PADCEV + Keytruda receives positive CHMP opinion for resectable MIBC

CAR-T Digest - August 2020

18 September 2026: PADCEV + Keytruda receives positive CHMP opinion for resectable MIBC

Astellas and MSD announced that PADCEV in combination with KEYTRUDA received a positive CHMP opinion for perioperative treatment of adults with resectable muscle-invasive bladder cancer, covering neoadjuvant treatment followed by adjuvant treatment after radical cystectomy
The opinion is based on the phase 3 EV-304/KEYNOTE-B15 trial, where perioperative PADCEV plus KEYTRUDA reduced the risk of disease recurrence, progression or death by 47% (HR=0.53) and reduced the risk of death by 35% (HR=0.65) versus neoadjuvant gemcitabine/cisplatin in cisplatin-eligible patients
The recommendation addresses a major unmet need in MIBC, where nearly half of patients experience recurrence within five years after neoadjuvant chemotherapy and surgery, while treatment options have historically differed according to cisplatin eligibility
PADCEV is a Nectin-4-directed ADC comprising an antibody linked to the microtubule inhibitor MMAE, while KEYTRUDA is a PD-1 inhibitor; together, the regimen combines targeted cytotoxic delivery with immune checkpoint blockade
Strategically, the positive opinion would expand PADCEV plus KEYTRUDA’s EU MIBC indication from the current cisplatin-ineligible population to adults with resectable MIBC regardless of cisplatin eligibility, potentially establishing a broader perioperative ADC-IO treatment approach in bladder cancer