Keytruda-chemotherapy first-line treatment of advanced or metastatic urinary tract skin cancer phase III clinical failure

On June 9EST, Mershadon announced the results of a Phase III clinical trial called KEYNOTE-361The study, which assessed the efficacy of Keytruda's combination chemotherapy for advanced or metastatic urinary skin cancer (UC), showed that Keytruda combined chemotherapy did not reach the dual primary endpoint of total survival (OS) and non-progressive survival (PFS) compared to standard chemotherapyKEYNOTE-361 (NCT028533305) is a randomized, open-label phase 3 clinical trial in which 1,010 patients with previously untreated advanced or metastatic UC were recruited, with patients randomly divided into three groups, each receiving Keytruda monodrug, Keytruda combined chemotherapy or individual chemotherapy treatment:Keytruda plus chemotherapy group: 3 weeks a cycle, 200mg Keytruda intravenously on the first day of each cycle, up to 35 cycles, 1st day or 2nd day of each cycle plus cisplatin (70mg/m2) or calplatin (AUC5 intravenous injection or AUC4.5 intravenous injection), 1st day and 8th day of each cycle Gixithabin (1000mg/m2 intravenously);Keytruda single drug group: 200mg Keytruda intravenously on the first day of each cycle, up to 35 cycles;separate chemotherapy group: use cisplatin or calpheriton on the first or second day of each cycle; 1st and 8th day of each cycle plus gheitabinIn addition to the main endpoints of OS and PFS, the secondary endpoints of the trial included link duration, disease control rate, and overall remission rateresults showed that both the OS and PFS indicators of the Keytruda combined chemotherapy group improved, but were not statistically significant, compared to chemotherapy aloneSince there is no known advantage of OS or PFS for Keytruda combined chemotherapy, the study's single-drug treatment group has not yet conducted a formal statistical analysis of the efficacy, and detailed results of the future KEYNOTE-361 will be presented at an upcoming medical conference and discussed with regulators, Mercado saidKeytruda as Merchadon's "house flower" and although the results of the trial were disappointing, the drug now has three FDA-approved bladder cancer indicationsMercado has extensive clinical development programs for bladder cancer, including Keytruda monodrug and combinations with other anticancer therapies, involving metastatic, muscular immersion, non-muscular immersion and other types and stages of bladder cancerSource:1, Merck and Co.' Keytruda Misses goals in Phase III advanced bladder cancer trial2, Merck Provides Update on Phase 3 KEYNOTE-361 Trial StyrolyTHa ® (pembrolizumab) as Monotherapy