Tremelimumab in Advanced Urothelial Carcinoma Patients Who Have Failed First-Line Platinum-Based Chemotherapy


Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

Tremelimumab is an immunotherapy treatment that helps the immune system recognize and attack cancer cells.

In a phase II trial designed to evaluate the benefit of Tremelimumab as monotherapy in 32 urothelial cancer patients whose disease has progressed on platinum-based treatment. 18.8% of patients responded to the drug, with 6.3% experiencing a complete remission of the disease. At 12 months 21.9% of patients had their disease controlled.  Tremelimumab was well tolerated.


Patients with advanced urothelial cancer who fail platinum-based therapy have a poor prognosis and limited treatment options. Tremelimumab is an antibody which demonstrated durable response in metastatic melanoma. This is the first study to report the efficacy and safety of Tremelimumab in urothelial cancer.


In 32 evaluable patients with metastatic urothelial cancer, 18.8% of patients responded to the treatment, including complete remission in 2 patients. Stable disease of ≥12 months was reported in 1 patient (3.1%). Overall, Tremelimumab was generally well tolerated; safety results were consistent with the known safety profile.


Tremelimumab monotherapy demonstrated clinical activity and durable responses in patients with metastatic urothelial cancer. This study is the first in which complete remission has been observed with Tremelimumab as a single agent in urothelial cancer.

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About Bladder Cancer

The bladder is a hollow organ with muscular walls where the body stores urine before it leaves the body.

Urine is the liquid waste made by the kidneys. The urine is carried to the bladder through ureters. When you go to the bathroom, the muscles in bladder will contract and they then push urine out through a tube called the urethra.

When cells of the bladder grow uncontrolled, they can become bladder cancer. A person with bladder cancer will usually have one or more tumors in his/her bladder.

The bladder wall has many layers, made up of different types of cells. Most bladder cancers start in the inside lining of the bladder.

Stage 4 bladder cancer

Bladder cancer worsens when it grows into or through other layers of the bladder wall. The cancer may grow outside the bladder into tissues nearby.

Bladder cancer may spread to lymph nodes nearby and the bones, the lungs or the liver and other parts of the body. When this happens, the cancer is called “Stage 4 metastatic bladder cancer”. With Non-muscle invasive bladder cancer, NMIBC, the tumor will not have spread outside the bladder as the bladder muscle is not involved.

Bladder cancer risk factors

  • Smoking – the cause of half of all bladder tumors
  • Exposure to chemicals used to make plastics, paints, textiles, leather and rubber
  • Genes / Family history
  • Certain types of infections
  • Patients with other cancers, such as lymphomas and leukemia, who receive treatment with Cyclophosphamide


Some people may have symptoms while others may feel nothing at all.

Some symptoms should never be ignored, such as blood in the urine or frequent and urgent urination. You need to talk to an urologist if you have any symptoms.

  • Blood in the urine – which is the most common symptom
  • Frequent and urgent urination
  • Pain when passing urine
  • Pain in the lower abdomen
  • Back pain

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