IMFINZI® regimen shows significant disease-free survival improvement in bladder cancer trial

Positive outcomes from the Phase III POTOMAC trial have revealed that adding one year of treatment with AstraZeneca’s IMFINZI (durvalumab) to standard Bacillus Calmette-Guérin (BCG) induction and maintenance therapy significantly extends disease-free survival (DFS) in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). This combination, compared to BCG alone, demonstrated a noteworthy reduction in the recurrence or progression of high-risk disease.

Bladder cancer is predominantly diagnosed as non-muscle-invasive in over 70% of cases, where the cancer remains in the bladder lining and has not penetrated the muscle wall. Approximately half of NMIBC cases are considered high-risk, characterized by factors like tumor grade and stage, indicating a higher likelihood of disease recurrence or progression. Dr. Maria De Santis, a principal investigator in the trial, highlighted the urgency of improving treatment for NMIBC, noting that while most patients are treated with curative intent, relapse is common, and many may ultimately face the need for significant surgical intervention.

The POTOMAC trial, conducted globally across more than 120 centers in 12 countries, assessed the effectiveness of IMFINZI plus BCG in over 1,000 high-risk NMIBC patients. These individuals had previously undergone a transurethral resection of the bladder tumor (TURBT) before being randomized into different treatment groups. The trial's primary focus was on DFS, defined as the duration from randomization to the first occurrence of high-risk disease recurrence or death from any cause. AstraZeneca’s Chief Medical Officer, Cristian Massacesi, emphasized the potential of these results to expand access to crucial immunotherapy for early-stage bladder cancer patients, reinforcing AstraZeneca’s strategy of introducing novel therapies for long-term patient benefits.

Importantly, the safety profile of IMFINZI combined with BCG therapy was consistent with known data, and no new safety concerns emerged. Patients tolerated the combination well, without any compromise on completing the standard BCG induction and maintenance therapy. However, the trial’s second arm, which evaluated IMFINZI with BCG induction only, did not achieve the DFS endpoint compared to the standard BCG therapy.

These groundbreaking results are set to be presented at an upcoming medical conference and shared with regulatory authorities worldwide. While IMFINZI is already approved in the U.S. and other countries for muscle-invasive bladder cancer (MIBC), these findings could further influence its application in NMIBC. The drug continues to be explored in various combinations and stages of bladder cancer, including for patients who cannot use or refuse cisplatin treatment.

IMFINZI, a monoclonal antibody targeting the PD-L1 protein, is a pivotal element of AstraZeneca’s immuno-oncology portfolio. It works by blocking the interaction of PD-L1 with PD-1 and CD80 proteins, thereby enhancing the immune system’s ability to combat cancer. Beyond bladder cancer, IMFINZI is approved for several other cancers, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), where it is often used in combination with chemotherapy or other treatments to exploit its immune-boosting potential.

AstraZeneca continues to drive advancements in oncology through its diverse portfolio and innovative approach to cancer treatment. By focusing on immunotherapy and exploring new combination therapies, the company aims to redefine cancer care and improve outcomes for patients globally. The results from the POTOMAC trial underscore AstraZeneca's commitment to pioneering treatments that offer significant clinical benefits and the promise of extended survival for cancer patients.