Natera社の血中循環腫瘍DNA（ctDNA）検査「Signatera」が、筋層浸潤性膀胱がん（MIBC）における術後アテゾリズマブ治療の適応判定用コンパニオン診断薬として、日本の医薬品医療機器総合機構（PMDA）から承認を取得した。

: To compare the efficacy and safety of three perioperative regimens for cisplatin-eligible muscle-invasive bladder cancer (MIBC) — enfortumab vedotin…

#ПациентскаИстория - От лечение към проследяване: историята на Джон и ролята на Signatera. На 66 години Джон получава диагноза мускулно-инвазивен рак на пикочния мехур. В този момент прогнозата, която...

Perioperative treatment with enfortumab vedotin plus pembrolizumab significantly boosts the survival of cisplatin-eligible patients with muscle-invasive bladder cancer.

Background: Muscle-invasive bladder cancer (MIBC) is treated with radical cystectomy or trimodality therapy (TMT), which yield comparable survival outcomes. Many patients undergoing TMT experience sig...

Natera has submitted Signatera to Japan's PMDA for approval as a companion diagnostic in muscle-invasive bladder cancer.

Neoadjuvant cisplatin-based chemotherapy followed by cystectomy is the established standard of care (SOC) for patients with resectable muscle-invasive bladder cancer (MIBC). More recently, the phase III KEYNOTE-905/EV-303 trial showed that those who are ineligible for or decline cisplatin-based regimens can derive substantial benefit from perioperative treatment with the nectin 4-targeted antibody–drug conjugate enfortumab vedotin (EV) plus the anti-PD-1 antibody pembrolizumab. Now, data from the phase III KEYNOTE-B15/EV-304 trial show that perioperative EV–pembrolizumab also improves the outcomes of patients with MIBC eligible for SOC therapy. A total of 808 patients were randomly allocated (1:1) to receive perioperative EV–pembrolizumab (4 cycles before radical cystectomy with pelvic lymph node dissection followed by 5 cycles of EV and 13 cycles of pembrolizumab) versus neoadjuvant chemotherapy (4 cycles of cisplatin–gemcitabine before surgery). A protocol amendment allowed adjuvant treatment with the anti-PD-1 antibody nivolumab in the chemotherapy group when clinically indicated, although only 7.8% received such treatment. Event-free survival (EFS) was the primary end point. Access options

Nature Reviews Clinical Oncology, Published online: 04 August 2026; doi:10.1038/s41571-026-01195-2Benefit from perioperative enfortumab vedotin–pembrolizumab in cisplatin-eligible MIBC

Matthew Galsky, MD, discusses data from the phase 3 KEYNOTE-B15/EV-304 study in MIBC.