Bladder cancer patients with a common mutation saw promising early results after receiving a Johnson & Johnson targeted therapy that administers the drug sold as Balversa through a slow-releasing pretzel-shaped delivery device.
The treatment, known as TAR-210, delivers the bladder cancer drug slowly over time through a silicone tube called the “pretzel.” Balversa, also known as erdafitinib, is approved as an oral therapy, and hasn’t yet been cleared by the FDA for use in the device. But researchers hope delivering the medication with the device can spare patients from some of the drug’s side effects, including anemia, diarrhea, fatigue, mouth sores and hair loss. It’s similar to another experimental J&J bladder cancer treatment, TAR-200, which uses the “pretzel” to deliver chemotherapy.
In TAR-210’s Phase 1 study, which was presented Sunday at the American Urological Association’s annual meeting, the first cohort featured patients with high-risk non-muscle invasive bladder cancer (NMIBC) — meaning their cancer has not yet spread deeper into the muscle of the bladder, but is at risk of doing so. These patients received a standard vaccine treatment called Bacillus Calmette-Guérin to no avail, and then refused or were ineligible for bladder removal surgery. In the 21 patients who received J&J’s treatment through the device, 90% did not see their cancer recur at the one-year mark.
J&J also reported results from the third cohort of the study: those with recurrent, intermediate-risk non-muscle invasive bladder cancer. In the 31 patients in this group, 90% saw their tumors disappear.
“FGFR genetic alterations are most common in NMIBC,” Sabine Brookman-May, J&J’s VP of late development oncology, said in a statement. “These results further support the potential of TAR-210 with quarterly administration as a bladder-sparing and BCG-free treatment option.”
The results were updated from interim data shared at the European Association of Urology’s annual meeting in April.
In March, J&J began a Phase 3 study called MoonRISe-1, testing the drug delivered via the “pretzel” in patients with intermediate-risk non-muscle invasive bladder cancer.
In 2019, the FDA approved Balversa as the first FGFR kinase inhibitor for patients with select FGFR-mutated bladder cancers. The treatment later received full approval for a population of advanced bladder cancer patients with certain FGFR mutations.
The most common adverse events following treatment with TAR-210 were grade 1 or 2 lower urinary tract events. Two patients discontinued the study due to low-grade urinary symptoms, and two patients experienced serious adverse events — one had kidney infection and sepsis, and the other a urinary tract infection and sepsis.
On Friday, J&J also reported that 48 of 58 bladder cancer patients who received TAR-200, which uses the “pretzel” device to deliver chemotherapy, achieved a complete response.
Editor’s note: This story has been updated to clarify that Balversa is the approved name for the oral version of the drug.
