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Bristol Myers Squibb reports that the Independent Data Monitoring Board (DMC) has reviewed data from Opdivo's CheckMate-548 Phase III clinical trial.
, the Committee assessed that the trial could not reach the main end of total survival (OS).
after a routine review of the study by the DMC, Pam was told that based on trial data to date, the study would not be able to meet the primary endpoint of overall survival for patients who did not use baseline corticosteroid hormones.
that although no safety risks were observed in patients treated with Opdivo, research had to be stopped.
Based on DMC's recommendations, researchers will not blindly participate in the treatment distribution of patients in the study, and in the future will provide advice on treatment options for patients participating in the trial, and patients who currently benefit from Opdivo treatment can continue treatment if doctors agree.
CheckMate-548 trial is a randomized, multi-center Phase III clinical study in which participants were mainly newly diagnosed with O6-methyl ostrich-DNA methyl transferase (MGMT) methylated GBM patients, with the aim of comparing the efficacy and safety of Opdivo's combined standard treatment options (Timoazamine-radiation therapy) relative to the individual application of standard treatment options.
Opdivo is a PD-1 immuno-checkpoint inhibitor that fights cancer by harnessing the body's own immune system, and has been approved to treat multiple types of tumors.
polygonal glioblastoma is the most common and invasive type of primary malignancies of the central nervous system, with a five-year survival rate of less than 5%.
about 300,000 confirmed GBM patients worldwide each year, and about 240,000 die from cancer of the brain or central nervous system.
current standard clinical treatment for newly diagnosed GBM patients includes surgery, followed by radiotherapy and chemotherapy, but treatment options are relatively limited.
methylation status of MGMT (O6-methyl ostrich-DNA methyl transferase) is one of the most commonly used biomarkers in GBM treatment guidance.
that MGMT methylation can predict the response of GBM patients to treatment.
said it would complete a comprehensive assessment of CheckMate-548 data in the future and work with researchers to publicly share the final results with the oncologist community.
was affected by the short news, Shishi Shiguibao shares fell 0.1 percent in pre-market trading on Wednesday.
source: 1. Bristol Myers Squibb Announces Update on Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme 2.Bristol Myers Squibb's Opdivo Brain Brain Trial Fail Fail Mid-Assessment