Positive high-level results from the NIAGARA Phase III trial showed AstraZeneca's IMFINZI (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC).
Patients were treated with IMFINZI in combination with neoadjuvant chemotherapy before cystectomy (surgery to remove the bladder) followed by IMFINZI as adjuvant monotherapy.
Approximately one in four patients with bladder cancer has evidence of the tumor invading the muscle wall of the bladder (without distant metastases), known as MIBC.1,2 In the MIBC setting, approximately 117,000 patients are treated with current standard of care.3 Standard treatment includes neoadjuvant chemotherapy and radical cystectomy.4 However, even after cystectomy, patients experience high rates of recurrence and a poor prognosis.4
Professor Thomas Powles, MD, Professor, Director of Barts Cancer Centre (QMUL), London, UK, and investigator in the trial, said: 'Nearly half of patients with muscle-invasive bladder cancer who receive standard of care still experience disease recurrence or progression. These NIAGARA data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients' lives.'
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: 'The NIAGARA results support our strategy to move immunotherapy to the early stages of cancer treatment. This perioperative regimen with IMFINZI improved survival and reduced the rate at which patients experience disease recurrence or progression. We are eager to bring this regimen with the potential to transform the standard of care to patients as soon as possible.'
IMFINZI was generally well-tolerated and no new safety concerns were observed in either the neoadjuvant or adjuvant setting. The safety profile of IMFINZI and neoadjuvant chemotherapy was consistent with the known profile of the individual medicines. The addition of IMFINZI did not increase the discontinuation rate due to adverse events and did not compromise patients' ability to complete surgery compared to neoadjuvant chemotherapy alone. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
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-tumor immune response and stimulate the body's immune system to attack tumors.
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 as well as 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 program, 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 catalyze 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 is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide.
Contact:
Brendan McEvoy
Tel: +1 302 885 2677
Chelsea Tressler
Tel: +1 302 855 2677
Email: usmediateam@astrazeneca.com
ASTRAZENECA PLC 
