Merck Stock Gains On Positive EU Opinion For Cancer Therapy

• EU regulators backed the combo based on strong Phase 3 data showing improvements across survival and tumor response outcomes.
• KEYTRUDA + Padcev significantly reduced the risk of disease progression and death versus surgery alone in the trial.
• If approved, the regimen would become a first-of-its-kind perioperative treatment option for high-risk bladder cancer patients in Europe.

Merck (MRK) shares rose nearly 5% in early trade on Friday after the company said a European medicines committee issued a positive opinion for its Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) combination.

The treatment is for adults with resectable muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy.

The decision now moves to the European Commission for final review, with a ruling expected by the third quarter this year for the EU and other European markets.

KEYTRUDA is a PD-1 immunotherapy that helps the body’s immune system recognize and attack cancer cells more effectively.

Aimed At Patients With Limited Treatment Options

If approved, this would become the first PD-1 inhibitor plus antibody-drug conjugate combination available in the European Union (EU) for this type of bladder cancer.

The recommendation is based on Phase 3 KEYNOTE-905 trial results, which showed the Keytruda + Padcev regimen significantly improved outcomes compared to surgery alone, including better survival and higher rates of complete tumor response.

Merck said the data highlight a major unmet need, as patients who cannot receive cisplatin-based chemotherapy currently have limited treatment options and face a high risk of disease recurrence.

MRK Sees Higher Tumor-Free Rates

The Keytruda + Padcev combination significantly outperformed surgery alone in the trial. It reduced the risk of cancer progression or recurrence by about 60% and cut the risk of death by around 50%.

More patients on the combo showed no detectable cancer after treatment compared to surgery alone (57% vs 9%).

MRK Stock: What Retail Sentiment Says

On Stocktwits, retail sentiment is “neutral” and it has remained unchanged over the past 24 hours. Message volume is “high” and also stayed the same over the past one day.

MRK Stock has risen nearly 59% in the past 12 months.

For updates and corrections, email newsroom[at]stocktwits[dot]com.