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A non-randomized Phase I. clinical trial reported by Oaknin, University Hospital of Waller Hebron, Spain, etc., showed that Dostarimab was associated with clinically significant and long-lasting anti-tumor activity and had acceptable safety for patients with endometrial cancer who had mismatched and repaired depression after platinum chemotherapy.
(JAMA Oncol. doi: 10.1001/jamaoncol.2020.4515) mutation misalmed repair mechanism defects may make endometrial cancer antagonic procedure death 1 (PD-1) treatment sensitive.
Dostarlimab (TSR-042) is a PD-1 antibody in study with a high affinity with PD-1 subjects.
To assess Dostarlimab's anti-tumor activity and safety in patients with endometrial cancer with mismatch repair defects, this ongoing, open-label, single-group, multi-center study began Part 1 on March 7, 2016 and began recruiting patients with mismatched repair defects on May 8, 2017.
follow-up time was 11.2 months (0.03 to 22.11 months; based on imaging assessment).
statistical analysis was conducted from 8 July to 9 August 2019.
patients were given Dostarlimab 500 mg every 3 weeks for a total of 4 doses, and then 1000 mg every 6 weeks until the disease progressed, treatment was discontinued or consent was withdrawn.
end point is the objective mitigation rate and duration of the independent central assessment according to the solid tumor response assessment standard version 1.1.
as of the data, a total of 104 patients with endometrial cancer (with a medium age of 64.0 years, ranging from 38 to 80 years of age) were treated with Dostarlimab.
71 of these cases had measurable diseases at baseline and during follow-up at 6 months or more and were included in the analysis.
confirmed that 30 patients received remission (objective remission rate of 42.3%, 95% CI30.6% to 54.6%);
mitigation is sustainable.
the medium mitigation duration (mid-follow-up 11.2 months) was not reached.
expected to maintain mitigation at 96.4 per cent at six months and 76.8 per cent at 12 months.
anemia (3/104 cases, 2.9%), colitis (2 cases, 1.9%) and diarrhea (2 cases, 1.9%) are the most common level 3 or higher treatment-related adverse events.
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