Hope for Bladder Cancer Patients: New Drug Combination Cuts Death Risk by 50% – A Google News Alert

Milan, Italy – In a stunning development poised to reshape the treatment landscape for muscle-invasive bladder cancer (MIBC), a new drug combination has demonstrated remarkable efficacy in patients who previously had limited options. Results from the Phase 3 KEYNOTE-905/EV-303 study, unveiled today at the ESMO Congress 2025, show that combining the immunotherapy drug pembrolizumab with the antibody-drug conjugate enfortumab vedotin significantly reduces the risk of recurrence and death. This is particularly crucial for the substantial number of patients ineligible for or refusing platinum-based chemotherapy, often due to pre-existing health conditions.

A Game Changer for Cisplatin-Ineligible Patients

For decades, the prognosis for MIBC patients unable to tolerate cisplatin – a common chemotherapy drug – has been bleak. “For decades, patients with muscle-invasive bladder cancer who were ineligible for treatment with cisplatin have had limited therapeutic options available, often resorting exclusively to surgery,” explains Dr. Giuseppe Procopio, Director of the Prostate Program at the IRCCS Foundation National Cancer Institute of Milan. The KEYNOTE-905/EV-303 study changes that narrative. The combination therapy, administered before and after radical cystectomy (surgical removal of the bladder), slashed the risk of new events by 60% and the risk of death by a remarkable 50% compared to surgery alone.

Understanding Muscle-Invasive Bladder Cancer & Why This Matters

Bladder cancer affects approximately 31,000 people in Italy alone each year, making it a significant public health concern. MIBC, specifically, is a particularly aggressive form of the disease where the tumor has grown into the muscular layer of the bladder wall. This deeper infiltration dramatically increases the risk of the cancer spreading to other parts of the body (metastasis). Traditionally, treatment has involved a multidisciplinary approach – surgery, chemotherapy, and sometimes radiation – but the effectiveness of chemotherapy is limited by its side effects and suitability for all patients.

Key Findings from the KEYNOTE-905/EV-303 Study

The study, involving 595 patients, compared three treatment arms. The most impactful results came from Arm C, which utilized perioperative (before and after surgery) treatment with pembrolizumab plus enfortumab vedotin. Here’s a breakdown of the key data:

• Event-Free Survival (EFS): The risk of cancer progression or recurrence was reduced by 60% (HR = 0.40). Median EFS was not yet reached in the combination therapy group, compared to 15.7 months in the surgery-only group.
• Overall Survival (OS): The risk of death was cut by 50% (HR = 0.50). Median OS was not reached in the combination group, versus 41.7 months in the surgery-only group.
• Pathological Complete Response (pCR): A stunning 57.1% of patients in the combination therapy arm achieved a pCR – meaning no cancer cells were found in the bladder after surgery – compared to just 8.6% in the surgery-only group.

Beyond the Numbers: A New Era of Hope

“More than 70% are disease-free after two years and potentially cured,” states Dr. Patrizia Giannatempo, Director of the Genitourinary Medical Oncology Departmental Structure at the IRCCS Foundation. “It is an unprecedented achievement in a population largely made up of patients ineligible for cisplatin, who have so far lacked effective treatment options.” While the combination therapy did result in more treatment-emergent adverse events (100% vs. 64.8%) and higher rates of grade ≥ 3 events (71.3% vs. 45.9%), the benefits appear to significantly outweigh the risks, particularly for a patient population with historically limited options. Skin reactions were the most common significant side effect.

This breakthrough isn’t just about extending lives; it’s about offering a chance at a better quality of life for those facing a challenging diagnosis. The KEYNOTE-905/EV-303 study represents a pivotal moment in bladder cancer treatment, and its findings are expected to rapidly influence clinical practice worldwide. For patients and their families, this news offers a powerful dose of hope and a renewed sense of possibility. Stay tuned to archyde.com for ongoing coverage of medical breakthroughs and health news that impacts your life.