Imfinzi Regimen Cuts Recurrence Risk by a Third and Boosts Two-Year Survival in Bladder Cancer

(IN BRIEF) The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) combined with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi adjuvant monotherapy, for adults with resectable muscle-invasive bladder cancer. This approval is anchored in NIAGARA Phase III trial data showing a 32% reduction in the composite risk of disease progression, recurrence, failure to undergo surgery, or death (EFS HR 0.68; p<0.0001) and a 25% decrease in mortality risk (OS HR 0.75; p=0.0106) compared to chemotherapy alone. Two-year event-free and overall survival rates favored the Imfinzi regimen (67.8% vs. 59.8% and 82.2% vs. 75.2%, respectively). The treatment was well tolerated, with manageable immune-mediated adverse events and no impact on surgical completion. ESMO awarded the regimen its highest “A” grade on the Magnitude of Clinical Benefit Scale in the curative setting. Imfinzi’s approval in this setting follows its established role in lung cancer and ongoing global regulatory submissions.

(PRESS RELEASE) CAMBRIDGE, 4-Jul-2025 — /EuropaWire/ — AstraZeneca today announced that the European Commission has granted approval for its immunotherapy Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as a neoadjuvant regimen, followed by adjuvant Imfinzi monotherapy, for adult patients with resectable muscle-invasive bladder cancer (MIBC). This decision follows a favorable recommendation from the Committee for Medicinal Products for Human Use and is supported by robust data from the global NIAGARA Phase III trial, recently published in The New England Journal of Medicine.

In a planned interim analysis of NIAGARA, the perioperative Imfinzi-containing regimen achieved a 32% reduction in the composite risk of disease progression, recurrence, failure to undergo surgery, or death compared to neoadjuvant chemotherapy alone plus radical cystectomy (event-free survival hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.56–0.82; p<0.0001). Median event-free survival remained immature for the Imfinzi arm, while the chemotherapy-only arm recorded a median EFS of 46.1 months. At two years, an estimated 67.8% of patients in the Imfinzi group were event free versus 59.8% in the comparator cohort.

Key secondary analyses demonstrated a 25% reduction in the risk of death with the Imfinzi-based approach (overall survival HR 0.75; 95% CI 0.59–0.93; p=0.0106), with median overall survival not yet reached in either arm. Two-year survival estimates were 82.2% for the Imfinzi regimen compared to 75.2% for chemotherapy alone.

MIBC affects over 35,000 patients annually across the five largest European markets, yet even in this curative-intent setting approximately half of operated patients experience recurrence. Adding Imfinzi to standard neoadjuvant chemotherapy therefore addresses a critical unmet need by substantially lowering relapse and mortality risks.

Dr. Michiel Van der Heijden, medical oncologist and NIAGARA investigator at the Netherlands Cancer Institute, commented: “NIAGARA’s results underscore the transformative potential of integrating durvalumab into perioperative care for bladder cancer. By reducing recurrence risk by nearly one-third and significantly improving survival, this regimen sets a new benchmark in a field where progress has been limited.”

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, added: “As the first and only immunotherapy approved perioperatively for MIBC in Europe, Imfinzi offers patients and clinicians an innovative path to better outcomes. Seeing over 80% of patients alive at two years highlights the regimen’s impact in this high-risk population.”

The safety profile of Imfinzi in the neoadjuvant and adjuvant settings was consistent with prior studies, with no new adverse events identified. Immune-mediated side effects aligned with expectations and were generally manageable, and the addition of Imfinzi did not impede completion of planned surgeries.

Supporting this approval, the European Society for Medical Oncology (ESMO) assigned the NIAGARA regimen an “A” grade on its Magnitude of Clinical Benefit Scale for curative treatments. Imfinzi is already approved in the U.S. and other regions for this indication, with applications underway in Japan and additional countries. Beyond bladder cancer, Imfinzi has received approvals in multiple curative-intent lung cancer settings and is under investigation across various malignancies, reflecting a broad and evolving development program.

Notes

Muscle-invasive bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year.5 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.6 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.6 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.2 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting.

NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting.

The trial is being conducted at 192 centres in 22 countries across North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response at the time of cystectomy. Key secondary endpoints are OS and safety.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In May 2025, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

In lung cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of EFS in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours.

AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

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