María Natalia Gandur Quiroga: Imfinzi Shows Significant Survival Benefits in NIAGARA Phase III Trial
María Natalia Gandur Quiroga shared on LinkedIn: .
“Imfinzi Shows Significant Survival Benefits in NIAGARA Phase III Trial
Published: 25 June 2024
First Immunotherapy Regimen Before and After Surgery to Extend Survival in Bladder Cancer
Positive high-level results from the NIAGARA Phase III trial demonstrated:
- ️Improvement in Event-Free Survival (EFS): Statistically significant and clinically meaningful.
- ️Improvement in Overall Survival (OS): Key secondary endpoint significantly improved.
- ️Treatment Regimen: Imfinzi (durvalumab) combined with neoadjuvant chemotherapy before cystectomy and as adjuvant monotherapy after surgery.
- ️Patient Population: Muscle-invasive bladder cancer (MIBC) patients.
- Safety Profile: Consistent with known profiles of the individual medicines, no new safety concerns.
Context and Comments:
- High Recurrence Rates: Nearly 50% of MIBC patients experience disease recurrence post-surgery.
- Expert Insight: Prof. Thomas Powles highlighted the survival benefits of adding durvalumab to the standard chemotherapy regimen.
- AstraZeneca’s Strategy: Moving immunotherapy to earlier stages of cancer treatment to improve outcomes.
NIAGARA Trial Details
- Design: Randomised, open-label, multi-centre, global Phase III trial.
- Participants: 1063 patients with MIBC.
- Endpoints: EFS and OS as primary endpoints; safety as a key secondary endpoint.
- ️Geographical Scope: 192 centres across 22 countries.
Imfinzi Overview
- Mechanism: Binds to PD-L1 protein, blocking interactions that allow tumours to evade the immune system.
- Approvals: For use in various cancers including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer, and hepatocellular carcinoma (HCC).
Clinical Development: Ongoing trials across a range of cancer types, including early- and late-stage bladder cancer.
AstraZeneca in Immuno-Oncology
Innovative Approaches: Developing therapies that stimulate the immune system to target cancer.”
Read further.
Source: María Natalia Gandur Quiroga/LinkedIn
Maria Natalia Gandur Quiroga is a Medical Oncologist and Chief of the Division of Genitourinary Medical Oncology at the Instituto de Oncología Ángel H. Roffo in Buenos Aires, Argentina. She is a Professor of Medicine at the University of Buenos Aires at the Oncologists Post Graduates Studies. Her research focuses on clinical trials with aims to improve the treatment of patients with urologic tumors. She is an active member of the European Association for Cancer Research, Argentinian Medical Association and American Society of Clinical Oncology.