Adding visugromab to nivolumab raises pathologic complete response in small MIBC trial

Phase 1-2 · Nat Med · 2026-10-26. Number 4 in the UrologyWatch Top 5 for October 27, 2026.

In the nonrandomized, placebo-controlled phase 2a GDFATHER-NEO trial of 31 cisplatin-ineligible/refusing MIBC patients, neoadjuvant nivolumab plus the GDF-15 antibody visugromab yielded 33% pathologic complete response (5 of 15 evaluable) versus 8% (1 of 13) with nivolumab plus placebo, with no treatment-related delays to surgery.

Why it matters: Early signal in a small, nonrandomized exploratory trial suggests GDF-15 blockade may enhance neoadjuvant checkpoint inhibition in MIBC, warranting larger randomized confirmation.

Limitation: Small nonrandomized, sequentially allocated cohort (31 patients); not powered for definitive efficacy comparison.

Source: Nat Med · PubMed 42926233 · DOI 10.1038/s41591-026-04740-9

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