CORE-001 Trial Participation and Eligibility Criteria

Topline results are expected in November 2026 ahead of a planned sBLA submission.

In a POTOMAC subgroup analysis, durvalumab plus BCG reduced the risk of high-risk recurrence or death by 44% vs BCG alone in patients with papillary-only, BCG-naive NMIBC.

Andrea Necchi, MD, discusses how results from the CA017-078 trials compares with other perioperative immunotherapy trials in muscle-invasive bladder cancer.

Final phase 3 CA017-078 data show perioperative nivolumab plus GC did not significantly improve pCR (39.1% vs 29.6%) or EFS (HR, 0.94) vs GC alone in MIBC.

Perioperative durvalumab (Imfinzi) plus neoadjuvant enfortumab vedotin-ejfv (Padcev) cut the risk of EFS events by 49% and death by 42% in cisplatin-ineligible MIBC.

At a median follow-up of 60.9 months, median EFS was 74.1 months in the pembrolizumab arm and not reached in the placebo arm.

Michael S. Cookson, MD, MMHC, FACS, discusses how Anktiva’s expanded FDA approval may broaden bladder-preserving treatment options for BCG-unresponsive papillary-only NMIBC.

This approval expands the perioperative use of pembrolizumab plus enfortumab vedotin to all patients with MIBC, regardless of cisplatin eligibility.