New Protocol: Neoadjuvant Durvalumab with Dose-Dense MVAC for Bladder Cancer

The NEMIO study investigated neoadjuvant ddMVAC combined with durvalumab with or without tremelimumab in patients with muscle-invasive bladder cancer. The pathologic complete response rate was 49% with ddMVAC plus durvalumab and 47% with ddMVAC plus durvalumab and tremelimumab. While the addition of tremelimumab did not improve the pathologic complete response rate, it increased treatment-related toxicity.

Study

Randomized, noncomparative phase II trial [NCT03549715]

Newly diagnosed muscle-invasive bladder cancer (MIBC)

Neoadjuvant ddMVAC + durvalumab (n=60) vs ddMVAC + durvalumab + tremelimumab (n=59)

Efficacy

pCR: 48.70% vs 46.27% (ddMVAC + durvalumab vs. ddMVAC + durvalumab + tremelimumab)

2-yr EFS: 75% vs 77%

2-yr OS: 85% vs 88%

Safety

Grade >=3 TRAEs: 31.7% vs 52.5%:

Neutropenia (8.3% vs 16.9%), anemia (11.7% vs 8.5%), acute kidney injury (1.7% vs 5.1%), Febrile neutropenia (5.0% vs 3.4%)

Grade >=3 irAE: 1.7% vs 6.8%

J Clin Oncol 2026;44:1921-1932

Thibault C, Bennamoun M, Flechon A Neoadjuvant Durvalumab Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study

http://doi.org/10.1200/JCO-25-03045

Reviewed by Ulas D. Bayraktar, MD on Aug 13, 2026

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