VALEMETOSTAT

Valemetostat New Drug Application Submitted in Japan for Treatment of Patients with Adult T-Cell Leukemia/Lymphoma

Retrieved on: 
Tuesday, December 28, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Thought, EZH2, ADC, Quality of life, Daiichi Sankyo, Patient, Peripheral T-cell lymphoma, Paced Auditory Serial Addition Test, DXD, ORR, Cancer, ODD, Incidence, Survival, ATL, Program, Progression-free survival, Research, Alpha, Death, ASH, Adult, Ministry of Health, Labour and Welfare, Technology, Health care system in Japan, EZH1, Laboratory, Society, Cardiovascular disease, NHL, Safety, Orphan drug, Doctor of Philosophy, NDA, PTCL, MHLW, Central, Sustainable development, Prognosis, Pharmaceutical industry, Fine chemical, Health, Limited, Adult T-Cell Leukemia/Lymphoma, Valemetostat, the Pivotal Phase 2 Study, Daiichi Sankyo, ADULT T-CELL LEUKEMIA/LYMPHOMA, VALEMETOSTAT, THE PIVOTAL PHASE 2 STUDY, DAIICHI SANKYO

Valemetostat previously received Orphan Drug designation (ODD) from the Japan MHLW for treatment of patients with relapsed/refractory ATL.

Key Points: 
  • Valemetostat previously received Orphan Drug designation (ODD) from the Japan MHLW for treatment of patients with relapsed/refractory ATL.
  • Valemetostat is the fifth innovative oncology medicine from our pipeline to be submitted for regulatory approval in Japan in the past three years.
  • Valemetostat received ODD from the U.S. Food & Drug Administration for the treatment of PTCL in December 2021, ODD from the Japan MHLW for the treatment of relapsed/refractory ATL in November 2021 and SAKIGAKE Designation from the Japan MHLW for the treatment of adult patients with relapsed/refractory PTCL in April 2019.
  • A total of 25 patients were enrolled in the study in Japan.

Valemetostat Pivotal Data Shows Promising Response Rates in Patients with Adult T-Cell Leukemia/Lymphoma

Retrieved on: 
Saturday, December 11, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Annual general meeting, DXD, Prognosis, Research, NHL, Safety, Thought, Adult, Progression-free survival, ORR, Peripheral T-cell lymphoma, EZH2, Cancer, ADC, EZH1, ODD, Daiichi Sankyo, Death, Gene, Patient, Quality of life, Cardiovascular disease, PTCL, Enzyme, Laboratory, Pit additive, Program, Sustainable development, ATL, MHLW, Alpha, Lymphatic system, Technology, Vaccine, Pharmaceutical industry, Fine chemical, Wood drying, Silviculture, Mortar (masonry), Online gambling, Adult T-Cell Leukemia/Lymphoma, EZH1 and EZH2, the Phase 2 Study, Valemetostat, Daiichi Sankyo, ADULT T-CELL LEUKEMIA/LYMPHOMA, EZH1 AND EZH2, THE PHASE 2 STUDY, VALEMETOSTAT, DAIICHI SANKYO

Secondary endpoints include investigator-assessed ORR, best response in tumor lesions, complete remission rate, tumor control rate, time to response, duration of response, progression-free survival, overall survival and safety.

Key Points: 
  • Secondary endpoints include investigator-assessed ORR, best response in tumor lesions, complete remission rate, tumor control rate, time to response, duration of response, progression-free survival, overall survival and safety.
  • A total of 25 patients were enrolled in the study in Japan.
  • Valemetostat is a potential first-in-class dual inhibitor of EZH1 and EZH2 currently in clinical development in the Alpha portfolio of Daiichi Sankyo.
  • Valemetostat is an investigational medicine that has not been approved for any indication in any country.

Valemetostat Data at EHA Shows Promising Durable Tumor Response in Patients with Peripheral T-Cell Lymphoma and Adult T-Cell Leukemia/Lymphoma

Retrieved on: 
Friday, June 11, 2021
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical trials, Biomarkers, Branches of biology, Biotechnology, Medicine, Life sciences, Chemical pathology, Medical statistics, the Phase 1 Study, VALENTINE-PTCL01 Trial, PTCL and ATL, EZH1 and EZH2, Valemetostat, Daiichi Sankyo, THE PHASE 1 STUDY, VALENTINE-PTCL01 TRIAL, PTCL AND ATL, EZH1 AND EZH2, VALEMETOSTAT, DAIICHI SANKYO

Data from the phase 1 study of valemetostat presented at EHA informed the design of the recently initiated pivotal VALENTINE-PTCL01 study.

Key Points: 
  • Data from the phase 1 study of valemetostat presented at EHA informed the design of the recently initiated pivotal VALENTINE-PTCL01 study.
  • The first cohort will enroll patients with PTCL, and a second cohort will enroll patients with ATL.
  • The study will analyze safety endpoints including adverse events as well as pharmacokinetic and exploratory biomarker endpoints.
  • Up to 176 patients will be enrolled at approximately 70 sites in Asia, Europe, North America and Oceania.