Durvalumab Approved for Muscle Invasive Bladder Cancer
Expert Perspectives · Lyn Brook · 2025-04-01
The FDA has granted approval to durvalumab (Imfinzi®, AstraZeneca) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy. This approval is indicated for adult patients with muscle-invasive bladder cancer (MIBC).
Why This Approval Matters
This approval provides a new treatment paradigm for patients with MIBC, offering both neoadjuvant and adjuvant therapy options. The combination of durvalumab with standard chemotherapy, followed by maintenance durvalumab, represents a significant advancement in the treatment of MIBC, potentially improving outcomes for patients undergoing radical cystectomy.
Breaking Down the NIAGARA Trial
The efficacy of durvalumab was evaluated in the NIAGARA trial (NCT03732677), an open-label, multicenter phase 3 study. The trial enrolled 1,063 patients with MIBC who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Patients were randomized 1:1 to receive either:
- Neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery
- Neoadjuvant chemotherapy alone followed by surgery
The primary efficacy end point included event-free survival (EFS) by blinded independent central review (BICR), with a secondary end point of overall survival (OS).
Statistically significant improvements were demonstrated for both EFS and OS. Median EFS was not reached in the durvalumab arm compared with 46.1 months in the chemotherapy arm. Median OS was not reached in either arm.
Managing Adverse Events
The safety profile observed in patients receiving durvalumab with platinum-based chemotherapy was consistent with previously reported experiences. Clinicians should monitor for immune-mediated adverse events and other side effects commonly associated with durvalumab and chemotherapy.
Clinical Implications
“Perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in EFS and OS as compared with neoadjuvant chemotherapy alone,” concluded Thomas Powles, MD, Director of Barts Cancer Institute, and colleagues in their published results of the NIAGARA trial.
Dosing and Administration
For patients ≥30 kg:
- Neoadjuvant: 1,500 mg durvalumab every three weeks with chemotherapy
- Adjuvant: 1,500 mg durvalumab every four weeks as a single agent
For patients <30 kg:
- Neoadjuvant: 20 mg/kg durvalumab every three weeks with chemotherapy
- Adjuvant: 20 mg/kg durvalumab every four weeks as single agent
Treatment should continue until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity, for a maximum of eight cycles after surgery.