The phase 3 trial of CC-486 maintenance therapy obtained positive results

Today, As a maintenance therapy, CC-486 achieved statistically and clinically significant improvements in total survival (OS) and recurrence (RFS) compared to placebos in phase 3 critical trial QUAZAR AML-001 for patients treating acute myeloid leukemia (AML).Based on the positive results of the QUAZAR AML-001 trial, Shishi Shiguibao plans to submit a new drug application (NDA) for CC-486 in the first half of 2020.About CC-486 CC-486 is a DNA methyl transferase inhibitor (DNMT inhibitor) that alters gene expression at the ode genetic level and inhibits the proliferation of cancer cells.In addition to being used in clinical trials to treat AML patients, CC-486 also treats patients with T-cell lymphoma in Phase 2 clinical trials and patients with myeloid growth syndrome (MDS) in Phase 2 and Phase 3 trials.The study on QUAZAR AML-001called QUAZAR AML-001 was a randomized, double-blind, phase 3 trial with a placebo control group. Patients who participated in the trial had medium/low risk AML and had achieved first complete remission (CR) or complete remission and incomplete blood cell count remission (CRi) after undergoing strongly induced chemotherapy.The results showed that at a medium follow-up time of 41.2 months, the patients in the CC-486 treatment group showed significant improvement in OS compared to the placebo, the middle OS in the CC-486 group was 24.7 months, and the placebo group was 14.8 months, reaching the main endpoint of the trial.The patients in the treatment group had a medium RFS of 10.2 months, while the placebo group had 4.8 months. In addition, during treatment, the health-related quality of life (HRQoL) score of CC-486 patients was maintained at a baseline, reaching a critical secondary endpoint of the trial. (Drug Information Network)