A new Phase 1b clinical trial will evaluate if combining TAR-200 (GemRIS), a chemotherapy-releasing agent, and Opdivo (nivolumab) is a safe, well tolerated, and efficacious approach for the treatment of muscle invasive bladder cancer.
This trial will enroll participants whose bladder cancer has spread into the muscle layer of the bladder and who are scheduled for bladder removal surgery. It is part of a collaboration between TARIS Biomedical and Bristol Myers Squibb.
“This is the first study evaluating the potential benefits of combining TAR-200 with a systemically administered immune checkpoint inhibitor,” Purnanand Sarma, PhD, president and CEO of TARIS, said in a press release. Muscle invasive bladder cancer “is a potentially lethal disease with high unmet clinical need. We are excited to partner with Bristol-Myers Squibb, a world-leader in oncology, to advance approaches that may provide meaningful benefit to patients.”
TAR-200 is a drug-device product that releases the chemotherapeutic drug gemcitabine continuously in the bladder over seven days.
The approach makes use of the TARIS system, a small tube-like device that contains a drug in its core and releases it over weeks or months in a controlled manner. The technology helps control the drug’s release rates to match the requirements of specific treatment regimens.
The system is placed into and removed from the bladder using minimally invasive in-office procedures.
“We continue to explore multiple approaches to treating cancer as part of our broad research program focused on delivering the next wave of oncology therapies,” said Fouad Namouni, MD, head of development, Oncology, at Bristol-Myers Squibb. “Partnering with TARIS will allow us to advance our scientific understanding of combining Opdivo with continuous local chemotherapy as we seek to improve outcomes for patients with this aggressive form of bladder cancer.”
TAR-200 is currently being tested in an open-label Phase 1b study (NCT02722538) on patients with muscle invasive bladder cancer. The trial was designed to include 20 participants from three clinical sites in the United States, who had bulky residual tumors after surgical removal of the primary tumor.
In the study, TAR-200 was placed inside the bladder at days 1 and 21, where it released gemcitabine during the following seven days. The placements were performed in the 28-day window between the surgical tumor resection procedures.
Preliminary data released in January 2017 revealed that the system was well tolerated over the two, seven-day treatment periods, with no significant tolerability issues reported. Also, TAR-200 promoted significant tumor shrinkage responses in eight of 10 patients.