- Phase 2b SunRISe-4 study shows INLEXZO™ plus cetrelimab achieves 38% pathologic complete response rate.
- INLEXZO™ plus cetrelimab shows 53% pathologic overall response rate and 77% one-year recurrence-free survival.
- 81.2% of patients on INLEXZO™ plus cetrelimab experienced treatment-related adverse events, 15.8% at Grade ≥3.
- Exploratory results suggest urine and circulatory tumor DNA as potential predictive biomarkers.
Study Overview
The Phase 2b SunRISe-4 study evaluated the efficacy of INLEXZO™ (gemcitabine intravesical system) combined with intravenous cetrelimab in patients with muscle invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy. The study involved two cohorts: one receiving INLEXZO™ plus cetrelimab and the other receiving cetrelimab monotherapy.
Key Findings
The combination therapy achieved a pathologic complete response (pCR) rate of 38% and a pathologic overall response (pOR) rate of 53%. The one-year recurrence-free survival (RFS) was 77% for the combination therapy. In comparison, cetrelimab monotherapy showed a pCR rate of 28%, a pOR rate of 44%, and a one-year RFS of 64%.
Safety Profile
No new safety signals were observed with the combination therapy. In the cohort receiving INLEXZO™ plus cetrelimab, 81.2% experienced treatment-related adverse events (TRAEs), with 15.8% at Grade ≥3. Common adverse events included dysuria, pollakiuria, and fatigue. Serious TRAEs occurred in 13.9% of patients, but no treatment-related deaths were reported.
Biomarker Exploration
Exploratory results from the study suggest that urine tumor DNA and circulatory tumor DNA could serve as predictive biomarkers for residual disease after neoadjuvant therapy in this patient population.
