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A Breakthrough Combination Therapy for Advanced Bladder Cancer

Bladder Cancer Stages Vector illustration

Bladder cancer is one of the most common and aggressive types of cancer, affecting about 83,000 people in the US every year1. Bladder cancer occurs when abnormal cells grow and multiply in the lining of the bladder, the organ that stores urine. Bladder cancer can spread to other parts of the body, such as the lymph nodes, bones, lungs, and liver, making it harder to treat.

Bladder cancer is classified into two types: non-muscle invasive and muscle invasive. Non-muscle invasive bladder cancer is confined to the inner layer of the bladder wall, while muscle invasive bladder cancer has invaded the muscle layer or beyond. Bladder cancer is also classified into four stages, depending on how far it has spread: stage I, II, III, and IV. Stage IV is the most advanced and serious stage, where the cancer has spread to distant organs or tissues.

The treatment options for bladder cancer depend on the type and stage of the cancer, as well as the patient’s overall health and preferences. The main treatments include surgery, chemotherapy, radiation therapy, immunotherapy, and targeted therapy. However, not all patients respond well to these treatments, and some may experience severe side effects or recurrence. Therefore, there is an unmet need for more effective and tolerable therapies for bladder cancer, especially for patients with advanced or metastatic disease.

One of the most promising therapies for advanced bladder cancer is the combination of PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab). PADCEV is an antibody-drug conjugate (ADC), which is a type of targeted therapy that delivers a potent drug directly to the cancer cells, while sparing the normal cells. PADCEV consists of an antibody that recognizes a protein called Nectin-4, which is highly expressed on bladder cancer cells, and a drug that kills the cells once inside.

KEYTRUDA is an immunotherapy, which is a type of therapy that stimulates the body’s own immune system to fight the cancer. KEYTRUDA blocks a protein called PD-1, which is a checkpoint that prevents the immune system from attacking the cancer cells. By blocking PD-1, KEYTRUDA unleashes the immune system to recognize and destroy the cancer cells.

The combination of PADCEV and KEYTRUDA was approved by the Food and Drug Administration (FDA) on December 15, 2023, as the first and only ADC plus PD-1 therapy to treat patients with locally advanced or metastatic urothelial carcinoma, which is the most common type of bladder cancer, who are ineligible for cisplatin-containing chemotherapy2.

The approval was based on the results of a clinical trial called EV-302/KEYNOTE-869, which involved 608 patients with previously untreated advanced urothelial carcinoma. The trial compared the combination of PADCEV and KEYTRUDA with standard of care platinum-based chemotherapy. The trial found that the combination of PADCEV and KEYTRUDA nearly doubled the median overall survival compared to chemotherapy, which was 23.5 months versus 12.9 months, respectively.

The trial also found that the combination of PADCEV and KEYTRUDA significantly improved the objective response rate, which was the percentage of patients who had a partial or complete shrinkage of their tumors, compared to chemotherapy, which was 71% versus 36%, respectively. The trial also showed that the combination of PADCEV and KEYTRUDA was generally well tolerated, with manageable side effects3.

The approval of PADCEV and KEYTRUDA marks a major milestone in the treatment of advanced bladder cancer, as it offers a new option for patients who have limited choices and poor outcomes. The combination of PADCEV and KEYTRUDA is the first and only ADC plus PD-1 therapy to treat advanced bladder cancer, and it has shown remarkable results in terms of survival and response. The combination of PADCEV and KEYTRUDA is a breakthrough combination therapy that has the potential to change the standard of care and improve the quality of life for patients with advanced bladder cancer.

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Written by 365PodCast

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