Senhwa Completes Enrollment in Phase 1b CX-5461 Expansion Trial; CSR Expected in Q1 2027

Senhwa Biosciences has completed enrollment in its Phase 1b expansion trial of pidnarulex (CX-5461) monotherapy in patients with advanced solid tumors carrying BRCA1/2, PALB2, or other homologous recombination deficiency (HRD)-associated alterations. The study will move to data review, database lock and comprehensive statistical analysis. Senhwa expects the Clinical Study Report (CSR) in the first quarter of 2027, with final analysis intended to guide indication prioritization, biomarker-based patient selection, potential combination strategies and the next stage of CX-5461 development. Patients benefiting at the end of the main period may enter an extension. The cohort includes heavily pretreated cases across pancreatic, breast and ovarian cancers, with a median of six prior therapy lines.