Novel Drug in Bladder Cancer Enters Phase III Trial

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

References

1. Investor.sppirx.com. Spectrum Pharmaceuticals initiates apaziquone pivotal trial for the treatment of non-muscle invasive bladder cancer (NMIBC) following SPA agreement (NASDAQ:SPPI). http://investor.sppirx.com/releasedetail.cfm?ReleaseID=938282. Accessed October 28, 2015.
2. Seeking Alpha. Spectrum pharma initiates late-state study of apaziquone for bladder cancer. http://seekingalpha.com/news/2856336-spectrum-pharma-initiates-late-state-study-of-apaziquone-for-bladder-cancer. Accessed October 29, 2015.