Protara to Unveil 12-Month Interim Data from 31-Patient Phase 2 Bladder Cancer Trial
Protara will present updated safety and efficacy data from 31 BCG-naïve non-muscle invasive bladder cancer patients in its Phase 2 ADVANCED-2 trial at the AUA Annual Meeting May 15–18 in Washington, DC. A separate poster will detail interim results for the BCG-unresponsive cohort following six weekly instillations and three-week maintenance of TARA-002.
1. ADVANCED-2 Phase 2 Trial Overview
ADVANCED-2 (NCT05951179) is an open-label Phase 2 trial assessing intravesical TARA-002 in high-grade non-muscle invasive bladder cancer patients, including both BCG-naïve and BCG-unresponsive cohorts, with subjects receiving six weekly instillations followed by maintenance dosing every three months.
2. BCG-Naïve Cohort Interim Data Presentation
Interim safety and efficacy data from Cohort A as of April 5 were derived from 31 BCG-naïve patients; these results will be presented by Dr. Mark Tyson on May 15 from 7:00 to 9:00 a.m. in the Non-invasive I session at the AUA Annual Meeting.
3. BCG-Unresponsive Cohort Encore Presentation
A second poster will reprise interim findings from Cohort B, encompassing BCG-unresponsive patients treated under the same regimen; Dr. Timothy Clinton will present these metrics on May 15 from 3:30 to 5:30 p.m. in the Non-invasive II session.
4. TARA-002 Therapy Profile
TARA-002 is a first-in-class TLR2/NOD2 agonist granted Breakthrough, Fast Track, and Rare Pediatric Disease designations, designed to activate innate and adaptive immune pathways, induce cytokine release, and trigger immunogenic cell death in bladder tumors.