Merck achieves historic milestone: FDA approves first combination of PD-1 inhibitor and ADC for bladder cancer

Merck has just received the green light from the FDA to market KEYTRUDA ( together with its subcutaneous version KEYTRUDA QLEX) combined with Padcev as a perioperative treatment for patients with invasive muscle bladder cancer who cannot receive cisplatin-based chemotherapy.

This is the first and only combination of its kind, marking a turning point in oncology. Invasive bladder cancer is aggressive —it penetrates the muscle wall— and nearly 50% of patients suffer recurrence even after surgery. Many are left with no options because they cannot tolerate cisplatin, creating a huge therapeutic gap.

The numbers that matter

The phase 3 trial KEYNOTE-905 ( median follow-up of 25.6 months ) revealed:

• 60% reduction in progression-free survival events vs surgery alone
• 50% improvement in overall survival
• 57.1% of complete pathological response rate vs 8.6% with surgery alone

Not everything is positive: adverse reactions in ≥20% of patients, serious immune-mediated events such as pneumonia, colitis, hepatitis typical of PD-1 inhibitors.

The business context

KEYTRUDA is already a money machine: $8.1 billion in sales Q3 2025, YoY growth of 10%. Merck's stock closed Friday at $97.76 (+2.94%), fluctuating between $73.31-$105.07 for the year.

Padcev comes from the alliance Astellas + Seattle Genetics (now Pfizer), expanding the immuno-oncology portfolio of the industry. This is the type of combo that reshape markets.