SUMMARY

• A matching adjusted indirect comparison (MAIC) evaluated individual patient data (IPD) from the BLC2001 study for BALVERSA compared to aggregated data from published randomized controlled trials (RCTs) for existing second-line treatments, including paclitaxel.^1,2
  • The hazard ratio (HR) for overall survival (OS) favored BALVERSA compared to paclitaxel (HR: 0.592; 95% confidence interval [CI]: 0.370-0.948; P=0.0292) in patients with metastatic urothelial carcinoma (mUC). Safety data were not reported.²

Clinical Data

Indirect Comparison Study

Loriot et al (2019)² conducted a MAIC study to compare the efficacy of BALVERSA with existing second-line treatments, including paclitaxel, for the treatment of mUC. The study evaluated overall response rate (ORR; total number of patients with complete or partial response), OS and progression-free survival (PFS) utilizing IPD from the BLC2001 study for BALVERSA and aggregated data from published RCTs for comparators.

• The matching adjusted odds ratios (OR) for ORR was statistically significant for BALVERSA compared to paclitaxel (OR: 2.634; 95% CI: 1.031-6.728; P=0.0430).
• The matching adjusted HR for OS showed significant improvement with BALVERSA compared to paclitaxel (HR: 0.592; 95% CI: 0.370-0.948; P=0.0292).
• In addition, the matching adjusted HR for PFS was in favor of BALVERSA compared to paclitaxel (HR: 0.947; 95% CI: 0.639-1.405; P=0.7874).
• Safety data were not reported.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DERWENT Drug Files (and/or other resources, including internal/external databases) was conducted on 30 May 2024.