AstraZeneca announces results from POTOMAC trial

Results from the POTOMAC Phase III trial showed one year of treatment with AstraZeneca’s (AZN) Imfinzi plus standard-of-care BCG induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk non-muscle-invasive bladder cancer compared to BCG induction and maintenance therapy alone. The trial was not statistically powered to formally test overall survival however a descriptive analysis demonstrated no detriment. The safety and tolerability of Imfinzi plus BCG induction and maintenance therapy was consistent with the known safety profiles of the individual medicines, with no new safety concerns identified. The addition of Imfinzi did not compromise patients’ ability to complete BCG induction and maintenance therapy. The second experimental arm evaluating Imfinzi plus BCG induction-only therapy compared to BCG induction and maintenance therapy alone did not meet the endpoint of DFS. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.