Phase II trial of mCRPC combination treatment submitted to FDA
Trovagene, Inc. announced that the filing of its protocol for a phase II clinical trial of PCM-075 in combination with abiraterone acetate (ZYTIGA), for metastatic castration-resistant prostate cancer has been submitted to the FDA for review. In this multicenter, open-label, phase II trial, PCM-075 in combination with the standard dose of abiraterone and prednisone, all administered orally, will be evaluated for safety and efficacy. The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment, as defined by lack of PSA progression in patients who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving androgen deprivation therapy plus abiraterone and prednisone.
Companies announce agreement to develop new prostate cancer tests
Genomic Health, Inc. and Cleveland Diagnostics, Inc. have announced an exclusive licensing agreement to develop and commercialize new prostate cancer tests based on Cleveland Diagnostics’ IsoPSA reagents and technology. Initial efforts under this agreement will focus on Genomic Health’s development of a high-PSA reflex test to accurately predict the presence of high-grade cancer (Gleason score ≥7) prior to prostate biopsy. IsoPSA is a reagent that interrogates the entire spectrum of structural changes, or isoforms, of complex PSA, which Genomic Health intends to develop and commercialize as an in vitro diagnostic blood-based test. Using Cleveland Diagnostics’ proprietary solvent interaction analysis technology platform, the IsoPSA assay can be integrated into the workflow of a urology laboratory practice to distinguish cancer-related PSA isoforms from benign isoforms to detect prostate cancer more precisely than standard PSA testing alone, the companies said.
First patient dosed in phase Ib trial of advanced urothelial cancer agent
Seattle Genetics, Inc. and Astellas Pharma Inc. recently announced dosing of the first patient in EV-103, a phase Ib clinical trial evaluating the safety and tolerability of enfortumab vedotin in combination with pembrolizumab (Keytruda) or atezolizumab (Tecentriq), two types of immune checkpoint inhibitor therapies, for first- or second-line treatment of patients with locally advanced or metastatic urothelial cancer. Enfortumab vedotin is an investigational antibody-drug conjugate designed to deliver the cell-killing agent monomethyl auristatin E to the target Nectin-4. The primary objective of the trial is to assess the safety and tolerability of enfortumab vedotin in combination with checkpoint inhibitor therapy.