Dr Tyson on Efficacy Data From the ADVANCED-2 Trial in BCG-Naive High-Grade NMIBC

“What we observed at a high level was a complete response rate at any time of 72.4%; at 6 months the complete response rate was 66.7%, and at a year it was 55.0%. Six patients were re-induced, and 4 of them successfully converted to a complete response.”

Mark D. Tyson, II, MD, MPH, a urologic oncologist at Mayo Clinic, discussed data from cohort A of the ADVANCED-2 trial (TARA-002-101-Ph2; NCT05951179) evaluating TARA-002 for the treatment of patients with BCG-naive high-grade non–muscle-invasive bladder cancer.

ADVANCED-2 was designed to assess the efficacy of TARA-002 in a population that had not previously received BCG therapy and therefore represented an important group for evaluating the potential of this novel treatment approach.

A total of 31 patients were enrolled in the cohort, with 29 patients considered efficacy evaluable , Tyson said. At the time of the presentation, the median follow-up was approximately 9.44 months (range, 2.4-22.6), he added. The findings demonstrated encouraging antitumor activity, with high complete response (CR) rates observed across multiple time points, he said.

The primary efficacy results showed that 72.4% of evaluable patients achieved a complete response (CR) at any time during treatment, Tyson explained. Response durability remained favorable over time, with a CR rate of 66.7% (n = 18/27) at 6 months and 55.0% (n = 11/20) at 12 months, he noted. These results suggest that a substantial proportion of patients maintained disease control for extended periods following treatment with TAR-200.

Among responders, the Kaplan-Meier–estimated probability of maintaining a CR for 6 months was 73.1% (95% CI, 52.9%-93.4%). Most patients who achieved a CR maintained their CR from months 9 through 12 (91.7%). Moreover, most patients form whom TARA-200 was re-introduced (n = 6) converted to a CR at 6 months (66.7%). The majority of treatment-related adverse effects observed with the regimen were grade 1 and transient.

Overall, the ADVANCED-2 Cohort A data demonstrated promising efficacy for TARA-002 in BCG-naive CIS-containing NMIBC, Tyson concluded.