FDA grants TRE-515 Fast Track status with KRAS G12C inhibitors for previously treated NSCLC. See what the designation means for development and review Trethera Corporation received US FDA Fast Track designation for its deoxycytidine kinase (dCK) inhibitor TRE-515 in combination...
In the phase 1 dose-escalation trial, there were no dose-limiting toxicities up to a dose of 1440 mg, and the investigators focused on collecting biomarker samples that could aid in dose optimization and patient selection for further investigation.1-3 The sponsor...
What is the mechanism of action of TRE-515? TRE-515 is an orally administered, first-in-class small molecule inhibitor of dCK, the rate-limiting enzyme in the nucleoside salvage pathway, which is one of two biosynthetic pathways that generate DNA precursors.Rapid, upregulated DNA...
The FDA has granted fast track designation to KST-6051, an oral pan-KRAS inhibitor, for the treatment of patients with advanced or metastatic solid tumors harboring KRAS mutations, according to a news release from the developer, Kestrel Therapeutics.1 Notably, the clinical...
Inside Setidegrasib’s Phase 3 Development: Targeting KRAS G12D Through Protein Degradation / Astellas, docetaxel, KRAS G12D, KRAS G12D-Mutated NSCLC, Lung Inside Setidegrasib’s Phase 3 Development: Targeting KRAS G12D Through Protein Degradation Astellas announced that the first patient has been dosed...
Transcript: CancerNetwork: Given an OS hazard ratio of 0.18 and a median that was not reached in the KRAS G12C-mutated subgroup, what do you think is biologically distinct about G12C, specifically, vs other KRAS subtypes that could explain such an...
Posted on September 29, 2026 Astellas has dosed the first patient in a Phase III study evaluating setidegrasib in previously treated patients with KRAS G12D mutated advanced non small cell lung cancer. The study will compare the investigational treatment with...
