Imfinzi wins nod as pre- and post-operative adjuvant therapy

for muscle-invasive bladder cancer

The first and only immunotherapy receiving indication approval in Korea

The Phase 3 NIAGARA clinical study results confirmed reduced mortality risk

Product photo of Imfinzi

AstraZeneca announced on August 4 that it has received approval for its Imfinzi (durvalumab) as pre- and post-operative adjuvant therapy for patients with muscle-invasive bladder cancer from the Ministry of Food and Drug Safety on July 30.

 

With this approval, Imfinzi has become the first and only immunotherapy in Korea to be approved for pre- and post-operative adjuvant therapy in the treatment of muscle-invasive bladder cancer.

 

Imfinzi's specific approved indication is for 'the treatment of patients with muscle-invasive bladder cancer as a neoadjuvant combination therapy with cisplatin and gemcitabine or as Imfinzi monotherapy as adjuvant therapy after radical cystectomy.' Imfinzi's specific approved indication is for 'the treatment of patients with muscle-invasive bladder cancer as a neoadjuvant combination therapy with cisplatin and gemcitabine or as Imfinzi monotherapy as adjuvant therapy after radical cystectomy.' The previous standard therapy was neoadjuvant chemotherapy followed by radical cystectomy.

 

However, this left an unmet need due to high recurrence rates and poor prognosis even after treatment.

 

It is known that approximately 50% of muscle-invasive bladder cancer patients experience recurrence within three years.

 

The expanded indication is based on the Phase 3 NIAGARA clinical study, which evaluated the clinical efficacy and safety of Imfinzi as a pre- and post-operative adjuvant therapy for muscle-invasive bladder cancer.

 

In this study, patients were divided into two groups.

 

The experimental group received Imfinzi and chemotherapy (gemcitabine-cisplatin) in combination as neoadjuvant therapy for 4 cycles at 3-week intervals, followed by surgery and then Imfinzi monotherapy as adjuvant therapy for 8 cycles at 4-week intervals.

 

The control group underwent chemotherapy (gemcitabine-cisplatin) as neoadjuvant therapy, followed by surgery only.

 

The study results showed that Imfinzi's pre- and post-operative adjuvant therapy significantly improved one of the key primary endpoints, event-free survival (EFS), compared to the control group.

 

The 2-year event-free survival rate was 67.8% for the Imfinzi pre- and post-operative adjuvant therapy group and 59.8% for the control group.

 

The Imfinzi pre- and post-operative adjuvant therapy reduced the risk of disease progression, recurrence, failure to undergo radical cystectomy (surgery), and death from all causes by 32%.

 

In terms of the safety profile, Imfinzi's results were consistent with the individual safety profiles of previously confirmed Imfinzi and chemotherapy (gemcitabine-cisplatin).

 

Based on these clinical benefits, Imfinzi is a Category 1 preferred recommendation for pre- and post-operative adjuvant therapy for patients with muscle-invasive bladder cancer in the National Comprehensive Cancer Network (NCCN) guidelines.

 

Furthermore, the European Society for Medical Oncology (ESMO) has rated it with an A-grade, the highest rating in their Magnitude of Clinical Benefit Scale (MCBS) framework.

 

Professor Byong Chang Jeong of the Department of Urology at Samsung Medical Center (President of the Korean Urological Oncology Society) explained, "The previous standard therapy for muscle-invasive bladder cancer had limitations in improving patient survival due to high recurrence rates," and added, "The newest approval of an immunotherapy as a pre- and post-operative adjuvant therapy is a favorable change in the clinical field." Jeong added, "By administering Imfinzi, we can expect to increase the success rate of surgery through neoadjuvant therapy and reduce the recurrence rate through adjuvant therapy, ultimately improving the survival rate of patients with muscle-invasive bladder cancer in Korea."