Data readout puts J&J's bladder cancer drug back on track

 Johnson & Johnson's confidence in its bladder cancer therapy TAR-200 – dented by a negative phase 3 readout last year – seems to be justified.

New data from the SunRISe-1 study of TAR-200 in patients with high-risk, non-muscle-invasive bladder cancer (HR-NMIBC) that has not responded to standard BCG treatment build the case for the drug as it heads towards an FDA decision on a marketing application in NMIBC later this year.

At the American Urological Association (AUA) that starts later this week, J&J is scheduled to report that TAR-200 achieved a 12-month duration of response in this form of bladder cancer, allowing patients with the highly recurrent disease to remain cancer-free for a longer period.

Moreover, it will also present what it says is "compelling" data from a new SunRISe-1 cohort involving patients with BCG-unresponsive, papillary-only HR-NMIBC, a group who are typically elderly and with significant co-morbidities.

Surgical removal of the bladder is the standard treatment option for this form of the disease, which can be challenging in this group, so an alternative that can delay the need for such an invasive procedure would be a major step forward for patients.

TAR-200 takes the form of a silicon-based drug delivery device that allows for the continuous release of medication – in this case the chemotherapy agent gemcitabine – directly into the bladder. It is inserted by a healthcare professional in a brief outpatient procedure, without the need for anaesthesia.

Last October, J&J reported disappointing results from the SunRISe-2 study of TAR-200, which involved people with muscle-invasive bladder cancer (MIBC) who were not receiving surgery to remove the bladder (cystectomy) and nearby lymph nodes. In that trial, the drug showed no improvement over the standard chemoradiation treatment.

At the time, the company said the readout was disappointing, but had no bearing on its projections of a $5 billion-plus peak sales potential for TAR-200 and other drugs based on the delivery technology, acquired when it bought Taris in 2019.

At AUA, there will also be a presentation on the phase 3 MoonRISe-1 trial of TAR-210, an intravesical formulation of J&J's FGFR kinase inhibitor Balversa (erdafitinib), which is being run in intermediate-risk NMIBC.

"Patients deserve more than the currently available treatment options," said Biljana Naumovic, US president, oncology, solid tumours, at J&J. "This innovation provides a bladder-sparing treatment option that can meaningfully improve outcomes while integrating seamlessly into any urology practice."

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