According to the American Cancer Society, bladder cancer accounts for approximately 4% of all cancers in the United States, making it the fourth most common cancer in men and less common in women. The likelihood of men developing bladder cancer in their lifetime is about 1 in 28, while for women, the chance is about 1 in 89. A quarter of individuals diagnosed with bladder cancer have muscle-invasive bladder cancer (MIBC), which carries a higher risk of recurrence. This highlights the urgent need for advancements in treatment options.

Addressing this critical need, we will examine the findings of the NIAGRA Phase III trial, which have shown promising results. The trial indicates that Imfinzi (durvalumab) has demonstrated a significant improvement in event-free survival (EFS) and overall survival (OS) compared to neoadjuvant chemotherapy for patients with MIBC. Below is a concise overview of the study:

A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

Study Details | Source

  • Sponsor: AstraZeneca
  • A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
  • Interventions: Drug: Durvalumab, Drug: Cisplatin, Drug: Gemcitabine
  • Primary Outcomes Measures: Pathologic complete response (pCR) rates at time of cystectomy [Up to 6 months], Event-free survival (EFS) per central review defined as time from randomization to event [Up to 48 months]
  • Secondary Outcomes Measured: Proportion of patients who achieve <P2 at time of cystectomy [Time Frame: Up to 6 months], EFS at 24 months (EFS24) defined as time from randomization to event [Time Frame: Up to 24 months], Proportion of patients who undergo cystectomy [Time Frame: Up to 6 months], Overall survival rate at 5 years [Time Frame: Up to 60 months], PFS2 defined as time from randomization to event following subsequent therapy [Time Frame: Up to 84 months], Safety and Tolerability as evaluated by adverse events occurring throughout the study [Time Frame: Up to 84 months], Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) [Time Frame: Up to 12 months], Overall Survival [Time Frame: Up to 84 months], Metastasis-free survival per investigator assessment or local biopsy review. [Time Frame: Up to 48 months], Disease-specific survival per investigator assessment or local biopsy review. [Time Frame: up to 48 months], Disease-free survival [Time Frame: Up to 48 months]

Imfinzi was generally well-tolerated, and the safety profile of both Imfinzi and neoadjuvant chemotherapy was consistent with the known profiles of the individual medicines. The addition of Imfinzi did not lead to an increase in the discontinuation rate due to adverse events, nor did it compromise patients’ ability to complete surgery when compared to neoadjuvant chemotherapy alone.

Will the results of this trial impact the Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer: American Urological Association/American Society of Clinical Oncology/American Society for Radiation Oncology/Society of Urologic Oncology Clinical Practice Guideline? We value your input and encourage you to share your thoughts. Don’t forget to sign up for alerts and stay informed on the latest published guidelines and articles.

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