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.

The agency issued a PDUFA target action date of June 14, 2027.

Long-term QUILT-3.032 findings show durable responses with Anktiva plus BCG in BCG-unresponsive NMIBC, with an estimated 84.2% cystectomy-free survival at 3 years.