Bladder cancer will be diagnosed in approximately 77,000 people in the United States this year alone. The average age that patients are diagnosed with bladder cancer is 70 years, with 80% of these patients being former smokers. The most common type of bladder cancer is urothelial carcinoma, whereby cancer begins in the cells that line the bladder.
Urothelial carcinoma may involve parts of the kidney, bladder, and ureter (the tube that connects the kidney to the bladder). Urothelial carcinomas begin in the cells that line the particular organ in which the cancer develops. If detected and treated early, cure rates are high. However, once bladder cancer has spread outside of the bladder to distant sites in the body, effective treatment options remain limited, particularly if a patient experiences a cancer recurrence following prior therapies. Advanced bladder cancer refers to cancer that has spread outside the bladder to regional or distant sites in the body.
Because the majority of patients diagnosed with bladder cancer are elderly and/or former smokers, they are often too frail to be treated with the standard chemotherapy agent approved for the treatment of advanced stages of this disease, cisplatin. Patients who are not able to tolerate cisplatin may be treated with the chemotherapy agent carboplatin, which provides a median survival of approximately 9-10 months.
Keytruda (pembrolizumab) is a monoclonal antibody that helps to restore the body’s immune system in fighting cancer. It creates its anti-cancer effects by blocking a specific protein used by cancer cells called PD-L1, to escape an attack by the immune system. Once PD-L1 is blocked, cells of the immune system are able to identify cancer cells as a threat, and initiate an attack to destroy the cancer. Keytruda is approved for the treatment of certain types of metastatic melanoma and head and neck cancer.
About The KEYNOTE-045 Clinical Study
The KEYNOTE-045 clinical study was designed to compare Keytruda to standard chemotherapy as selected by the treating physician in patients with advanced urothelial cancer that had recurred or progressed following platinum-based chemotherapy. Overall 542 patients were treated with Keytruda alone or investigator-choice of Taxol, Taxotere, or vinflunine and directly compared. Merck, the study sponsor has announced that Keytruda was determined to be superior to investigator choice chemotherapy and the independent Data Monitoring Committee has recommended that the trial be stopped early because Keytruda has been demonstrated to prolong patient survival.
Reference: Merck. (2016.) Merck’s KEYNOTE-045 studying keytruda in advanced bladder cancer 9urothelial cancer) meets Primary Endpoint and stops early. [Press release.] Can be retrieved from: http://investors.merck.com/investors/financial-news/press-release-details/2016/Mercks-KEYNOTE-045-Studying-KEYTRUDA-pembrolizumab-in-Advanced-Bladder-Cancer-Urothelial-Cancer-Meets-Primary-Endpoint-and-Stops-Early/default.aspx
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