Imfinzi Regimen Demonstrates Positive, Meaningful Outcomes in Phase III Bladder Cancer Trial
In the POTOMAC study, one year of treatment with Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy showed a meaningful improvement in disease-free survival.
AstraZeneca has shared positive results from its Phase III POTOMAC trial of Imfinzi (durvalumab) plus standard-of-care (SOC) Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The one-year treatment regimen demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS).1
In addition to the improvement in DFS, no new safety signals were identified. The safety and tolerability of the Imfinzi plus BCG induction and maintenance therapy regimen was consistent with the known safety profiles of the individual medicines. The second arm of POTOMAC, which evaluated Imfinzi plus BCG induction-only therapy compared to BCG induction and maintenance therapy alone, did not meet its DFS endpoint.
According to AstraZeneca, POTOMAC was not statistically powered to formally test overall survival (OS). However, a descriptive analysis demonstrated no detriment.
In a press release, Maria De Santis, MD, head of the interdisciplinary uro-oncology section at Charité Universitätsmedizin Berlin, Germany, and a principal investigator in the POTOMAC trial, said: “These exciting data show that adding one year of durvalumab to the current standard treatment significantly extends the time patients live without high-risk disease recurrence or progression. While most patients with non-muscle invasive bladder cancer are treated with curative intent, 80 percent see their disease return and almost half may require life-altering surgery to remove the bladder, underscoring the urgent need to improve treatment."
The Phase III POTOMAC trial is a randomized, open-label, multi-center, global study. It includes 1,018 patients with high-risk, BCG-naïve NMIBC who have undergone TURBT prior to randomization. These patients were randomized to receive Imfinzi plus BCG induction and maintenance therapy, or Imfinzi plus BCG induction-only therapy, versus SOC BCG induction and maintenance therapy.
In the press release, Cristian Massacesi, chief medical officer and oncology chief development officer, AstraZeneca, added: “The positive results for imfinzi in the POTOMAC trial represent a significant advance that will potentially allow more patients with early-stage bladder cancer to benefit from this important immunotherapy. Building on the NIAGARA data, this outcome demonstrates our strategy of bringing novel therapies to patients with early-stage disease where there is the greatest potential for long-term benefit.”
Earlier in March, AstraZeneca announced that Imfinzi had received approval in the EU as monotherapy for the treatment of adults with limited-stage small cell lung cancer disease has not progressed following platinum-based chemoradiation therapy. This marked the first and only approved immunotherapy for limited-stage small cell lung cancer in the EU.2
The approval was based on positive results from the Phase III ADRIATIC trial, in which Imfinzi demonstrated a 27% reduction in the risk of death versus placebo. Additional findings showed an estimated median OS of 55.9 months for Imfinzi versus 33.4 months for placebo.
In a press release from the time of the approval, Suresh Senan, PhD, radiation oncologist at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, said: “This approval marks a turning point for patients with limited-stage small cell lung cancer in Europe, bringing them an immunotherapy option for the first time. An unprecedented 57% of patients treated with durvalumab were still alive at three years in the ADRIATIC trial. This significant advance establishes a new benchmark in a setting where the standard of care has remained unchanged for decades.”
References
1. IMFINZI® (durvalumab) regimen demonstrated statistically significant and clinically meaningful improvement in disease-free survival for high-risk non-muscle-invasive bladder cancer in POTOMAC Phase III trial. News release. AstraZeneca. May 9, 2025. Accessed May 9, 2925. https://www.astrazeneca-us.com/media/press-releases/2025/IMFINZI-durvalumab-regimen-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-disease-free-survival-for-high-risk-non-muscle-invasive-bladder-cancer-in-POTOMAC-Phase-III-trial.html
2. Imfinzi approved in the EU as first and only immunotherapy for limited-stage small cell lung cancer. News release. AstraZeneca. March 17, 2025. Accessed May 9, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-eu-for-limited-stage-sclc.html
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