Researchers are investigating apaziquone for use as an intravesical treatment for patients with nonmuscle-invasive bladder cancer.
bladder cancer
Rajesh Shrotriya, MD
Researchers are investigating apaziquoneits, a novel, potent-pro drug, for use as an intravesical treatment for patients with nonmuscle-invasive bladder cancer (NMIBC) with a phase III trial.1
The phase III trial began on October 23, 2015, when Spectrum Pharmaceuticals, Inc administered apaziquoneits to its first patient. Previous phase III trial findings and FDA recommendations have guided research for this next set of clinical trials to improve study outcomes. In these previous studies, researchers observed significant reduction in 2-year recurrence rates and a positive safety profile. The recorded data of prior phase III trials forms the basis of the NDA and puts the company on track to submit their filings to the FDA before the end of the year.
According to Rajesh C. Shrotriya, MD, chairman and CEO of Spectrum Pharmaceuticals, the overall cost of treatments for bladder cancer in the United States averages about $3.4 billion per year, most of which is due to the high frequencies of recurrence.
"Apaziquone has the potential to usher in an importantly needed paradigm shift in the treatment of NMIBC, as the first new drug in its indication in over 40 years," said Shrotriya.1
Apaziquone is activated by bio-reductive enzymes present in bladder cancer cells, which renders the drug a highly cytotoxic alkylating agent.2Researchers aim to use this novel drug as a means of addressing the unmet medical needs for patients with NMIBC.1
The randomized, double-blind, placebo-controlled, multicenter trial will recruit patients with Ta, G1-G2 NMIBC.1Administration will occur immediately following transurethral resection of bladder tumors (TURBT). In the first arm patients receive 1 installation of apaziquone, arm 2 will receive 2 installations of apaziquone, and arm 3 will receive placebo.
Researchers have made an adjustment to the clinical trial’s procedure following data from prior trials: the new protocol requires that patients receive their apaziquone dosage within 30 to 90 minutes post-TURBT, because researchers have found that apaziquone inactivates in the presence of blood.
Lawrence Karsh, MD, FACS, director of research at The Urology Center of Colorado, explained in a statement that scientific data emphasizes the importance of introducing a chemotherapeutic agent post-TURBT but that no drug or therapy exists in the United States that is approved for use in patients with NMIBC.1
Bladder cancer is the fifth most common malignancy in the United States and nearly 74,000 new cases will be diagnosed in 2015. Karsh stressed that the implementation of a new therapy such as apaziquone has the potential to meet patient’s unmet medical needs, offer a new course of treatment, and reduce healthcare costs linked to treatment for patients with NMIBC.1
Responders to UGN-101 Have Positive RFS in Upper Tract Urothelial Cancer
May 5th 2024In patients at 15 centers who had upper tract urothelial cancer, those with no evidence of disease after UGN-101 induction had a 68% rate of 3-year recurrence-free survival, and this outcome did not differ based on tumor status, method of instillation, or treatment intent.
Read More
UGN-101 Shows Promise for Upper Tract Urothelial Cancer Durability
May 5th 2024Maintenance UGN-101 therapy demonstrated good durability of response in initial responders with low-grade upper tract urothelial cancer, as evidenced by a low rate of disease progression in a multicenter, longitudinal follow-up study.
Read More
Nivolumab With Gemcitabine-Cisplatin Boosts Survival in Metastatic Urothelial Carcinoma
May 5th 2024Combination therapy with nivolumab and gemcitabine-cisplatin showed promising results in treating metastatic urothelial carcinoma with significantly improved overall survival and progression-free survival rates.
Read More