The phase III CA017-078 (ENERGIZE) trial did not meet its co-primary endpoints of event-free survival (EFS) and pathological complete response (pCR) (OncoDaily) - Oct 23, 2026 - "Adding nivolumab to neoadjuvant gemcitabine–cisplatin, followed by radical cystectomy and adjuvant nivolumab, did not significantly improve either endpoint compared with neoadjuvant chemotherapy followed by radical cystectomy alone...There was no statistically significant improvement with the nivolumab-containing regimen (HR 0.94; 95.74% CI 0.71–1.25; P = 0.6697). Median EFS was not reached in the nivolumab arm and was 67.6 months in the chemotherapy-alone arm...pCR rates were 39.1% versus 29.6%, respectively. The adjusted difference was 9.5 percentage points (99.91% CI −2.6 to 21.6), which was not statistically significant."
P3 data • Bladder Cancer
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