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CheckMate 238 is a randomized, double-blind Phase III trial conducted in 130 academic centers/hospitals in 25 countries in which patients aged 15 years and older who had their IIIB-C or IV melanoma removed received postoperative assisted treatment with nivolumab or ipilimumab.
results of the study showed that the recurrence-free survival and no-distance metastasis survival of patients treated with Navudan were significantly longer than those of Ipi monotherapy.
researchers summarized the efficacy, initial overall survival, and late safety results from the study's last four years.
March 30 - November 30, 2015, a total of 906 patients were randomly assigned to the Navu monoantigroup (453) or the Ipi monoantigroup (453).
51.1 months and 50.9 months, respectively, were followed up in the Navu single resistance group and the Ipi single resistance group.
4-year recurrence-free survival rates in the Navu monoantigroup and the Ipi monoantigroup were 51.7% and 41.2%, respectively (risk ratio of 0.71, 95% CI 0.60-0.86, p=0.0003).
302 expected deaths occurred in 211 cases (100 cases in the Navu monoantigroup (22 per cent) and 111 cases in the Ipi monoantigroup (25 per cent),) and the four-year overall survival rates of the Navu monoantigroup and the Ipi monoantigroup were 77.9 per cent and 76.6 per cent (HR 0.87), 95% CI 0.66-1.14, p=0.31).
of 452 patients in the Navu monotherapy group had 3 late-stage 3-4 treatment-related adverse events (1%) and 7 cases (2%) in 453 patients with Ipi monoanti.
the most common late-stage 3-4 treatment-related adverse events in the Navu single-level resistance group were diarrhea, diabetic ketoacidosis and pneumonia, and in addition to the above-mentioned adverse events, there were colitis (2 cases).
two previous deaths (Ipidant) have been previously reported and have been identified as being related to the study of drug toxicity, with no new deaths.
After 4 years of follow-up, it was confirmed that in patients with phase IIIB-C or PHASE IV melanoma who had been removed, Narvu monoantigen had the benefit of continuous recurrence-free survival compared to Ipi monoantigen, suggesting that Navu monoantigen had long-term therapeutic benefits.
deaths were lower than expected, and the total survival rates of the two groups were similar.
, for patients with high-risk melanoma who have underwent surgery, Navusan resistance is still an effective complementary treatment, and its safety is better than that of Ipi monomatin.
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