Press Release

New Treatment Approach Improves Survival and Reduces Recurrence Risk for Patients With Muscle-Invasive Bladder Cancer

New England Journal of Medicine study led by Mount Sinai investigator suggests a new perioperative treatment approach may represent the first major advance for this cancer in decades

New York, NY
(July 24, 2026)

Researchers have found that a combination of enfortumab vedotin and pembrolizumab helps patients with muscle-invasive bladder cancer live longer while reducing the risk that their cancer will return after surgery, according to an international phase 3 clinical trial published in The New England Journal of Medicine (DOI: 10.1056/NEJMoa2601486).

Bladder cancer is the sixth most common cancer in the United States. The American Cancer Society estimates that nearly 85,000 Americans will be diagnosed with the disease this year. About one in four bladder cancers are muscle-invasive, an aggressive form of the disease that carries a high risk of recurrence and spread to other parts of the body.

The phase 3 study (EYNOTE-B15/EV-304) was led by bladder cancer expert Matthew D. Galsky, MD, Lillian and Henry M. Stratton Professor of Cancer Medicine at the Icahn School of Medicine at Mount Sinai and Deputy Director of the Mount Sinai Tisch Cancer Center.

The trial compared a treatment combination of enfortumab vedotin and pembrolizumab with standard cisplatin-based chemotherapy, which has been the main treatment before bladder removal surgery for more than 20 years. Enfortumab vedotin is an antibody-drug conjugate that targets Nectin-4, a protein commonly found on bladder cancer cells. Pembrolizumab is an immunotherapy (PD-1 inhibitor). The PD-1 inhibitor helps the immune system recognize and attack cancer cells.

Researchers found that patients who received the newer treatment were significantly less likely to experience cancer progression, recurrence, or death. Two years after treatment began, nearly 80 percent of patients who received enfortumab vedotin and pembrolizumab remained free of disease progression, recurrence, or death, compared with 66 percent of those who received standard chemotherapy.

The study also showed that patients who received enfortumab vedotin plus pembrolizumab were more likely to have no detectable cancer at the time of surgery (a pathologic complete response).

“Patients with muscle-invasive bladder cancer have relied on essentially the same presurgery treatment approach for decades,” said Dr. Galsky. “This study demonstrates that enfortumab vedotin and pembrolizumab can provide better outcomes than standard cisplatin-based chemotherapy, reducing the risk that cancer will return or spread after surgery. These findings represent a major step forward and are likely to change the standard of care for patients around the world.”

The randomized phase 3 trial enrolled 808 patients at 158 sites worldwide. Participants were randomly assigned to receive either enfortumab vedotin plus pembrolizumab before and after surgery or standard cisplatin-based chemotherapy before surgery.

Researchers found that patients receiving enfortumab vedotin plus pembrolizumab had a 47 percent lower risk of cancer progression, recurrence, or death. More than half of patients receiving the newer treatment had no detectable cancer in tissue removed during surgery, compared with about one-third of patients receiving standard chemotherapy.

“These results build on earlier successes of this treatment combination in advanced bladder cancer and show that it can help patients with earlier-stage disease as well,” said Dr. Galsky. “Our goal is to give more patients the chance for long-term survival and potentially cure their disease.”

The researchers note that the treatment was associated with higher rates of side effects than standard chemotherapy, highlighting the importance of careful monitoring and management by experienced cancer care teams.

Based on the results of this study, on July 10, 2026, the Food and Drug Administration approved pembrolizumab in combination with enfortumab vedotin as perioperative treatment expanding the label from cisplatin-ineligible patients to all patients with MIBC who are candidates for cystectomy.

The study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., in collaboration with Astellas Pharma Inc. and Seagen Inc.

Full study: https://cme.nejm.org/weekly/10.1056/NEJMcme2601486

About the Icahn School of Medicine at Mount Sinai

The Icahn School of Medicine at Mount Sinai is internationally renowned for its outstanding research, educational, and clinical care programs. It is the sole academic partner for the seven member hospitals* of the Mount Sinai Health System, one of the largest academic health systems in the United States, providing care to New York City’s large and diverse patient population.

The Icahn School of Medicine at Mount Sinai offers highly competitive MD, PhD, MD-PhD, and master’s degree programs, with enrollment of more than 1,200 students. It has the largest graduate medical education program in the country, with more than 2,700 clinical residents and fellows training throughout the Health System. The Graduate School of Biomedical Sciences offers 12 degree-granting programs, conducts innovative basic and translational research, and trains more than 470 postdoctoral research fellows.

Ranked 11th nationwide in National Institutes of Health (NIH) funding, the Icahn School of Medicine at Mount Sinai is among the 90th percentile of U.S. private medical schools in Sponsored Programs Direct Expenditures per Principal Investigator, according to the Association of American Medical Colleges. More than 6,900 scientists, educators, and clinicians work within and across dozens of academic departments and multidisciplinary institutes with an emphasis on translational research and therapeutics. Through Mount Sinai Innovation Partners (MSIP), the Health System facilitates the real-world application and commercialization of medical breakthroughs made at Mount Sinai.

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* Mount Sinai Health System member hospitals: The Mount Sinai Hospital; Mount Sinai Brooklyn; Mount Sinai Morningside; Mount Sinai Queens; Mount Sinai South Nassau; Mount Sinai West; and New York Eye and Ear Infirmary of Mount Sinai.

About the Mount Sinai Health System

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with 48,000 employees working across seven hospitals, more than 400 outpatient practices, more than 600 research and clinical labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time—discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.

Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 9,000 primary and specialty care physicians and 10 free-standing joint-venture centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida. Hospitals within the System are consistently ranked by Newsweek’s^® “The World’s Best Smart Hospitals, Best in State Hospitals, World Best Hospitals and Best Specialty Hospitals” and by U.S. News & World Report's^® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report^® “Best Hospitals” Honor Roll for 2025-2026.

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