In this installment of "Product Preview," also look for information on products in the pipeline for renal cell carcinoma and interstitial cystitis.
Spectrum Pharmaceuticals, Inc. has reached agreement with the FDA on the special protocol assessment (SPA) of the planned phase III clinical trial of its novel, potent pro-drug apaziquone. The trial will further evaluate the intravesical use of apaziquone for the treatment of patients with nonmuscle-invasive bladder cancer (NMIBC) as one or two instillations, immediately following transurethral resection of bladder tumor. In accordance with the SPA, the phase III trial will be a randomized, double-blind, placebo-controlled, multicenter trial that will enroll patients with TaG1 or G2 NMIBC. The primary endpoint is time to recurrence.
An open-label, randomized phase III study evaluating nivolumab (Opdivo) versus everolimus (Afinitor) in previously treated patients with advanced or metastatic renal cell carcinoma was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving nivolumab compared to the control arm. Bristol-Myers Squibb says it is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with nivolumab in an open-label extension.
MDxHealth SA recently announced positive top-line data for its “liquid biopsy” test for bladder cancer. Preliminary data from a cohort of 154 patients with hematuria, due to be presented at the World Congress on Urological Research in Nijmegen, the Netherlands, show that the liquid biopsy urine test for bladder cancer had a negative predictive value of 98.3%, the company reported.
The FDA has granted the multiple receptor tyrosine kinase inhibitor lenvatinib breakthrough therapy designation for the investigational use in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor-targeted therapy. Lenvatinib, marketed under the brand name LENVIMA, is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvatinib is not indicated for patients with metastatic renal cell carcinoma, said manufacturer Elsai Inc.
Aquinox Pharmaceuticals, Inc. recently announced results from secondary endpoints from its phase II LEADERSHIP trial with AQX-1125 in patients with bladder pain syndrome/interstitial cystitis (BPS/IC). Positive results from secondary endpoints, which included a statistically significant 1.3-point greater reduction over placebo on maximum daily pain at 6 weeks (p=.030) and a statistically significant 4.4-point greater reduction over placebo on the O’Leary-Sant Symptom Index at 6 weeks compared to placebo (p=.008), support further development of AQX-1125 in BPS/IC, Aquinox reported.
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