Ben Schwartz is Associate Editor, Contemporary OB/GYN.
Other pipeline developments discussed in this article include the initiation of an intravesical bladder cancer study, a gel treatment for ED that has met its primary endpoint, a patent awarded for the first rechargeable implantable SNM along with some other advancements.
FDA committee votes in favor of nocturia treatment approval
The FDA Bone, Reproductive and Urologic Drugs Advisory Committee has voted 14-4 to approve the benefit-risk profile for the new drug application (NDA) of desmopressin nasal spray (SER120), submitted by Allergan plc and Serenity Pharmaceuticals, LLC. The nasal spray is an investigational drug developed for the treatment of nocturia. According to the committee, which voted 17-1 in favor, there is substantial evidence that at least one of the SER120 doses is effective. The FDA is expected to address the desmopressin nasal spray NDA in the fourth quarter of 2016.
Phase III trial of bladder Ca agent stopped after meeting endpoint
Merck has ended a phase III trial investigating the use of pembrolizumab (Keytruda) after meeting its primary endpoint of overall survival. Pembrolizumab, an anti-PD-1 therapy for patients with advanced urothelial cancer, was superior in comparison to investigator choice chemotherapy. An independent Data Monitoring Committee recommended that the trial be stopped early after a pre-specified interim analysis. Pembrolizumab is being tested in more than 360 clinical trials against more than 30 tumor types. The treatment is administered intravenously over 30 minutes every 3 weeks.
FDA approves IDE to expand study on prostate biopsy system
The FDA has approved an application for an Investigational Device Exemption submitted by Prescision Biopsy. The approval allows the company to expand its clinical trial for the ClariCore Biopsy System by allowing more prostate cancer patients to enroll in the transrectal ultrasound (TRUS) and MR/fusion arms of its study. The ClariCore system is designed to provide real-time classification of prostate tissue during biopsy procedures. The trial, which is taking place across the U.S., is expected to include 200 patients in its three arms.
Phase Ib study of intravesical bladder Ca agent initiated
Taris Biomedical recently began a phase Ib clinical trial of TAR-200 (GemRIS, Gemcitabine Releasing Intravesical System) in patients with nonmuscle-invasive bladder cancer (NMIBC). The study is the second phase Ib trial of the drug device system. It will assess whether or not continuous, local exposure to gemcitabine using TAR-200 is safe in patients with intermediate-risk NMIBC. The study will be conducted at multiple sites throughout Europe and expects to have 30 patients who have been diagnosed with NMIBC but have not yet had a transurethral resection of bladder tumors. TARIS also began a study in muscle-invasive bladder cancer in July 2016.
Phase III RCC study compares levatinib combinations vs. sunitinib
Eisai Inc. has initiated a multicenter, global, randomized phase III study evaluating the efficacy and safety of two regimens containing levatinib (Lenvima), a multiple receptor tyrosine kinase inhibitor. The study will compare levatinib in combination with pembrolizumab (Keytruda) and levatinib in combination with everolimus (Len+Eve), against sunitinib, the current standard of care for patients with advanced renal cell carcinoma in the first-line setting. This is the first phase III trial to assess the effectiveness of both combinations. The study aims to enroll 735 patients with advanced RCC who have not received any previous systemic therapy. Patients will be randomized 1:1:1 to receive either levatinib plus pembrolizumab, levatinib plus everolimus, or sunitinib.
Study: Gel treatment for erectile dysfunction meets primary endpoint
Futura Medical plc has released results from its efficacy study of MED2002, a gel for the treatment of erectile dysfunction. MED2002 has reached its primary endpoint and has successfully demonstrated efficacy, safety, and speed in which the gel takes effect, Futura said. The study, comprised of 232 randomized males with mild to severe ED, measured improvement in the erectile function (EF) domain score of the International Index of Erectile Function. The study consisted of placebo-controlled, double blind, home use, and crossover design. It achieved its primary endpoint, with the MED2002 group showing statistically significant improvement in erectile function (p=.0132) in the EF domain score when compared with placebo. Eighty-two percent of patients with mild ED had an onset of action within 10 minutes, and in 54% of mild ED patients, onset of action occurred within 5 minutes. No major safety concerns were identified during the study.
Patent awarded for first rechargeable implantable SNM
Axonics Modulation Technologies, Inc. has been granted a U.S. patent for developing the first rechargeable implantable sacral neuromodulation system for the treatment of urinary and fecal dysfunction. The patent covers helical anchoring devices with a plurality of tines that engage tissue to inhibit migration of an implanted lead of a neuromodulation system. Axonics is currently carrying out a post-market study in select centers around Europe.
FDA accepts application for advanced bladder cancer agent
The FDA has accepted a supplemental Biologics License Application (sBLA) submitted by Bristol-Myers Squibb for priority review to expand the use of nivulomab (Opdivo). The sBLA focuses on nivulomab as treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. The drug was granted Breakthrough Therapy Designation for mUC in June 2016. The submission was based on data from a phase II, single-arm clinical trial that evaluated the safety and efficacy of nivulomab in 270 patients with unresectable or astatic urothelial carcinoma that did not see positive results following a treatment with a platinum-based agent. The study’s endpoints included confirmed objective response rate, as well as progression-free survival, overall survival, and quality of life. The FDA action date is March 2, 2017.
Data released on checkpoint inhibitor’s use in certain cancers
Corvus Pharmaceuticals, Inc. announced preclinical data and preliminary biomarker data from an ongoing phase I/phase Ib study of CPI-444 as a single agent and in combination with atezolizumab (Tecentriq). Preliminary data from the study shows a complete blockade of peripheral blood lymphocyte A2A receptors in a dose-dependent manner and induction of activated t-cells. The trial is designed to study the effects of using CPI-444 both as a single agent and in combination with atezolizumab. The first part of the study includes four groups of 12 patients each. Three groups are treated with CPI-444 on its own while the last group is treated with the combination. Preliminary data demonstrated that 40%-100% blockade of peripheral blood lymphocyte A2A receptors was achieved in a dose-dependent manner in the first 11 patients treated. CPI-444 has been shown to be active in generating anti-tumor immunity, suppressing tumor growth, and stimulating various immune cells. Patients with renal cell cancer, bladder cancer, and prostate cancer who have failed all standard therapies are among those eligible for the phase I/phase Ib trial.
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