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Agents for bladder cancer, overactive bladder, and hyperoxaluria are among the other products discussed in this round-up.
Patient enrollment begins for PCa immunotherapy trial
Dendreon Pharmaceuticals LLC has begun enrolling patients in the ProVent clinical trial, which is evaluating the effectiveness of sipuleucel-T (PROVENGE) in reducing disease progression in men with prostate cancer on active surveillance (AS). Sipuleucel-T remains the only FDA-approved immunotherapy proven to extend overall survival in metastatic castrate-resistant prostate cancer, and data from two previous studies (NeoACT, STAND) in non-metastatic disease provide strong scientific rationale for evaluating the use of sipuleucel-T in men on AS, according to Dendreon. ProVent is currently enrolling patients at approximately 50 sites across the U.S.
Complete-response data reported for urothelial cancer agent
UroGen Pharma Ltd. announced topline results from the ongoing pivotal phase III OLYMPUS clinical trial of mitomycin gel (UGN-101) for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (LG UTUC). This analysis showed that on an intent-to-treat basis, 57% of patients achieved a complete response (CR) rate at their primary disease evaluation (the primary endpoint), which was conducted 4 to 6 weeks after completion of UGN-101 treatment. All evaluated patients in CR remain disease free at 6 months. UroGen said it intends to seek regulatory approval of UGN-101 in LG UTUC based on data from all 71 patients and initiated its rolling submission of the New Drug Application to the FDA in December 2018. UroGen previously announced that it has initiated the rolling submission with the FDA of the NDA for UGN-101 for instillation as a treatment for patients with LG UTUC. The company expects to complete its NDA submission by mid-2019, with potential approval in 2019.
Randomized trial launched for stress incontinence device
Renovia Inc. recently launched a large, multicenter randomized controlled trial to study the efficacy of a first-line non-surgical digital therapeutic for the treatment of stress-dominant urinary incontinence. Renovia’s next-generation leva Pelvic Digital Therapeutic System allows women to have real-time visual verification they are performing their pelvic floor muscle exercises (PFME) correctly and consistently by guiding women through pelvic floor muscle treatment. The study seeks to determine whether home use of the device leads to more significant improvements in pelvic floor muscle performance than a PFME program without leva and improves adherence to a long-term maintenance program of home PFME.
Trial of NMIBC agent yields positive 12-month results
Sesen Bio, Inc. reported positive preliminary efficacy data for the primary endpoint of its ongoing phase III VISTA registration trial of VB4-845 (Vicinium) for the treatment of patients with high-grade nonmuscle-invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-GuÃ©rin (BCG) and deemed BCG unresponsive. The data show clinically meaningful complete response rates in evaluable carcinoma in situ patients at 3, 6, 9, and 12 months of follow-up in the trial consistent with the data in the completed phase I and phase II clinical trials. The agent continues to be generally well tolerated, Sesen Bio reported.
Next: Early results for urothelial Ca test show 100% sensitivityEarly results for urothelial Ca test show 100% sensitivity
Nucleix Ltd. announced preliminary results from an ongoing prospective, single-center study, indicating the effectiveness of its Bladder EpiCheck urine test in detecting upper tract urothelial carcinoma (UTUC). The data were published in the World Journal of Urology (Jan. 2, 2019 [Epub ahead of print]). Bladder EpiCheck is already CE approved for monitoring bladder cancer, and the new study will evaluate its potential role in the diagnosis and surveillance of UTUC. The trial is a prospective, single-center study that will include 80 patients with suspected primary or recurrent UTUC. Urine samples from the bladder and the upper urinary tract will be collected by ureteroscopy and will be analyzed by both EpiCheck and urinary cytology. Primary endpoints include assessment of sensitivity, specificity, and positive and negative predictive values, in high- and low-grade tumors, as well as comparison with cytology. Preliminary results from urine samples of six patients demonstrated 100% sensitivity in high-grade UTUC patients and specificity of 100%, correctly identifying the healthy patient.
metastatic CRPC agent shows positive results in phase II trial
Clovis Oncology, Inc. announced initial data from its ongoing phase II TRITON2 clinical trial of rucaparib (Rubraca) for metastatic castration-resistant prostate cancer at the 2018 European Society for Medical Oncology annual congress in Munich. The data show a 44% confirmed objective response rate by investigator assessment in 25 RECIST/PCWG3 response-evaluable patients with a BRCA1/2 alteration. The median duration of response in these patients has not yet been reached. A 51% confirmed PSA response rate was observed in 45 PSA response-evaluable patients with a BRCA1/2 alteration. The TRITON2 results were the basis for Breakthrough Therapy designation for rucaparib (granted Oct. 2, 2018) as a monotherapy treatment of adult patients with BRCA1/2 mutated metastatic castration-resistant prostate cancer who have received at least one prior androgen receptor-directed therapy and taxane-based chemotherapy.
