In the majority of cases, the cancer disappeared after only three months of treatment, and almost half the patients were cancer-free a year later. 

“Traditionally, these patients have had very limited treatment options. This new therapy is the most effective one reported to date for the most common form of bladder cancer,” said Sia Daneshmand, MD, director of urologic oncology with Keck Medicine of USC and lead author of a study detailing the clinical trial results published in the Journal of Clinical Oncology. “The findings of the clinical trial are a breakthrough in how certain types of bladder cancer might be treated, leading to improved outcomes and saved lives.” 

How the drug delivery system works  

TAR-200 is a miniature, pretzel-shaped drug-device duo containing a chemotherapy drug, gemcitabine, which is inserted into the bladder through a catheter. Once inside the bladder, the TAR-200 slowly and consistently releases the gemcitabine into the organ for three weeks per treatment cycle.  

Traditionally, gemcitabine has been delivered to the bladder as a liquid solution that only stays in the bladder for a few hours, which had limited effect destroying the cancer, said Daneshmand, who is also a member of the USC Norris Comprehensive Cancer Center. 

“The theory behind this study was that the longer the medicine sits inside the bladder, the more deeply it would penetrate the bladder and the more cancer it would destroy,” he said. “And it appears that having the chemotherapy released slowly over weeks rather than in just a few hours is a much more effective approach.” 

The patient population in the clinical trial  

The clinical trial, known as the SunRISe-1, was conducted at 144 locations globally, including at Keck Hospital of USC. It included 85 patients with high-risk non-muscle-invasive bladder cancer.  

Non-muscle-invasive bladder cancer is the most common form of bladder cancer. The disease is considered high risk when, depending on the type and location of the tumors, the cancer carries a higher chance of recurrence and/or spreading to the bladder muscles or other parts of the body. 

The standard treatment for this type of bladder cancer is an immunotherapy drug, Bacillus Calmette-Guérin, which may be ineffective in a percentage of patients. All the patients in the clinical trial had been previously treated with this drug, but their cancer had returned.  

“The standard treatment plan for these patients was surgery to remove the bladder and surrounding tissue and organs, which has many health risks and may negatively impact patients’ quality of life,” said Daneshmand. 

To offer patients a better option, urologic oncologists treated patients with TAR-200 every three weeks for six months, and then four times a year for the next two years. In 70 out of 85 patients, the cancer disappeared and for almost half the patients, was still gone a year later. The treatment was well-tolerated, with minimal side effects.  

The study also showed that administering TAR-200 along with another immunotherapy drug (cetrelimab) did not prove as effective as TAR-200 on its own 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-release cancer drugs  

This clinical trial is one of several ongoing ones investigating the effect of TAR-200 and the slow release of cancer-fighting drugs into the bladder to fight cancer.  

“We are at an exciting moment in history,” said Daneshmand, who has been researching this novel treatment since 2016. “Our mission is to deliver cancer-fighting medications into the bladder that will offer lasting remission from cancer, and it looks like we are well on our way toward that goal.”  

The U.S. Food and Drug Administration has granted TAR-200 a New Drug Application Priority Review, which means the FDA plans to take quicker action on the application than other applications. 

The health care corporation Johnson & Johnson manufactures TAR-200.

LOS ANGELES - Surgeons from Keck Medicine of USC and UCLA Health have performed the world's first-in-human bladder transplant. The surgery was successfully completed at Ronald Reagan UCLA Medical Center on May 4, 2025, in a joint effort by Inderbir Gill, MD, founding executive director of USC Urology, and Nima Nassiri, MD, urologic transplant surgeon and director of the UCLA Vascularized Composite Bladder Allograft Transplant Program.

Groundbreaking moment in medical history 

"This surgery is a historic moment in medicine and stands to impact how we manage carefully selected patients with highly symptomatic 'terminal' bladders that are no longer functioning," said Gill, who is also Chair and Distinguished Professor of Urology and Shirley and Donald Skinner Chair in Urologic Cancer Surgery with the Keck School of Medicine of USC. "Transplantation is a lifesaving and life-enhancing treatment option for many conditions affecting major organs, and now the bladder can be added to the list."

