Uro Pipeline: FDA accepts two supplemental applications for mUC agent

April 6, 2017

Other pipeline developments include efficacy results for a bladder and prostate cancer drug, an infertility tool to predict sperm quality, the initiation of an immunotherapy combination for mUC, and more.

FDA accepts two supplemental applications for mUC agent

The FDA has accepted for review two supplemental Biologics License Applications for Merck’s pembrolizumab (Keytruda). The drug is an anti-PD-1 therapy for patients with locally advanced or metastatic urothelial cancer (mUC). The application Merck submitted for first-line use was accepted and granted Priority Review for mUC patients who are ineligible to receive cisplatin-containing therapy. The Prescription Drug User Fee Act target action date for both applications is June 14, 2017. Both applications are based on results from a phase II and phase III study and are seeking approval for pembrolizumab monotherapy at an intravenously administered dose of 200 mg every 3 weeks.

 

GnRH antagonist for prostate cancer moves into phase III study

Myovant Sciences has begun a phase III clinical trial to evaluate the safety and efficacy of relugolix in the treatment of advanced prostate cancer. The drug is a once-daily, oral gonadotropin-releasing hormone receptor antagonist that reduces testosterone levels by inhibiting pituitary release of luteinizing hormone and follicle stimulating hormone. The study is a randomized, parallel-group international clinical trial that has enrolled approximately 1,125 patients. Patients will be randomized 2:1 to receive either relugolix, 120 mg once daily, or leuprolide acetate 3-month depot injection, respectively. The primary efficacy outcome is for relugolix to reach and maintain testosterone suppression levels equal to castrate levels (£50 ng/dL) for 48 weeks.

Next: Phase II data suggest drug's efficacy in bladder, prostate Ca

 

Phase II data suggest drug’s efficacy in bladder, prostate Ca

Two phase II studies demonstrated that apatorsen improved outcomes in bladder and prostate cancer patients when administered in combination with docetaxel and abiraterone acetate (Zytiga). OncoGenex Pharmaceuticals announced the results at the Genitourinary Cancers Symposium in Orlando, FL. The Borealis-2 trial evaluated apatorsen in combination with docetaxel treatment in 200 metastatic bladder cancer patients who did not respond to platinum-based chemotherapy. Patients who received the combination treatment experienced a 20% reduction in risk of death and also saw higher response durations compared to those receiving docetaxel alone. The Pacific trial evaluated the ability of apatorsen, in combination with abiraterone, to reverse or delay treatment resistance in 72 men whose PSA rose when taking abiraterone acetate alone. The primary endpoint assessed the percentage of patients who were progression free at study day 60 using the combination therapy compared to abiraterone on its own. In men receiving the combination therapy, 33% were progression free at the endpoint compared to 17% receiving abiraterone alone.

 

FDA accepts biologics license application for mUC treatment

The FDA has accepted for priority review EMD Serono’s Biologics License Application for avelumab as a treatment for metastatic urothelial carcinoma. Avelumab has been given a Prescription Drug User Fee Act target action date of August 27, 2017. The Priority Review status reduces the review time from 10 months to 6 months from the day of filing. The drug is an investigational, fully human anti-PD-L1 antibody and has been involved in at least 30 international clinical programs, including nine phase III trials. Avelumab received priority review status in November 2016 for the treatment of metastatic Merkel cell carcinoma.

Next: Combination RCC treatment yields positive phase II results

 

Combination RCC treatment yields positive phase II results

Roche has announced positive results from a phase II study that compared atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) and atezolizumab monotherapy in comparison to sunitinib (Sutent) alone in people with untreated metastatic renal cell carcinoma (RCC). The global, multicenter, open-label, randomized phase II study found that treatment with atezolizumab plus bevacizumab led to a 36% reduction in disease progression or death compared to sunitinib monotherapy. The study included 305 metastatic RCC patients who had been previously untreated. Separately, Roche is involved with a phase III study evaluating atezolizumab in combination with bevacizumab against sunitinib in patients with previously untreated metastatic RCC.

 

Infertility tool found accurate for predicting sperm quality

Aytu Bioscience has announced the publication of a study demonstrating the clinical utility of the company's MiOXSYS System for assessing the level of oxidative stress in semen as an aid in the diagnosis of infertility in men. The article appears online in Urology ahead of print. The MiOXSYS System measures oxidation-reduction potential (ORP), which comprehensively measures oxidative stress by simultaneously accounting for all the known and unknown oxidants and antioxidants in the semen sample. Results of the study established oxidative stress as a key mechanism in patients suffering from oligozoospermia and that ORP can serve as an indicator of sperm quality over time. Aytu has obtained CE marking for commercialization in Europe, but is currently pursuing an FDA clearance pathway in the United States.

Next: Study to examine effects of vaccine/immunotherapy combo in mUC

 

Study to examine effects of vaccine/immunotherapy combo in mUC

Bavarian Nordic and Roche have reached an agreement in which Roche will supply its PD-L1 blocking antibody, atezolizumab (Tecentriq) for a clinical study involving the use of atezolizumab in combination with CV301, Bavarian Nordic’s cancer vaccine. The study will examine the effects on patients with locally advanced or metastatic urothelial carcinoma and have had disease progression during or following platinum-containing chemotherapy. The phase II study will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer vaccine could be synergistic by enhancing the patient’s immune response. Under the agreement, Roche will supply atezolizumab for the study and Bavarian Nordic is responsible for conducting the study, but both companies with share data from the trial.

 

Study initiated to examine utility of genomic test in prostate Ca treatment decisions

GenomeDx Biosciences has begun a prospective, randomized controlled trial to evaluate the utility of Decipher Prostate Cancer Classifier, a commercially available genomic test. The test examines gene activity in prostate cancer cells in order to predict whether or not a patient’s cancer will metastasize. The study, known as the Genomics in Michigan Impacting Observation or Radiation (G-MINOR) trial, is being conducted by the Michigan Urological Surgery Improvement Collaborative (MUSIC). The primary endpoint of the study is to determine the degree to which Decipher may help decide if additional radiation treatment is needed after prostate surgery. The collected data from the study will be added to GenomeDx’s genomic expression database, Decipher GRID. The study is open to men with a high risk of cancer recurrence who have undergone a radical prostatectomy at a participating MUSIC site within the past year.

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