The trial was not statistically sufficient to formally test overall survival.（OS）, but descriptive analysis indicates no harm.

In terms of safety,The safety and tolerability of Imfinzi in combination with BCG induction and maintenance therapy are consistent with the known safety profiles of the individual drugs, with no new safety issues identified. The use of Imfinzi in combination does not affect the patient's ability to complete BCG induction and maintenance therapy.

More than 70% of bladder cancer patients are diagnosed with NMIBC, an early-stage cancer where the tumor is located in the tissue lining the inner surface of the bladder but has not yet invaded the bladder wall. Approximately half of NMIBC patients, due to certain characteristics of their cancer,(e.g., tumor grading, staging, and specific tumor characteristics)Classified as high-risk patients for disease progression or recurrence.

Although most patients with non-muscle-invasive bladder cancer receive curative treatment, 80% of them experience recurrence, and nearly half may require cystectomy.The positive results of Imfinzi in the POTOMAC trial represent a significant advancement, with the potential to benefit more patients with early-stage bladder cancer from this important immunotherapy.

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby interrupting tumor immune escape strategies and restoring suppressed immune responses. This drug has been approved for multiple indications in the United States, including:

• Unresectable, Stage III Non-Small Cell Lung Cancer Without Disease Progression After Concurrent Chemoradiotherapy Based on Platinum Drugs（NSCLC）；
• Combination of Etoposide and Carboplatin or Cisplatin as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）；
• In combination with gemcitabine and cisplatin, as first-line treatment for locally advanced or metastatic biliary tract cancer（BTC）；
• Combination with Tremelimumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma (HCC) Adult patients;
• In combination with tislelizumab and platinum-based chemotherapy, as first-line treatment for adult patients with metastatic NSCLC without sensitizing EGFR mutations or ALK gene mutations;
• In combination with carboplatin and paclitaxel, as first-line treatment for dMMR primary advanced or recurrent endometrial cancer;

• For neoadjuvant/adjuvant treatment of resectable NSCLC;

• Limited-stage small cell lung cancer with no disease progression after receiving platinum-based chemotherapy and radiotherapy (LS-SCLC) ；

• For the treatment of muscle-invasive bladder cancer (MIBC)。

Since its initial approval, sales of Imfinzi have been on the rise. 2024Global sales reached $4.717 billion, a year-on-year increase of 11.33%.。In the first quarter of 2025, Imfinzi achieved$12.21 billion, an increase of 16% year-on-year, ranking among the top three revenue-generating products in AstraZeneca's portfolio.

Screenshot source: Insight database