WILMINGTON, DE — AstraZeneca has announced positive high-level results from its Phase III POTOMAC trial assessing the efficacy of IMFINZI® (durvalumab) combined with standard-of-care Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The groundbreaking study revealed that the addition of IMFINZI provided a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared to BCG alone, a pivotal finding for early-stage bladder cancer treatment.
Breakthrough for NMIBC Patients
NMIBC accounts for over 70% of bladder cancer diagnoses. It is characterized by tumors confined to the lining of the bladder without muscle wall invasion. Around 50% of these cases are classified as high-risk due to factors such as tumor grade and stage, predisposing patients to disease progression or recurrence. Current treatment primarily aims for curative outcomes; however, as many as 80% of NMIBC cases return, and approximately half may eventually require radical cystectomy, a surgery to remove the bladder.
The POTOMAC trial enrolled patients classified as high-risk and demonstrated that one year of durvalumab in combination with BCG induction and maintenance therapy significantly delayed the recurrence or progression of high-risk disease.
“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,” said Dr. Maria De Santis, Head of the Interdisciplinary Uro-Oncology Section at Charité Universitätsmedizin Berlin, Germany, and a principal investigator in the trial. “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.”
A descriptive analysis of overall survival (OS), which the trial was not statistically powered to formally evaluate, found no detriment for patients receiving IMFINZI versus those on BCG therapy alone.
Safety Profile and Additional Findings
The combination of IMFINZI with BCG induction and maintenance therapy was found to be safe and well-tolerated. The safety data were consistent with the known profiles of the individual treatments, and there were no new safety concerns identified. Importantly, the introduction of IMFINZI did not impede patients’ ability to complete the BCG induction and maintenance regimen.
The trial also included an experimental arm evaluating IMFINZI with BCG induction-only therapy, which did not achieve the endpoint of DFS improvement compared to the standard BCG regimen.
Expert Insights and Broader Implications
Commenting on these findings, Cristian Massacesi, AstraZeneca’s Chief Medical Officer and Oncology Chief Development Officer, said, “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.”
IMFINZI has already received approval in the U.S. and other countries for muscle-invasive bladder cancer (MIBC) based on data from the NIAGARA Phase III trial. It is also under investigation across multiple stages of bladder cancer, including through the VOLGA and NILE clinical programs.
Looking Ahead
The results of the POTOMAC trial represent a major development in the treatment of early-stage bladder cancer, addressing a significant unmet need in this high-risk patient population. By enhancing DFS without compromising safety, IMFINZI, in combination with BCG therapy, offers a promising new approach for NMIBC management. AstraZeneca plans to present the full findings at an upcoming medical conference and will engage with global regulatory authorities to bring this innovative therapy closer to clinical application.
The findings signal a shift in how high-risk bladder cancer patients may be managed, offering a treatment pathway that could reduce recurrence rates, extend disease-free intervals, and delay the need for invasive surgeries. With continued research, the insights from the POTOMAC trial will likely influence the next generation of immunotherapy strategies for NMIBC and beyond.
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