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Rindopepimut is a vaccine for specific expressions of EGFR mutants (EGFRvIII) tumors, and previous phase II clinical trial studies have shown that Rindopepimut is associated with non-progressive survival (PFS) and overall survival (OS) extension in adult patients with well-to-do, EGFRvIII-positive expressions.
study by David A. Reardon of the Dana Faber Cancer Institute in Boston, Massachusetts, USA, and others found that the use of Rindopepimut to improve prognostication in patients with EGFRVIII-positive relapsed GBM was published online in February 2020 in Clinical Cancer Reseach.
the study was conducted in 26 U.S. hospitals in a placebo-controlled, randomized double-blind Phase II clinical trial (NCT01498328).
researchers randomly divided 73 relapsed GBM patients who received EGFRvIII-positive treatment between May 2012 and May 2014 into two groups: 36 cases of Redopepimut and Beval monoantigen therapy;
study endpoint indicator is a six-month progress-free lifetime (PFS-6).
results, there was no significant difference in baseline characteristics in patients.
two groups of patients who survived without progression for 6 months: 10 in the Rindopepimut group (28%), and 6 (16%) in the control group, with no significant difference (P-0.12).
3.7 months for the middle PFS in both groups, and more patients in the Rindopepimut group who were more than 6 months old (HR=0.72; 95% CI, 0.43-1.21; P=0.22).
compared to the control group, the secondary endpoint indicator and the exploration endpoint indicator are also beneficial to the Redopepimut group, including statistically significant survival advantages (HR=0.53; 95%CI, 0.32-0.88; P=0.01), with a higher overall response rate (ORR=30%:18%;P 1 <8> .38), longer median reaction period, 7.8 months (95% CI, 3.5-22.2) compared to 5.6 months (95% CI, 3.7-7.4) and higher resistance to deactivation steroids (33%:0%).
80% of Patients treated with Rindopepimut achieved anti-EGFRvIII titration (1:12,800), which was associated with extended lifetime (HR=0.17; 95% CI, 0.07-0.45; P.0001).
20% (95% CI, 9%-35%) in the Rindopepimut group and 3% (95% CI, 0%-12%) in the control group (P-0.0179).
using Cox regression models, Rindopepimut was a factor in patient prognostic improvement.
patients with good resistance to Therindopepimut and Beval monoantigen.
use of Rindopepimut did not cause serious adverse reactions.
the toxic reaction of Rindopepimut was a short, low-level local reaction.
patients with erythema and itching at the injection site.
3 percent of cerebral edema occurred in the Redopepimut group and 8 percent in the control group.
results showed that Rindopepimut combined with beval monoantimmune therapy for relapsed GBM patients, improved survival rate, no serious adverse reactions.
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