The trial aims to recruit approximately 356 participants to evaluate the efficacy of setidegrasib compared to docetaxel. The primary endpoints focus on progression-free survival and overall survival. This study marks a significant escalation in Astellas' clinical program, representing the second Phase 3 investigation for the drug initiated within the last six months, following a study launched in April for pancreatic ductal adenocarcinoma.

Setidegrasib operates by hijacking the cell's internal machinery to identify and eliminate the disease-driving KRAS G12D protein. With no currently approved therapies specifically addressing this mutation, patients with this profile have relied on broad systemic chemotherapy. Clinical data published earlier this year in The New England Journal of Medicine provided the initial impetus for this trial, demonstrating manageable safety and antitumor activity. Researchers are scheduled to present further translational findings regarding mechanisms of resistance and potential combination strategies at the upcoming AACR Conference on Pancreatic Cancer.