Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA ® (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations

CHICAGO, ILLINOIS, June 7, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced initial results from the pivotal Phase 2 RAGNAR study evaluating the investigational use of BALVERSA® (erdafitinib), a fibroblast growth factor receptor (FGFR) kinase inhibitor, in patients with advanced solid tumors with prespecified FGFR alterations. At a planned interim analysis (IA), responses were observed across a variety of FGFR-driven solid tumors for patients who had exhausted standard treatment options prior to being treated with BALVERSA®.[1] These results will be featured in an oral presentation (Abstract #3007) today at the 2022 American Society of Clinical Oncology Annual Meeting.RAGNAR (NCT04083976) is a Phase 2 clinical study designed to evaluate the efficacy and safety of BALVERSA® in patients with advanced or metastatic solid tumors and prespecified FGFR gene alterations, regardless of tumor location or histology (tumor-agnostic). The IA was based on 178 patients with 32 distinct solid tumor histologies.[1] Patients in the study were prospectively identified by local molecular testing or central next-generation sequencing (NGS); the most common tumor types were cholangiocarcinoma (bile duct cancer) (n=31), high-grade glioma (tumor of the brain or spinal cord) (n=29), breast cancer (n=14), pancreatic cancer (n=13) and squamous non-small cell lung cancer (n=11).[1] The study also included tumors that occur less frequently in the real world such ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news