A new treatment for bladder cancer has shown promising results in a phase 2 trial. TAR-200, an intravesical drug-releasing system, provided durable disease-free survival outcomes in patients with high-risk, BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) who had papillary-only disease.
According to the study’s lead author, Felix Guerrero-Ramos, MD, PhD, patients treated with TAR-200 experienced a 95.6% progression-free survival and 98% overall survival at nine months. The treatment was also shown to reduce the need for radical cystectomy, with only 5.8% of patients undergoing surgery.
The study involved 52 patients who received TAR-200 monotherapy, and the results were consistent across both high-grade Ta and T1 disease stages. Patients had previously been unresponsive to BCG therapy or had declined surgery.
While safety concerns were noted, with 80.8% of patients experiencing any-grade treatment-related adverse effects, the overall response was positive. The FDA has recently received a new drug application seeking approval for TAR-200 in this setting, based on prior data from SunRISe-1.
TAR-200 is designed to provide sustained delivery of gemcitabine through all layers of the bladder wall, and its ongoing phase 3 trial, SunRISe-5, aims to further evaluate its potential. The study’s results suggest that TAR-200 may be a promising treatment option for patients with BCG-unresponsive high-risk NMIBC who have papillary-only disease.
Source: https://www.onclive.com/view/tar-200-yields-prolonged-dfs-in-bcg-unresponsive-papillary-high-risk-nmibc