Astrazeneca’s IMFINZI cuts early recurrences in high-risk non-muscle-invasive bladder cancer

Fresh exploratory analyses from the Phase III POTOMAC trial suggest that adding one year of AstraZeneca’s IMFINZI® (durvalumab) to standard Bacillus Calmette-Guérin (BCG) induction and maintenance therapy roughly halves the number of high-risk disease events and BCG-unresponsive recurrences during the first year of treatment in patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC), when compared with BCG alone. The combination also delayed the need for bladder removal surgery and improved cystectomy-free survival.

The findings were presented today at the 2026 American Urological Association Annual Meeting (AUA) in Washington, DC.

Looked at by tumor subtype, the IMFINZI plus BCG regimen lowered the risk of high-risk disease recurrence, progression or death by 39% in patients with any papillary tumors (with or without carcinoma in situ [CIS]) and by 44% in those with papillary tumors only (no CIS), versus BCG alone — corresponding to disease-free survival (DFS) hazard ratios of 0.61 (95% CI 0.43–0.84) and 0.56 (95% CI 0.37–0.84; P=0.0046) respectively.

Neal Shore, MD, FACS, Director of START Carolinas / Head of the Carolina Urologic Research Center and co-principal investigator in the trial, said: “Nearly 40 percent of patients with high-risk non-muscle-invasive bladder cancer who relapse become unresponsive to BCG therapy and face a higher likelihood of bladder removal surgery. These new data from POTOMAC show that adding one year of durvalumab to BCG induction and maintenance therapy can reduce early high-risk recurrences and BCG-unresponsive recurrences, extending the time that patients live with their bladder intact and adding further compelling evidence for the benefit of this regimen for this group of patients.”

Leora Horn, Senior Vice President, Late Development Oncology, Oncology R&D, AstraZeneca, said: “These new analyses reinforce the benefit of IMFINZI plus BCG for patients with high-risk non-muscle-invasive bladder cancer, with data showing that this potential new treatment option reduces recurrences within the first year of treatment and decreases the risk of cystectomy. The results of POTOMAC build on the impact IMFINZI is having in muscle-invasive bladder cancer, further validating our approach to bring novel therapies into earlier-stage settings where they can have the greatest impact on patients’ lives.”

The latest analyses extend the headline POTOMAC results first reported at the 2025 ESMO Congress and simultaneously published in The Lancet, which showed the trial hit its primary endpoint of DFS. In the intent-to-treat population, the IMFINZI regimen reduced the risk of high-risk disease recurrence, progression or death by 32% versus the comparator arm (DFS HR 0.68; 95% CI 0.50–0.93; P=0.0154). Median DFS had not been reached in either arm; at two years, an estimated 87% of patients on the IMFINZI regimen remained alive and disease-free, compared with 82% on BCG alone.

Across the intent-to-treat population, 53 patients (16%) in the IMFINZI arm experienced a high-risk disease event versus 69 (20%) in the BCG-only arm, and of those events, 45% in the IMFINZI arm versus 61% in the comparator arm occurred within 12 months. BCG-unresponsive high-risk recurrences or persistent CIS accounted for 65% of events in the IMFINZI arm and 81% in the BCG-only arm. Median time from randomization to a high-risk disease event was 14.1 months with the IMFINZI regimen, versus 8.3 months with BCG alone.

On the cystectomy endpoints, 13 patients (4%) in the IMFINZI arm went on to bladder removal surgery compared with 21 (6%) in the BCG-only arm (HR 0.63; 95% CI 0.31–1.24); median time to cystectomy was not reached in either arm. Cystectomy-free survival favored the IMFINZI regimen, with 49 events (14%) versus 70 (21%) on BCG alone (HR 0.69; 95% CI 0.48–0.99). The safety and tolerability profile of IMFINZI plus BCG induction and maintenance was consistent with the known profiles of each agent, with no new signals after a median DFS follow-up of more than five years.

Regulatory submissions based on POTOMAC are currently under review in the US, EU, Japan and several other markets.

The update comes a day after AstraZeneca announced positive high-level findings from the Phase III VOLGA trial, in which perioperative IMFINZI plus neoadjuvant enfortumab vedotin (EV) produced statistically significant and clinically meaningful gains in event-free survival (EFS) and overall survival (OS) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or declined cisplatin-based chemotherapy. A separate VOLGA arm combining IMFINZI plus IMJUDO® (tremelimumab-actl) with neoadjuvant EV delivered a statistically significant and clinically meaningful EFS improvement and a favorable OS trend, though OS did not reach statistical significance at this planned interim analysis and will be reassessed later.

IMFINZI is currently approved in over 40 countries for patients with cisplatin-eligible MIBC on the strength of the Phase III NIAGARA trial, and continues to be evaluated in locally advanced or metastatic disease in the Phase III NILE study.

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Related Topics and Keywords

high-risk non-muscle-invasive bladder cancer, IMFINZI® (durvalumab)