Astellas Pharma (Japan)

Dual-component CAR T cell therapy: targeting BCMA with convertible CAR and MicAbodies

Abstract Background Chimeric antigen receptor (CAR) T cells targeting B cell maturation antigen (BCMA) have demonstrated considerable therapeutic advantages in treating multiple myeloma (MM) patients, increasing progression-free survival and overall survival compared to standard-...

Real-World Longitudinal Treatment Outcomes for Patients with Metastatic Castration-Sensitive Prostate Cancer in Japan

With recent approvals in Japan, identifying optimal first-line therapy for metastatic castration-sensitive prostate cancer (mCSPC) is critical. We evaluated real-world outcomes of androgen-deprivation therapy (ADT) plus androgen receptor signaling inhibitors (ARSIs) as first-line...

A Cautionary Note on Regional Consistency Evaluation With Multiple Primary Endpoints in Multiregional Clinical Trials

In multiregional clinical trials (MRCTs), regional consistency probabilities (RCPs) must be evaluated at the trial design stage in addition to the power for the entire trial population. The Japanese Ministry of Health, Labour and Welfare guidance proposes two widely used criteria...