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The first interim analysis of the Keynote-426 study showed that the efficacy of Pym monoantigeno-axial therapy for advanced kidney cancer was better than that of single-use schoinib.
this paper aims to evaluate the long-term efficacy and safety of the treatment of patients with advanced kidney cancer compared to the treatment of those with schoinib. the
Keynote-426 study is an ongoing phase 3 clinical trial of randomized open labels, recruiting untreated pathologically examined patients over the age of 18 in 129 locations (hospitals and cancer centers) in 16 countries.
were randomly grouped at 1:1 and treated with Pim monoantitor (200 mg, static drops, 1 time/3 weeks, out of 35 cycles) and assitinib (5 mg, 2 times/day) or schonithinib (50 mg, 1 time/day, 4 weeks, 6 weeks/cycle).
end point of the disease is the overall survival rate and no progress survival rate of the intended treatment population.
between October 24, 2016 and January 24, 2018, 861 patients were randomly assigned to the Pym monoantigenic group (n-432) or the Schoentini monodone group (n-429).
the medium follow-up of 30.6 months (IQR 27.2-34.2), the Pym monoantigenic group had a sustained clinical benefit compared to the Schoini monodynamic group in terms of overall survival and progression-free survival (medium total lifetime: no Reached vs 35.7 months, risk ratio of 0.68, p, 0.0003; medium progress-free lifetime: 15.4 vs. 11.1 months, 0.71, p.lt;0.0001).
The most common treatment-related level 3 or more adverse events in non-progressive survival (both groups occurred in 10% or more patients) were high blood pressure (joint group vs single drug group: 22% vs 20%), elevated alanine transaminase (13% vs 3%) and diarrhea (11% vs 5%).
since the first interim analysis, there have been no new reports of treatment-related deaths.
, by extending follow-up, the results of the Keynote-426 trial showed that Pym monoantigenic assitinib still had better clinical efficacy than Schoinini.
these results continue to support the use of Pym monoantigenic axiostinib as a first-line standard treatment for advanced kidney cancer.
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