Video
Nick James: BladderPath trial at ESMO 2025
Nick James (The Institute of Cancer Research, London, UK) discusses the BladderPath trial, presented at ESMO Congress 2025
What is it about?
Highlights from the European Society for Medical Oncology Congress (ESMO) 2025:
The 2025 ESMO Congress presented new findings from three key trials that could influence future management strategies for non–muscle-invasive bladder cancer (NMIBC), known for its high recurrence and progression risk. Current standard care involves transurethral resection of bladder tumor (TURBT) and intravesical Bacillus Calmette–Guérin (BCG), but there are challenges in optimizing staging and improving long-term outcomes.
The BladderPath trial explored whether an MRI-directed diagnostic approach could replace routine TURBT staging, using MRI to differentiate between muscle-invasive and non–muscle-invasive pathways to expedite treatment for muscle-invasive disease without compromising outcomes for early-stage patients.
Two phase 3 trials examined the addition of systemic immunotherapy to standard intravesical treatment for high-risk patients with no prior BCG exposure.
ALBAN evaluated atezolizumab plus BCG versus BCG alone in 516 patients with high-grade Ta/T1 tumors and/or carcinoma in situ following TURBT, aiming to determine whether combination therapy could improve event-free survival.
POTOMAC investigated durvalumab with BCG in 1,018 patients randomized into three groups: durvalumab + BCG induction and maintenance, durvalumab + BCG induction only, or BCG alone, aiming for more durable disease-free responses than BCG alone.
Why is it important?
Bladder cancer management faces challenges in timely diagnosis and reducing recurrence risk in NMIBC. Trials provide evidence that may impact staging and treatment selection.
BladderPath showed MRI triage halves time to treatment, reducing pathways from approximately 100 to 45 days. TURBT staging often delays treatment for muscle-invasive disease by up to 100 days, increasing risk of progression. Early data suggest improved bladder cancer–specific survival with MRI guidance, positioning MRI as a practical, scalable alternative to traditional staging.
ALBAN data reported adding atezolizumab to BCG did not improve event-free survival and increased toxicity, underscoring the need for careful safety considerations, patient selection, and biomarker-driven strategies when integrating immunotherapy into NMIBC care.
POTOMAC trial demonstrated a statistically significant improvement in disease-free survival with durvalumab + BCG induction and maintenance versus BCG induction and maintenance alone, sustained over a median follow-up of 60.7 months. This durable response suggests that combining immunotherapy with BCG may offer a potential new standard option for BCG-naive, high-risk patients.
Key takeaways:
- MRI-based triage may accelerate diagnosis and treatment planning
- Immunotherapy combinations show variable benefit – patient selection is key
- Safety, biomarkers, and long-term follow-up remain essential to decision-making
- Evidence supports a shift toward personalized NMIBC management
