Lei Lei Wu
News Reporter
In an early cut of data, Johnson & Johnson said Sunday afternoon that seven of eight bladder cancer patients who received its experimental bladder cancer treatment — a decades-old chemotherapy delivered in a device which its developers call “the pretzel” — saw their tumors go away.
The Phase II study, known as SunRISe-1, looked at patients with non–muscle-invasive bladder cancer (meaning that their cancer has not infiltrated their bladder wall) who did not respond to Bacillus Calmette-Guérin, or BCG, the standard-of-care treatment.
These data, presented at the American Urological Association meeting in Chicago over the weekend, included eight patients who got “the pretzel,” known more formally as TAR-200, and eight who got cetrelimab, Janssen’s experimental PD-1 inhibitor. Of the eight patients who received cetrelimab, three had a complete response.
One patient who received cetrelimab had a serious case of myocarditis.
So far, patients in each arm were followed for a median time of around three months, with a data cutoff date of May 25, 2022.
The study was designed to look at how each of the treatments work on their own as well as in combination, though data on the combo arm were not presented at the meeting. Janssen declined to disclose when the combo data would be presented.
Chris Cutie
“Let’s establish a pretzel foothold,” Janssen’s bladder cancer lead Chris Cutie told Endpoints News, referring to the TAR-200 treatment arm. He noted that by itself, gemcitabine, the chemotherapy used in the pretzel, leads to around a 40% complete response rate at three months.
The pretzel was developed by Taris Biomedical, which J&J bought at the end of 2019 and where Cutie was previously chief medical officer. The pretzel is a long silicone tube that delivers the chemotherapy in very low doses over an extended period of time.
Janssen is also running a separate Phase III study in patients with muscle-invasive bladder cancer, which runs a higher risk of spreading to other parts of the body. For those patients, Cutie noted that the combo treatment was necessary because of that high risk of the cancer metastasizing.
For patients with NMIBC, however, who have a lower risk, Janssen is still determining which treatment route — the pretzel alone or in combination with an immune checkpoint inhibitor — will be best, he said.
“This is a piece of plastic with a 40-year old drug in it,” Cutie said. “It’s not CAR-T. It’s not gene therapy. It’s not an oncolytic virus, but it actually looks like it might work.”
“I hope it inspires other small little companies in this space to keep trying,” he added. “You may not have the shiny brass ring, but if you have something that has a shot on goal — keep moving.”
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