treatment-related adverse events was 76% in keytruda + inlyta group and 71% in SUTENT group Professor Thomas Powles, chief researcher of keynote-426 and director of Bates cancer center, said: "advanced renal cell carcinoma is one of the most lethal cancer types, and most patients die within five years after the initial diagnosis Encouragingly, we can now offer keytruda + inlyta combination as a first-line treatment for patients in Europe " Dr Scot Ebbinghaus, vice president of clinical research, moshadong research laboratory, said: "the approval of keytruda + inlyta joint program for the treatment of advanced RCC in Europe marks an important milestone Providing an additional treatment option is particularly important for patients with advanced renal cell carcinoma and underscores our commitment to developing keytruda for areas where demand is not met " Keytruda belongs to PD-1 tumor immunotherapy, which is a kind of tumor immunotherapy with great attention at present It aims to use the immune system of human body to resist cancer, and block the PD-1 / PD-L1 signal pathway to make cancer cells die It has the potential to treat many types of tumor The drug, developed by Pfizer, is an oral therapy designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2, and 3, which may promote tumor growth, angiogenesis, and cancer progression (tumor spread) SUTENT, also developed by Pfizer, is a multi receptor tyrosine kinase inhibitor and a standard nursing drug for the first-line treatment of RCC in the past 10 years Renal cell carcinoma (RCC) is the most common type of renal cancer so far, accounting for 90% of all cases of RCC The incidence rate of RCC in males is 2 times that of females Variable risk factors include smoking, obesity, workplace exposure to certain substances and high blood pressure In 2018, there were about 403000 confirmed cases of renal cancer and about 175000 deaths worldwide In Europe, it is estimated that 136500 new cases of renal cancer were confirmed in 2018, and about 54700 people died of the disease Original source: MSD company