Matching-Adjusted Indirect Comparisons (MAIC) of TAR-200 vs FDA Approved Novel Agents in Bacillus Calmette-Guerin (BCG) Unresponsive High-Risk (HR) Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in Situ (CIS)

OBJECTIVES: FDA has approved pembrolizumab (pembro), nadofaragene firadenovec-vncg (nadofaragene), and nogapendekin alfa inbakicept-pmln (NAI) + BCG for the treatment of patients with BCG-unresponsive HR NMIBC with CIS. SunRISe-1 is investigating TAR-200, a novel targeted releasing system, and has shown a centrally assessed any time complete response (CR) rate of 84% in this population. In the absence of head-to-head data, MAICs were conducted to compare CR of TAR-200 vs FDA approved novel agents.
METHODS: Using individual patient data for TAR-200 from SunRISe-1 and comparator data from US prescribing information, unanchored MAICs were conducted to analyze CR rates at any time and at first disease assessment. The MAICs adjusted for imbalance of prognostic factors and treatment effect modifiers at baseline (from highest to lowest priority: tumor stage, prior doses of BCG instillation, ECOG, and age). Gender and race were also included for adjustment.
RESULTS: After weighting, baseline characteristics were similar across trials. TAR-200 had a higher adjusted CR rate at any time compared to all comparators and at first disease assessment compared to NAI + BCG. The adjusted absolute differences (95% CI) in CR at any time for TAR-200 vs pembro, nadofaragene, and NAI + BCG were 0.43 (0.29, 0.56), 0.38 (0.26, 0.50), and 0.26 (0.13, 0.39), respectively; and 0.52 (0.39, 0.66) for TAR-200 vs NAI + BCG at first disease assessment, based on calculated data that excluded patients who received a 2nd induction; p<0.05 for all comparisons.
CONCLUSIONS: TAR-200 demonstrated statistically significant clinical benefit in CR rate at any time over FDA approved novel agents in BCG-unresponsive HR NMIBC with CIS and at first disease assessment compared to NAI + BCG. Further analyses will be conducted once additional follow-up is available for TAR-200. Funding: J&J Innovative Medicine sponsored this study.