Avelumab (anti-PD-L1) plus ddMVAC nets 58% pCR pre-cystectomy and 87% 3-yr OS in muscle-invasive bladder cancer

Phase 2 AURA trial (NCT03674424) enrolled 137 non-metastatic MIBC patients slated for radical cystectomy: cisplatin-eligible cases got neoadjuvant avelumab with either ddMVAC (n = 38) or gem-cis (n = 36), while cisplatin-ineligible received avelumab ± paclitaxel-gemcitabine (A n = 28; PG-A n = 28). Pathologic complete response (ypT0/Tis N0) reached 58% with ddMVAC-A and 53% with GC-A, dwarfing 14% with PG-A and 32% with avelumab alone. Three-year OS was 87% vs 67% (ddMVAC-A vs GC-A) and ~45% in ineligible arms. Grade 3–4 treatment-related AEs occurred in 38% overall; no new safety signals emerged, supporting tolerability of the chemo-IO combos.

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