Durvalumab regimen improves outcomes in muscle-invasive bladder cancer
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Key takeaways:
- Durvalumab in the neoadjuvant and adjuvant setting conferred benefit in EFS and OS.
- Use of durvalumab did not increase grade 3 or grade 4 treatment-related adverse events.
Use of durvalumab before and after radical cystectomy improved outcomes for patients with muscle-invasive bladder cancer, according to results of the randomized phase 3 NIAGARA trial.
The regimen significantly extended EFS and OS, findings presented at ESMO Congress showed.
Patients with muscle-invasive bladder cancer who are eligible for cisplatin often receive neoadjuvant chemotherapy followed by radical cystectomy.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
Researchers conducted the NIAGARA trial to assess use of durvalumab with neoadjuvant chemotherapy, followed by radical cystectomy and adjuvant durvalumab.
The analysis included 1,063 patients with muscle-invasive disease, defined as cT2-T4aN0/1M0.
Researchers assigned 533 patients to 1,500 mg neoadjuvant durvalumab IV every 3 weeks plus neoadjuvant chemotherapy with cisplatin and gemcitabine every 3 weeks for four cycles, followed by radical cystectomy, followed by adjuvant therapy with 1,500 mg durvalumab every 4 weeks for eight cycles. The other 530 patients received neoadjuvant chemotherapy alone followed by radical cystectomy.
EFS and pathologic complete response served as dual primary endpoints. OS served as a secondary endpoint.
At ESMO, researchers presented EFS and OS results from a pre-planned interim analysis.
Median follow-up was 42.3 months (range, 0.03-61.3).
A higher percentage of patients assigned durvalumab achieved 24-month EFS (67.8% vs. 59.8%; HR = 0.68; 95% CI, 0.56-0.82). A 24-month OS analysis also favored the durvalumab group (82.2% vs. 75.2%; HR = 0.75; 95% CI, 0.59-0.93).
The majority of patients in the durvalumab group and no-durvalumab group underwent radical cystectomy (88% vs. 83.2%), and 383 of 469 patients assigned the durvalumab regimen began adjuvant durvalumab.
A similar percentage of patients in the durvalumab and no-durvalumab groups developed grade 3 or grade 4 treatment-related adverse events (40.6% vs. 40.9%) and died due to treatment-related causes (0.6% in each group).
Adverse events prompted 8% of patients to discontinue adjuvant durvalumab.
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Powles TB, et al. Abstract LBA5. Presented at: European Society for Medical Oncology Congress; Sept. 13-17, 2024; Barcelona, Spain.
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