Merck’s KEYTRUDA plus Padcev improves survival in bladder cancer study

RAHWAY, N.J. - Merck (NYSE:MRK), a prominent player in the pharmaceuticals industry with $63.62 billion in trailing twelve-month revenue, announced Tuesday that its Phase 3 KEYNOTE-905 trial showed significant survival benefits for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. According to InvestingPro analysis, Merck currently appears undervalued, supported by strong fundamentals including a healthy 77.41% gross profit margin.

The study evaluated KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) given before and after surgery, demonstrating statistically significant improvements in event-free survival, overall survival, and pathologic complete response rate compared to surgery alone. This development could further strengthen Merck’s market position, which already demonstrates solid financial health with an impressive "GREAT" rating according to InvestingPro’s comprehensive analysis of over 100 financial metrics.

This marks the first time a systemic therapy used before and after surgery has shown survival benefits in this specific patient population, which has historically had limited treatment options beyond surgery and faced high disease recurrence rates.

"There is a real and pressing need for more effective options for patients with bladder cancer who are ineligible for cisplatin-based treatment," said Dr. Marjorie Green, senior vice president at Merck Research Laboratories, in the press release statement.

The safety profile was consistent with the known profiles of each agent, with no new safety signals identified in the combination therapy.

KEYTRUDA plus Padcev is already approved for treating locally advanced or metastatic urothelial cancer in the U.S., European Union, Japan, and other countries. The companies plan to present detailed results at an upcoming medical meeting and share findings with regulatory authorities worldwide.

Muscle-invasive bladder cancer represents approximately 30% of all bladder cancer cases, and up to half of these patients are not eligible for cisplatin-based chemotherapy, which is the standard treatment alongside surgery.

The trial was conducted in collaboration with Pfizer (previously Seagen) and Astellas and continues to evaluate secondary endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone.

In other recent news, Merck & Co. reported its second-quarter 2025 earnings, revealing a robust performance in earnings per share (EPS) but falling short on revenue expectations. The company achieved an EPS of $2.13, surpassing the projected $2.03, while revenue came in at $15.8 billion, slightly below expectations. Additionally, Cantor Fitzgerald maintained its Neutral rating on Merck, citing growth challenges highlighted by a narrowed top-line guidance and a $3 billion restructuring program. Meanwhile, IO Biotech announced promising topline results from its pivotal Phase 3 trial of Cylembio, an investigational cancer vaccine, in combination with Merck’s KEYTRUDA for advanced melanoma patients. The trial demonstrated clinical improvement in progression-free survival compared to KEYTRUDA alone, although it narrowly missed statistical significance on the primary endpoint. Patients treated with the combination achieved a median progression-free survival of 19.4 months versus 11.0 months for those on KEYTRUDA monotherapy. These developments offer investors insights into the recent performance and strategic challenges facing both companies.

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