FDA Grants Priority Review to AstraZeneca’s Imfinzi for Muscle-Invasive Bladder Cancer

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The FDA has granted Priority Review designation to AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) to treat muscle-invasive bladder cancer (MIBC). According to the company, the sBLA is supported by data from the Phase III NIAGARA trial, which demonstrated that perioperative Imfinzi, in combination with neoadjuvant chemotherapy and as adjuvant monotherapy, significantly reduced the risk of disease progression, recurrence, or death compared to standard neoadjuvant chemotherapy with radical cystectomy alone.¹

“New options for muscle-invasive bladder cancer are vital because nearly half of patients will see their cancer return or progress despite undergoing curative-intent treatment, including removal of their bladder. Today’s Priority Review designation recognizes the urgent need for new options for these patients and the potential of Imfinzi to transform the standard of care as the first and only perioperative immunotherapy regimen to delay recurrence and extend survival in this setting,” said Susan Galbraith, EVP, oncology R&D, AstraZeneca, in a press release.

The randomized, open-label, multi-center, global NIAGARA trial is evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. As part of the trial, 1,063 patients were randomly assigned to receive Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by Imfinzi, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. Currently, 192 centers across 22 countries in North America, South America, Europe, Australia, and Asia are participating in the trial. The two primary endpoints are event-free survival (EFS) pathologic complete response, while secondary endpoints include overall survival (OS) and safety.

Results found that Imfinzi demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death. At the time of the data readout, the estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. After two years of treatment, around 67.8% of patients treated with the Imfinzi regimen were event-free at two years compared to 59.8% in the comparator arm.1 Further, the OS rate after one year was 89.5% for the Imfinzi group and 86.5% for the chemotherapy group, while at two years, the Imfinzi group demonstrated an 82.2% OS rate compared to 75.2% for the chemotherapy group.

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Additionally, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone. Grade 3 and 4 adverse events occurred in 69% of patients treated with Imfinzi and 68% of patients treated with neoadjuvant chemotherapy.²

According to AstraZeneca, bladder cancer is the ninth most common form of the disease in the world, with more than 614,000 patients diagnosed each year. Additionally, around 50% of patients who undergo bladder removal surgery experience disease recurrence.¹

“Neoadjuvant chemotherapy with bladder removal has been the mainstay of treatment for patients with muscle-invasive bladder cancer for nearly twenty years; however, half of patients still go on to suffer a devastating recurrence. Adding durvalumab before and after surgery significantly reduced the chance of recurrence and extended survival, a significant advance with the potential to transform the standard of care for these patients who desperately need better outcomes,” said Thomas Powles, MD, director, Barts Cancer Centre (QMUL), London, UK, principal investigator, NIAGARA trial, in a press release.

A decision on the sBLA is expected by the FDA in the second quarter of next year.¹

References

1. Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer. AstraZeneca. December 6, 2024. Accessed December 6, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-granted-priority-review-in-the-us-for-patients-with-muscle-invasive-bladder-cancer.html

2. Imfinzi perioperative regimen reduced the risk of recurrence by 32% and the risk of death by 25% vs. neoadjuvant chemotherapy alone in muscle-invasive bladder cancer in the NIAGARA Phase III trial. AstraZeneca. September 15, 2024. Accessed December 6, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-perioperative-regimen-reduced-risk-recurrence-by-32-risk-death-by-25-vs-neoadjuvant-chemotherapy-alone-in-mibc-niagara-phase-iii-trial.html