Merck's Bladder Cancer Combo Therapy Just Changed The Game For Cisplatin-Ineligible Patients

The FDA just greenlit a major combo: KEYTRUDA + Padcev as the first-ever PD-1 inhibitor + ADC regimen for perioperative treatment of muscle-invasive bladder cancer patients who can’t take cisplatin.

Here’s why this matters:

The Clinical Win:

• 60% reduction in event-free survival risk vs surgery alone
• 50% boost in overall survival
• 57.1% pathologic complete response rate (compared to just 8.6% with surgery solo)
• Median follow-up: 25.6 months

The Unmet Need: Nearly half of bladder cancer patients relapse post-surgery, and a huge chunk can’t handle cisplatin chemo—until now.

The Catch: Adverse reactions hit 20%+ of patients. Serious immune-mediated events (pneumonitis, colitis, hepatitis) tracked with known PD-1 inhibitor profiles.

Market Context: KEYTRUDA is already a Merck cash cow—pulled in $8.1B sales last quarter (up 10% YoY). MRK stock closed Friday at $97.76, up 2.94%, trading in a $73-$105 range over the past year.

Bottom line: This approval could reshape treatment standards for thousands of patients annually and add more fuel to Merck’s oncology pipeline.