AstraZeneca PLC (AZN,AZN.L,ZEG.DE,AZN.ST) announced that its IMFINZI (durvalumab), in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy, has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).
The FDA approval was based on the positive results from the POTOMAC Phase 3 trial of the IMFINZI (durvalumab) combination in NMIBC.
In the Phase 3 POTOMAC trial, IMFINZI demonstrated positive results, and, notably, one year of IMFINZI added to BCG induction and maintenance therapy resulted in a statistically significant and clinically meaningful improvement in disease-free survival (DFS) for patients with NMIBC compared with BCG treatment alone.
Notably, with a median follow-up of more than 5 years (60.7 months), the IMFINZI regimen showed a 32% reduction in the risk of high-risk disease recurrence or death compared with the comparator arm.
The safety and tolerability of IMFINZI plus BCG induction and maintenance therapy were consistent with the known safety profiles of the individual medicines, with no new safety signals identified, according to the company.
Neal Shore, Head of the Carolina Urologic Research Centre and co-principal investigator in the trial, said, "The durvalumab plus BCG regimen is the first new therapy approved in over 30 years for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer."
The company estimated that in 2024, over 31,000 people in the US were treated for high-risk NMIBC, a curative-intent setting where the standard of care is tumour resection followed by BCG treatment directly into the bladder. Up to 80% of high-risk patients experience disease recurrence within five years of treatment.
In addition, regulatory submissions based on the POTOMAC results are under review in the European Union (EU) and Japan.
AZN has traded between $137.22 and $212.71 over the last year. The stock closed Thursday's trade at $185.33, down 0.17%.
In the after-hours market, AZN is up 1.56% at $188.23.
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