Study of urothelial cancer agent completes enrollment
Seattle Genetics, Inc. and Astellas Pharma Inc. have completed enrollment for the enfortumab vedotin EV-201 pivotal phase II clinical trial cohort of patients with locally advanced or metastatic urothelial cancer who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1). Enfortumab vedotin is an investigational antibody-drug conjugate that targets Nectin-4. The companies say they expect to report topline efficacy and safety results from this first cohort of the EV-201 trial, which is intended to support potential registration under the FDA’s accelerated approval pathway, in the first half of 2019. The companies also announced dosing of the first patient in EV-301, a global, randomized phase III clinical trial evaluating enfortumab vedotin in patients with previously treated locally advanced or metastatic urothelial cancer. The EV-301 trial is intended to support a broader global registration strategy and to serve as the confirmatory randomized trial in the U.S. for EV-201. Enfortumab vedotin has been granted Breakthrough Therapy Designation by the FDA for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
Enrollment completed for phase III trial of overactive bladder drug
Urovant Sciences has completed enrollment in its international phase III clinical trial, EMPOWUR, evaluating the safety and efficacy of vibegron as a treatment for adults with symptoms of overactive bladder. Vibegron is an investigational oral beta-3 adrenergic agonist. EMPOWUR is a randomized, double-blind placebo- and active comparator-controlled clinical trial in men and women with symptoms of OAB, including frequent urination, sudden urge to urinate, and urge incontinence or leakage. Co-primary endpoints are change from baseline in the average number of micturitions per 24 hours in all patients and change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients who have one or more UUI episodes per day prior to treatment.
Next - Phase IIb data: Localized prostate Ca agent safe, well toleratedPhase IIb data: Localized prostate Ca agent safe, well tolerated
Sophiris Bio Inc. recently provided an update from its phase IIb study of topsalysin for localized prostate cancer, including top-line safety and biopsy results from the patients who received a second administration of study drug, which appeared to be safe and generally well tolerated. Additional benefit was not observed on targeted biopsy 6 months after re-treatment with a second administration of topsalysin. As previously stated, 27% of patients (10/37) demonstrated a clinical response 6 months following a single administration of topsalysin. Six of the 10 clinical responders experienced complete ablation of their tumor. Based on these results, Sophiris Bio said it is moving forward with plans to propose a single phase III registration trial design using a single administration of topsalysin, which it will discuss with regulatory agencies in the coming months.
FDA alignment reached on phase III trial of hyperoxaluria therapy
Allena Pharmaceuticals, Inc. has reached alignment with the FDA on both the design of URIROX-2, its second pivotal phase III trial of reloxaliase in patients with enteric hyperoxaluria, and its strategy to pursue a Biologics License Application submission for reloxaliase using the accelerated approval regulatory pathway. Allena’s URIROX program consists of two pivotal phase III clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria. URIROX-1 is currently enrolling patients, and Allena initiated URIROX-2 in the fourth quarter of 2018. The primary efficacy endpoint for URIROX-2 is the percent change from baseline in 24-hour urinary oxalate excretion measured during weeks 1-4, the same primary efficacy endpoint as URIROX-1.
Prostate Ca test to be developed on PCR-based platform
Genomic Health, Inc. and BiocartisGroup NV have expanded their exclusive collaboration into the field of urology with the development of an in vitro diagnostic version of the Oncotype DX Genomic Prostate Score (GPS) test on Biocartis’ Idylla platform and potentially additional cancer tests that can be performed locally by laboratory partners and in hospitals around the world. The Idylla Oncotype DX GPS test will be the first urology test to be developed on Biocartis’ fully automated, polymerase chain reaction-based Idylla platform, which offers a unique sample-to-result molecular diagnostics solution.
Positive preliminary phase III data reported for bladder cancer agent
Sesen Bio, Inc. reported positive preliminary efficacy data for the primary endpoint of its ongoing phase III registration trial, the VISTA Trial, of Vicinium for the treatment of patients with high-grade nonmuscle-invasive bladder cancer who have been previously treated with bacillus Calmette-GuÃ©rin (BCG) and deemed BCG-unresponsive. The data showed clinically meaningful complete response rates in evaluable carcinoma in situ patients at 3, 6, 9, and 12 months of follow-up in the trial consistent with the data in the completed phase I and phase II clinical trials. The agent continues to be generally well tolerated in treated patients.