NIAGARA Trial Discussion
AstraZeneca's NIAGARA trial, presented at #ESMO24, investigated the effects of adding durvalumab to the standard neoadjuvant chemotherapy (cisplatin and gemcitabine) followed by adjuvant durvalumab after cystectomy in patients with muscle-invasive bladder cancer (MIBC).
Key Results
Event-Free Survival (EFS) at 24 months:
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- Durvalumab Arm: 67.8%
- Comparator Arm: 59.8%
- Hazard Ratio (HR): 0.68
|
Overall Survival (OS) at 24 months:
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- Durvalumab Arm: 82.2%
- Comparator Arm: 75.2%
- Hazard Ratio (HR): 0.75
|
| Pathologic Complete Response (pCR) rate was higher in the durvalumab arm with a difference of about 10%. |
The results indicate a statistically significant improvement in both EFS and OS, suggesting that adding durvalumab to the standard chemotherapy regimen could become a new standard of care (SoC) in the peri-operative setting for MIBC.
Support from Key Opinion Leaders
"Practice Changing"
"New Standard of Care"
"Patients are living longer from earlier use of IO agents"
"NEW SOC"
"Exciting Results!"
Major Criticisms
Several experts have raised concerns about the NIAGARA trial, particularly focusing on the absence of post-recurrence data, which is critical for a comprehensive evaluation of the treatment's long-term efficacy and safety. Vinay Prasad MD MPH criticized the trial for not examining post-recurrence outcomes, labeling it a significant oversight that complicates scientific analysis. Timothée Olivier, MD further highlighted that the trial's enrollment in low- and middle-income countries, where access to best post-recurrence care is limited, might have skewed the positive overall survival (OS) results. Additionally, there is a call for better critical appraisal by publishers like NEJM before amplification of such studies. Sabine D. Brookman-May pointed out key unanswered questions regarding the necessity of adjuvant treatment in ypT0 patients and the role of circulating tumor DNA (ctDNA) in treatment decisions, as well as the potential for systemic therapy in bladder-sparing approaches. Collectively, these criticisms underscore the need for a more thorough analysis and reporting in future trials to make well-informed clinical decisions.
"I think this is a new low"
"No post-recurrence data is so concerning"
