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• W4251612516 abstract "Neoadjuvant cisplatin-based chemotherapy (NAC) is the standard of care in muscle-invasive bladder cancer. However, 60-75% patients (pts) have residual disease after NAC. The efficacy of immune checkpoint inhibitors (ICI) in metastatic MIBC suggests that a combination of NAC + ICI could increase the rate of pCR. ddMVAC is the most commonly used NAC regimen in Europe. We decided to evaluate the safety and efficacy of ddMVAC + durvalumab (D) +/- tremelimumab (T) in a phase I/II trial. NEMIO is an open-label randomized phase I/II trial assessing ddMVAC + D (arm A) +/- T (arm B) in the neoadjuvant setting. Pts received 4 cycles of ddMVAC every 2 weeks (w) + 2 cycles of D 1500 mg +/- T 75 mg every 4 w. Cystectomy was performed 4-8 w after the last dose of ddMVAC. The safety run-in phase was planned to include 6 pts in each arm to evaluate the toxicity. The primary endpoint was the dose limiting toxicity (DLT) defined as the rate of grade ≥ 3 treatment-related adverse events (TRAE) up to 3 months after cystectomy. The phase II cohort was planned to expand each arm to a maximum of 60 pts. The co-primary endpoints of the phase II were G≥3 TRAE and pCR. A Bayesian stopping rule was used to monitor toxicity in real time in both phases. We present here the results of the safety run-in phase. Twelve pts have been enrolled between Dec 2018 and July 2019 in 6 centers. The median age was 59.5 y with predominant ECOG performance status 0 (n=11/12). 3 pts discontinued the treatment due to chemo related toxicities: 2 pts didn’t receive the last cycle of ddMVAC due to G3 fatigue (1 in each arm) and 1 pt stopped after 2 cycles of ddMVAC and 1 cycle of D+T due to G3 renal insufficiency (RI) in arm B. DLT occurred in 2 pts (1 in each arm): G3 acute RI and G3 thrombopenia. No immune-related adverse events have been reported at time of analysis. The G≥3 TRAE were: hematological (n=4), fatigue (n=2), anal abscess (n=1), RI (n=1). All pts underwent cystectomy. A pCR was observed in 8 pts (4 in each arm) and downstaging to ≤ pT1 in 9 pts. Based on the first 12 pts included, the safety of ddMVAC + D +/- T is acceptable. The phase II is ongoing and the recruitment is expected to be completed in 2022." @default.
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• W4251612516 date "2020-09-01" @default.
• W4251612516 modified "2023-10-18" @default.
• W4251612516 title "1059P NEMIO: A randomized phase I-II trial evaluating efficacy and safety of dose dense MVAC (ddMVAC) + durvalumab +/- tremelimumab as neoadjuvant treatment in patients with bladder muscle-invasive urothelial carcinoma" @default.
• W4251612516 doi "https://doi.org/10.1016/j.annonc.2020.08.1179" @default.
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