A new drug release system, Tar-200, has eliminated tumors in 82% of patients from a phase 2 clinical trial for people with high-risk non-invasive bladder cancer whose cancer had already resisted the treatment.
In the majority of cases, cancer disappeared after only three months of treatment, and almost half of the patients were cancer without a year later.
Traditionally, these patients have had very limited treatment options. This new therapy is the most effective reported to date for the most common form of bladder cancer. The results of the clinical trial are a breakthrough in the way certain types of bladder cancer could be treated, leading to better results and save lives. »»
Sia Danshmand, MD, director of urological oncology with Keck Medicine of USC and principal author of a study detailing the results of clinical trials published in the Journal of Clinical ONCOLOGY
How the drug administration system works
Tar-200 is a miniature duo in the shape of a Bretzel-shaped medication containing a chemotherapy medication, the gemcitabine, which is inserted in the bladder through a catheter. Once inside the bladder, the Tar-200 slowly and regularly releases the gemcitabine in the organ for three weeks by treatment cycle.
Traditionally, gemcitabine has been delivered to the bladder as a liquid solution which remains only in the bladder for a few hours, which had a limited effect to destroy cancer, said Danehmand, which is also a member of the complete Cancer of the USC Norris cancer.
“The theory behind this study was that the more the drug is inside the bladder, the more deeply it penetrated the bladder and the more cancer it would,” he said. “And it seems that the release of chemotherapy slowly over the weeks rather than in a few hours is a much more effective approach. »»
The population of patients in the clinical trial
The clinical trial, known as Sunrise-1, was led to 144 places around the world, including at KECK Hospital in the USC. It included 85 patients with non -high -risk non -invasive bladder cancer.
Non -muscular non -invasive bladder cancer is the most common form of bladder cancer. The disease is considered to be a high risk when, depending on the type and location of tumors, cancer is more likely for recurrence and / or propagation to the bladder muscles or other parts of the body.
The standard treatment of this type of bladder cancer is an immunotherapy medication, Bacillus Calmette-Guérin, which can be ineffective in a percentage of patients. All clinical trial patients had already been treated with this medication, but their cancer had returned.
“The standard treatment plan for these patients was surgery to eliminate the bladder and the surrounding tissues and organs, which has many health risks and can have a negative impact on the quality of life of patients,” said Danehmand.
To offer patients a better option, urological oncologists have treated patients with Tar-200 every three weeks for six months, then four times a year for the next two years. In 70 of the 85 patients, cancer has disappeared and for almost half of the patients, it had always disappeared a year later. The treatment was well tolerated, with a minimum of side effects.
The study also showed that the administration of Tar-200 with another immunotherapy medication (Cetrelimab) has not proven to be as effective as Tar-200 in itself and had more side effects.
While participants in the clinical trial will be followed for another year, the study is closed to new participants.
The future of slow liberation cancer drugs
This clinical trial is one of the many in progress on the effect of Tar-200 and the slow release of cancer drugs in the bladder to fight cancer.
“We are at a fascinating moment in history,” said Danshmand, who has been researching this new treatment since 2016. “Our mission is to provide cancer drugs in the bladder that will offer a sustainable cancer remission, and it seems that we are on the right track towards this objective. »»
The Food and Drug Administration of the United States has granted Tar-200 a new examination of the priority of the demand for medication, which means that the FDA plans to take faster measures at the request than other requests.
The health care company Johnson & Johnson manufactures Tar-200.