"This first attempt at bladder transplantation has been over four years in the making," Nassiri said. "For the appropriately selected patient, it is exciting to be able to offer a new potential option."

Nassiri, formerly a urology resident with the Keck School and now assistant professor of urology and kidney transplantation at UCLA, and Gill worked together for several years at the Keck School to develop the new surgical technique, design a clinical trial and secure the necessary regulatory approvals.

Numerous pre-clinical procedures were performed both at Keck Medical Center of USC and OneLegacy, Southern California's organ procurement organization, to prepare for this first-in-human bladder transplant.

A complicated yet successful surgery 

The patient had been dialysis-dependent for seven years. He lost the majority of his bladder during surgery to resect cancer over five years ago, leaving the remainder of his bladder too small and compromised to function appropriately. Both of his kidneys were subsequently removed due to renal cancer.

To address these deficits, Drs. Gill and Nassiri performed a combined kidney and bladder transplant, allowing the patient to immediately stop dialysis and produce urine for the first time in seven years. First the kidney, then the bladder, were transplanted. The new kidney was then connected to the new bladder. The entire procedure took approximately eight hours.

"The kidney immediately made a large volume of urine, and the patient's kidney function improved immediately," Nassiri added. "There was no need for any dialysis after surgery, and the urine drained properly into the new bladder."

"Despite the complexity of the case, everything went according to plan and the surgery was successful," said Gill. "The patient is doing well, and we are satisfied with his clinical progress to date."

The recovery of the kidney and bladder from the donor was performed at OneLegacy's Transplant Recovery Center in Azusa, Calif. All parts of the procedure, including surgery and post-surgical monitoring during the transplantation, were aligned with the highest current clinical and research standards.

How a bladder transplant may benefit patients

Millions of people around the globe experience some degree of bladder disease and dysfunction. Some develop terminal bladders that are either non-functioning and/or cause constant pain, repeated infections and other complications. Current treatment for severe terminal cases of bladder dysfunction or a bladder that has been removed due to various conditions includes replacement or augmentation of the urinary reservoir. These surgeries use a portion of a patient's intestine to create a new bladder or a pathway for the urine to exit the body.

"While these surgeries can be effective, they come with many short-and long-term risks that compromise a patient's health such as recurrent infections, compromised kidney function and digestive issues," said Gill.

"A bladder transplant, on the other hand, delivers a more 'normal' urinary reservoir and may circumvent some of the challenges associated with using the intestine," said Nassiri.

The biggest risks of organ transplant are the body's potential rejection of the organ and side-effects caused by the mandatory immunosuppressive drugs given to prevent organ rejection.

"Because of the need for long-term immunosuppression, the best current candidates are those with a pre-existing organ transplant or those who need a combined kidney and bladder transplant," said Nassiri.

As a first-in-human attempt, there are naturally many unknowns associated with the procedure, such as how well the transplanted bladder will function immediately and over time, and how much immunosuppression will ultimately be needed.

"Despite the unknowns, our goal is to understand if bladder transplantation can help patients with severely compromised bladders lead healthier lives," said Gill.

Collaborative research and development leading to the transplant 

Bladder transplants have not been done previously, in part because of the complicated vascular structure of the pelvic area and the technical complexity of the procedure. As part of the research and development stage, Gill and Nassiri successfully completed numerous practice transplantation surgeries at Keck Medical Center of USC, including the first-ever robotic bladder retrievals and successful robotic transplantations in five recently deceased donors with cardiac function maintained on ventilator support.

Several non-robotic trial runs of bladder recovery were performed at OneLegacy by Gill and Nassiri, allowing them to perfect the technique while working alongside multidisciplinary surgical teams.

The bladder transplant was done as part of a UCLA clinical trial. Gill and Nassiri hope to perform more bladder transplants together in the near future.

Under Gill's leadership, USC Urology has rapidly established itself as a pioneer and world leader in the most advanced robotic urologic oncologic surgeries for kidney, bladder, prostate, testicular and penile cancers, and has achieved important milestones leveraging machine learning and artificial intelligence to optimize patient outcomes.

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