IMFINZI® (durvalumab) significantly improves event-free and overall survival in muscle-invasive bladder cancer: NIAGARA Phase III trial

AstraZeneca recently announced promising results from the NIAGARA Phase III trial involving their drug IMFINZI® (durvalumab) in combination with chemotherapy for treating muscle-invasive bladder cancer (MIBC). The study demonstrated significant improvements in both event-free survival (EFS) and overall survival (OS) when compared to the current standard of neoadjuvant chemotherapy alone for patients with MIBC. Participants received IMFINZI alongside chemotherapy prior to bladder removal surgery (cystectomy) and continued with IMFINZI as a solo treatment afterward.

MIBC is a severe form of bladder cancer where the tumor penetrates the muscle wall of the bladder. This condition affects approximately 25% of bladder cancer patients, which translates to around 117,000 individuals annually receiving the current standard treatment that includes neoadjuvant chemotherapy and radical cystectomy. Despite undergoing bladder removal surgery, a significant number of patients face high recurrence rates and poor prognosis.

Professor Thomas Powles from Barts Cancer Centre in London, who is also an investigator in the trial, highlighted the critical need for more effective treatments. He emphasized that nearly half of patients with MIBC who receive standard care still suffer from disease recurrence or progression. The NIAGARA trial results indicate that adding durvalumab to the treatment regimen before and after surgery could prolong the lives of these patients.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, noted that the NIAGARA findings align with the company’s strategy to incorporate immunotherapy earlier in cancer treatment. By improving survival rates and reducing disease recurrence, this perioperative regimen featuring IMFINZI could revolutionize standard care for bladder cancer patients.

IMFINZI was well tolerated by patients, and no new safety issues were observed in either the neoadjuvant or adjuvant settings. The frequency of adverse events and discontinuation rates due to these events were comparable to those observed with neoadjuvant chemotherapy alone. AstraZeneca plans to present these findings at an upcoming medical conference and share the data with global regulatory bodies.

Bladder cancer, identified as the ninth most common cancer globally, results in over 614,000 new cases each year. Urothelial carcinoma, which originates in the urothelial cells lining the urinary tract, is the most prevalent form. MIBC, characterized by the tumor's invasion into the muscle layer of the bladder, accounts for about 25% of all bladder cancer cases. Unfortunately, about half of the patients undergoing cystectomy experience disease recurrence, creating an urgent need for treatments that can prevent this.

The NIAGARA trial is a large-scale, open-label, multi-center global Phase III study evaluating the efficacy of IMFINZI as a treatment for MIBC, both before and after cystectomy. The trial enrolled 1063 patients who were randomized to receive either IMFINZI with chemotherapy or chemotherapy alone before surgery, followed by IMFINZI or no further treatment post-surgery. Conducted at 192 centers across 22 countries, the trial’s primary endpoints include EFS and pathologic complete response, with key secondary endpoints being OS and safety.

IMFINZI (durvalumab) is a monoclonal antibody that targets the PD-L1 protein, inhibiting its interaction with PD-1 and CD80 proteins, thereby countering the tumor's ability to evade the immune system. This mechanism enables the immune system to attack the cancer cells more effectively. IMFINZI has already established itself as a global standard for treating unresectable Stage III non-small cell lung cancer (NSCLC) and is approved for other cancers including extensive-stage small cell lung cancer (SCLC) and biliary tract cancer (BTC).

AstraZeneca is committed to advancing cancer care through innovative immunotherapies. Their approach aims to deliver long-term survival benefits by introducing immunotherapy at early stages of cancer treatment and exploring novel combination treatments to overcome resistance and prolong immune responses. With a robust clinical program, AstraZeneca continues to push the boundaries in oncology, striving to transform patient outcomes and ultimately eliminate cancer as a cause of death.