Protara Therapeutics’ solid tumour-focused cell therapy, TARA-002, has demonstrated its potential to elicit a durable response in patients with non-muscle invasive bladder cancer (NMIBC) during a Phase II trial.
The open-label ADVANCED-2 study (NCT05951179) enrolled 31 patients with NMIBC who were either naïve or unresponsive to treatment with the Bacillus Calmette-Guérin (BCG) vaccine, which is standard of care (SoC). Patients were given six weekly doses of TARA-002 as an induction, with or without a reinduction, followed by a maintenance regimen of three weekly doses every three months.
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During the trial, TARA-002 elicited complete responses (CR) in 55% of the 29 BCG-naïve, efficacy-evaluable patients at the 12-month mark, while the CR rate at any time during the study stood at 72%.
Among responders to the intravesically-administered therapy, a Kaplan-Meier estimate revealed that patients had a 73.1% chance of maintaining a CR for six months, while 11 out of 12 (91.7%) who exhibited a CR to treatment at nine months maintained this impact up until the 12-month milestone.
Alongside TARA-002’s promising efficacy, the cell therapy was also proven safe and tolerable for use. Most patients treated with the drug experienced mild treatment-emergent adverse events (TEAEs) classified as Grade 1, and no patients experienced TEAEs of Grade 3 or higher.
In a statement, Protara’s CEO, Jesse Shefferman, expressed his excitement around the results, noting that the data demonstrates TARA-002’s competitive efficacy with approved and investigational therapies currently in development.
Protara presented these results during a poster session at the 2026 American Urological Association (AUA) annual meeting, which is currently ongoing in Washington D.C.
Addressing unmet needs in NMIBC
Following the positive outcome of the ADVANCED-2 study, Protara plans to begin a registrational study on TARA-002 in BCG-naïve patients and potentially BCG-exposed patients during the second half of 2026, in which operators will pit the cell therapy against intravesical chemotherapy – a widely used therapeutic option for NMIBC.
In a statement, ADVANCED-2 study investigator and Mayo Clinic professor of urology, Mark Tyson, noted that the 12-month data from this trial and TARA-002’s “streamlined administration” could make the drug a “potentially important new treatment option for BCG-naïve, high-risk NMIBC patients.”
Currently, the SoC for NMIBC revolves around surgical resection, intravesical chemotherapy and treatment with the BCG vaccine, meaning there is a strong need for effective, bladder-sparing treatment options.
If approved, TARA-002 would become the first cell therapy to secure the regulatory greenlight for use in patients with NMIBC, and the first to achieve this milestone in the BCG-naïve population.
Recently, in the NMIBC space, enGene’s detalimogene voraplasmid touted a 63% CR rate in BCG-unresponsive patients during the pivotal LEGEND study (NCT04752722), while Johnson & Johnson’s intravesical drug-releasing system, Erda-iDRS (erdafitinib), posted a median CR duration of 18 months in intermediate-risk patients receiving non-surgical treatment.
