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On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) to be used with gemcitabine and cisplatin as a first treatment, followed by durvalumab alone as a follow-up treatment after surgery, for patients with muscle-invasive bladder cancer (MIBC).
he effectiveness was evaluated in NIAGARA (NCT03732677), a Phase III trial where 1,063 patients who could have radical cystectomy and had not received any previous treatment for bladder cancer were randomly assigned to either get neoadjuvant durvalumab with chemotherapy, followed by adjuvant durvalumab after surgery, or just neoadjuvant chemotherapy followed by surgery.
Patients were randomly assigned (1:1) to either get neoadjuvant durvalumab along with chemotherapy, followed by adjuvant durvalumab after surgery, or to receive only neoadjuvant chemotherapy followed by surgery.
The primary efficacy endpoint was event-free survival (EFS) assessed by blinded independent central review. Overall survival (OS) constituted a supplementary effectiveness outcome. During a predetermined interim analysis, the trial exhibited a statistically significant enhancement in event-free survival (EFS) and overall survival (OS).
The average time without events (EFS) was not reached in the durvalumab plus chemotherapy group, but it was 46.1 months in the chemotherapy group, with a hazard ratio of 0.68 and a very low p-value. The average overall survival was also not reached in either group, with a hazard ratio of 0.75 and a p-value of 0.0106. The median overall survival was not attained in either group (hazard ratio 0.75 [95% CI: 0.59, 0.93]; two-sided p-value=0.0106).
Adverse effects aligned with previous experiences involving durvalumab and platinum-based chemotherapy.
The advised dosage of durvalumab for patients weighing ≥30 kg is 1,500 mg every 3 weeks in conjunction with chemotherapy (neoadjuvant treatment) and 1,500 mg as a monotherapy every 4 weeks (adjuvant treatment). The advised dosage of durvalumab for patients weighing less than 30 kg is 20 mg/kg in conjunction with chemotherapy every three weeks (neoadjuvant treatment) and 20 mg/kg as a monotherapy every four weeks (adjuvant treatment). Treatment should persist until disease development that prevents definitive surgery, recurrence, severe toxicity, or a maximum of 8 cycles post-surgery.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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