TQB3455 / Sino Biopharm - LARVOL DELTA

TQB3455 Plus Azacitidine in Patients with Newly Diagnosed, Mutant-IDH2 Acute Myeloid Leukemia and Myelodysplastic Syndrome: A Phase 1 Trial (ASH 2024) - "Conclusion : TQB3455 plus azacitidine was a well-tolerated, and effective therapy for newly diagnosed, mutant-IDH2 AML ineligible for intensive chemotherapy and MDS. The randomized study will be launched soon to explore the superiority of the therapy."

Clinical • P1 data • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Myelodysplastic Syndrome • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • ASXL1 • DNMT3A • IDH2 • WT1

Phase I Study of TQB3455, a Selective Inhibitor of IDH2 with Favorable Safety and More Potent Efficacy to IDH2-R172K Mutation, for Acute Myeloid Leukemia and Myelodysplastic Syndrome (ASH 2022) - "Enasidenib (ENA), the first selective IDH2 inhibitor, was associated with impressive response rates in relapsed/refractory (R/R) AML and was approved by FDA in 2017. TQB3455 is well-tolerated for myeloid malignancy at the R2PD of 100 mg qd. It also yield high rates of clinical response in pts with mIDH2 AML. Patients with IDH2-R172K mutation fared much better than IDH2-R140Q/W with regard to response, this is in line with outcome of TQB3455 in vitro but different from previous reports of ENA."

Clinical • P1 data • Acute Myelogenous Leukemia • Alopecia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Myelodysplastic Syndrome • Pneumonia • Respiratory Diseases • Transplantation • FLT3 • IDH2

A Study of TQB3455 Tablets in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • IDH2

A Study of TQB3455 Tablets in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1 trial