A recent study from the phase 3 POTOMAC trial has found that the combination of durvalumab (Imfinzi) and the standard Bacillus Calmette-Guérin (BCG) therapy significantly improves disease-free survival (DFS) for patients with high-risk non-muscle invasive bladder cancer (NMIBC). This finding highlights the potential of integrating immunotherapy with standard treatments for enhanced patient outcomes.
In the trial, patients receiving durvalumab in addition to BCG induction and maintenance therapy experienced a notable increase in DFS compared to those who only received BCG, although the study was not powered to formally assess overall survival (OS). A descriptive analysis did not indicate any negative impact on survival rates. Furthermore, the safety profile remained consistent with prior knowledge of both durvalumab and BCG, with no new safety signals reported. This signifies that adding durvalumab does not hinder patients from completing their full course of BCG therapy.
Maria De Santis, MD, who leads the uro-oncology section at Charité Universitätsmedizin Berlin and is a principal investigator in the trial, emphasized the urgency of improving treatment for NMIBC, as most patients—around 80%—experience disease recurrence, often leading to major surgeries like bladder removal. The data from the trial, particularly the significant extension of time patients live without the recurrence of high-risk disease, represents a pivotal advancement for this patient population.
The study involved a randomized assignment of 1,018 patients with high-risk early-stage bladder cancer across three groups: those receiving durvalumab alongside full BCG treatment, those receiving durvalumab with only the initial BCG phase, and those treated with BCG alone. Notably, the second experimental group that received combined therapy did not show an improvement over standard full BCG treatment.
Durvalumab is already FDA-approved for muscle-invasive bladder cancer treatment, supported by earlier studies like the phase 3 NIAGARA trial. The ongoing research for both early- and late-stage bladder cancer using durvalumab presents promising avenues for broader treatment options, particularly for patients who are ineligible for standard chemotherapy regimens.
These encouraging findings from the POTOMAC trial will be shared at forthcoming medical meetings and with global health authorities, potentially paving the way for enhanced therapeutic strategies in managing bladder cancer.
The advancements in treatment showcased by this trial offer hope to patients and healthcare providers alike, emphasizing the important role of innovation in cancer therapy.