Daiichi Sankyo registers Phase 3b T-DXd sequencing trial; posts RWE and access-program studies

Daiichi Sankyo's registry activity for the week spans a new interventional trial, a completed observational study, and an expanded access program.

• A phase 3b trial called "DB-Guide" is recruiting to test a sequential regimen in first-line HER2+/HR+ advanced or metastatic breast cancer. The study starts with upfront T-DXd plus pertuzumab for 18 to 24 cycles, transitions to trastuzumab plus pertuzumab plus endocrine therapy plus palbociclib, and gives T-DXd again as second-line therapy once patients progress on that maintenance regimen.¹ The trial is sponsored by Daiichi Sankyo with AstraZeneca as collaborator, and plans to enroll 200 participants.¹
• A retrospective observational study, the "ERENAL" study, has completed in South Korea and Taiwan. It was designed to evaluate recommended once-daily dosing of edoxaban and rivaroxaban in atrial fibrillation patients with renal dysfunction in South Korea and Taiwan,² enrolling 8265 participants (actual).²
• Daiichi Sankyo has opened a Medical Access Program making valemetostat tosylate available to patients with relapsed/refractory peripheral T-cell lymphoma. The program offers an alternative treatment option for patients with PTCL who are ineligible for clinical trials, providing access to valemetostat tosylate, a medicinal product that has received marketing authorisation in Japan,³ with a recommended starting dose of 200 mg once daily in continuous 28-day cycles.³