Agents for bladder cancer, prostate cancer, and stress urinary incontinence are also included in this round-up of pipeline developments.
The FDA has accepted Bristol-Myers Squibb’s supplemental biologics license application for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously granted breakthrough therapy designation for this application, which is the second indication for which the Opdivo-plus-Yervoy combination has received this designation. The application is based on data from the phase III CheckMate –214 study, which was stopped early based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival.
TARIS Biomedical LLC, and Bristol-Myers Squibb have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS), in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor nivolumab (Opdivo). The phase Ib trial will evaluate the combination in patients with muscle-invasive bladder cancer who are scheduled for radical cystectomy. TAR-200 is TARIS Biomedical’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder over 7 days.
Sophiris Bio Inc. said it has completed enrollment in its phase IIb study to evaluate the safety and tolerability of topsalysin (PRX302) in treating men with clinically significant localized prostate cancer. Topsalysin is an innovative, first-in-class transmembrane pore-forming protein genetically modified to be activated only in the presence of enzymatically active PSA, which is only found within the prostate. The multicenter, open-label study is evaluating the safety and efficacy of targeted intraprostatic administration of topsalysin for the treatment of histologically proven, clinically significant, localized prostate cancer.
Next: 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.
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.
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.
Next: FDA grants breakthrough designation to RCC treatment
The FDA has granted breakthrough therapy designation for avelumab in combination with axitinib (INLYTA) for treatment-naïve patients with advanced renal cell carcinoma (RCC). The designation is based on the preliminary evaluation of clinical data from JAVELIN Renal 100, a global phase Ib study assessing the safety and efficacy of avelumab in combination with axitinib for the treatment of treatment-naïve patients with advanced RCC. Updated results from this phase Ib study were presented at the 2017 American Society of Clinical Oncology annual meeting in Chicago.
Researchers at Roswell Park Cancer Institute, Buffalo, NY, and several other sites are conducting a phase I clinical trial of an immunotherapy for men with metastatic prostate cancer that has progressed in spite of standard treatment. The trial centers on MOR209/ES414, a special type of antibody that researchers hope will guide the patient’s T cells to seek out prostate-specific membrane antigen. The science behind the clinical trial is based on results of clinical trials for a similar immunotherapy called blinatumomab (Blincyto), which is FDA-approved for the treatment of acute lymphoblastic leukemia. Participants receive MOR209/ES414 in a continuous infusion through a pump that’s worn as a “fanny pack” and visit the GU Center at Roswell Park twice per week for 6 months.
GTx, Inc. recently provided updates on its investigational products for stress urinary incontinence (SUI) and prostate cancer products. It reported positive results from the phase II proof-of-concept clinical trial of oral enobosarm, 3 mg, in postmenopausal women with SUI. The company has initiated a second clinical trial, Assessing Enobosarm for Stress Urinary Incontinence Disorder (ASTRID): a randomized, double-blinded, placebo-controlled, phase II trial to assess the efficacy and safety of two doses of enobosarm (1 mg and 3 mg) administered orally in postmenopausal woman with SUI compared to placebo. In addition, GTx has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer. The company said it has ongoing mechanistic preclinical studies designed to select the most appropriate compound to advance into a first-in-human clinical trial.
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