Félix Guerrero-Ramos, MD, highlights key takeaways from POTOMAC trial

In an interview at the 2025 European Society for Medical Oncology (ESMO) Congress, in Berlin, Germany, Félix Guerrero-Ramos, MD, PhD, FEBU, shared key findings from the phase 3 POTOMAC trial (NCT03528694), which evaluated the combination of durvalumab (Imfinzi) plus BCG for patients with BCG-naïve high-risk non–muscle invasive bladder cancer (NMIBC).

In total, the study enrolled 1018 patients who were randomly assigned to receive durvalumab plus BCG induction and maintenance (n = 339), durvalumab plus BCH induction only (n = 339), or BCG alone (n = 340). Overall, data showed that the combination of durvalumab plus BCG induction and maintenance led to a significant improvement in disease-free survival compared with BCG alone (HR, 0.68; P = .0154).¹

“This opens the opportunity for a new therapy for patients with high risk non–muscle invasive bladder cancer,” Guerrero-Ramos noted. Guerrero-Ramos is the coordinator of the uro-oncology unit at the Hospital Universitario 12 de Octubre, Madrid, Spain.

During the discussion, Guerrero-Ramos also highlighted key findings from other trials in this setting.

At the 2025 American Urological Association Annual Meeting, data from the phase 3 CREST trial (NCT04165317) showed that the combination of sasanlimab plus BCG (induction and maintenance) significantly improved event-free survival (EFS) vs BCG alone (HR, 0.68; 95% CI, 0.49 to 0.94; 2-sided P = .019).² Further, data from the phase 3 ALBAN trial (NCT03799835) were also presented at ESMO, showing that the combination of atezolizumab (Tecentriq) plus BCG did not extend event-free survival (EFS) compared with BCG alone.³

“There are [likely] slight differences in the design of the trials and in the populations included that may have not led ALBAN to be positive,” Guerrero-Ramos explained.

He also noted that we are still awaiting results from the KEYNOTE-676 trial (NCT03711032), evaluating pembrolizumab (Keytruda) plus BCG for patients with persistent/recurrent HR NMIBC after first BCG induction.

REFERENCES

1. De Santis M, Palou J, Nishiyama H, et al. Durvalumab (D) in combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. Presented at: European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract LBA108. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA108.html.pdf

2. Shore ND, Powles T, Bedke J, et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette Guérin as standard of care in high-risk non-muscle invasive bladder cancer: Phase 3 CREST study results. J Urol. 2025;213(5S).

3. Roupret M, Bertaut A, Pignot G, et al. ALBAN: A phase III, randomized, open-label international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA110. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA107.html.pdf