MRK Stock Gains After CHMP Backs Keytruda Combo for Bladder Cancer
Shares of Merck MRK rose nearly 6% on Friday after the company announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approval of the combination of two blockbuster drugs for certain patients with muscle-invasive bladder cancer (MIBC).
The CHMP recommended the use of Keytruda plus Pfizer PFE/Astellas Pharma’s ALPMY Padcev as perioperative treatment for adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy. If approved, the regimen would be used before surgery and continued after radical cystectomy.
The positive opinion will now be reviewed by the European Commission, with a final decision expected in third-quarter 2026. If approved, the Keytruda-Padcev regimen could become the first PD-1 inhibitor plus antibody-drug conjugate (ADC) combination available in the European Union for this indication. The regimen was approved by the FDA for the same indication in November 2025.
The CHMP’s opinion is backed by data from the phase III KEYNOTE-905 study, which evaluated the Keytruda-Padcev combination against surgery in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. The regimen demonstrated statistically significant and clinically meaningful improvements across several endpoints, including event-free survival, overall survival and pathologic complete response.
Merck’s Stock Performance
Per Merck, the regimen targets an underserved patient population with significant unmet need. The standard of care for patients with MIBC has been neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.
Shares of the company likely rose due to the regimen’s significant commercial potential in this patient population. The approval could further expand Keytruda’s presence in earlier-stage bladder cancer treatment.
Year to date, the stock has risen 16% against the industry’s nearly 1% decline.
Image Source: Zacks Investment Research
Merck, Pfizer Target Broader MIBC Population
Merck is working with Pfizer/Astellas to further expand the Padcev-Keytruda combination into broader bladder cancer populations. An FDA filing is currently under review for the regimen in cisplatin-eligible patients with MIBC. A final decision is expected on Aug. 17, 2026.
Approval in cisplatin-eligible MIBC would expand the label of both drugs to treat patients regardless of cisplatin eligibility. The Keytruda plus Padcev regimen also has the potential to become the new standard of care for MIBC, irrespective of cisplatin eligibility.
