New Clinical Trial Sparks Hope for Those with Metastatic Urothelial Carcinoma

A clinical trial led by drug company G1 Therapeutics will look at a new combination of chemotherapy drugs to treat locally advanced or metastatic urothelial carcinoma (mUC).1

Bladder cancer is the 6th most common cancer in the United States. Experts predict that 84,000 people will be diagnosed with some form of bladder cancer in 2021. About 90 percent of all bladder cancer cases are urothelial carcinoma. Other names for the same cancer type are transitional cell carcinoma (TCC) and urothelial bladder cancer.1

Unfortunately, mUC often has a difficult prognosis. Currently, the overall survival rate 5 years after diagnosis is 5.5 percent. This rate has not changed in the past 25 years. In this time, researchers have been searching for new treatments. The clinical trial, called Preserve 3, may offer a new option for people with mUC.1

How will the clinical trial be performed?

Chemotherapy drugs work in many different ways. To treat cancer effectively, doctors often combine different drugs together. The Preserve 3 clinical trial will compare the usual mUC treatment with and without the drug Cosela (trilaciclib).1

The trial will include 2 groups of people:1,2

Control group – The people in this group will receive standard mUC therapy. This includes one dose of the chemotherapy drug gemcitabine and a platinum-based chemotherapy drug once every 21 days, along with a dose of the immunotherapy drug avelumab every 14 days.

Study group – The people in this group will receive the same therapy as those in the control group. However, they will also receive a dose of Cosela.

As of June 2021, researchers from G1 Therapeutics are enrolling people in the clinical trial. About 90 people with mUC will be enrolled, and the trial will continue for about 4 months. Researchers hope to publish the results midway through 2022.1

What is Cosela?

A common side effect of chemotherapy is myelosuppression. This is when the drug damages your bone marrow’s ability to make cells. These cells include:2

  • Red blood cells that carry oxygen
  • White blood cells that fight off infections
  • Platelets that form blood clots when you are hurt

Cosela is a type of drug known as a kinase inhibitor. It works to protect bone marrow cells from damage caused by chemotherapy by blocking certain proteins that tell cancer cells to grow. This is important because myelosuppression makes it hard for the body to fight off cancer.2

Cosela is already approved for people with small cell lung cancer (SCLC) who are receiving chemotherapy.2

What kind of clinical trial is Preserve 3?

The Preserve 3 trial is a phase 2, randomized, open-label study. Phase 2 studies look at whether this new treatment will work. Studies are randomized when the participants are split into study groups by chance. Open-label studies are the opposite of blinded studies. Both the participants and the researchers are aware of what drugs each group gets.1

mUC treatment effectiveness

The main goal of this clinical trial is to see if this combination of drugs is effective. Researchers hope that the addition of Cosela could improve survival rates for people with mUC.1

They also are looking to see how well Cosela prevents bone marrow damage. Finally, they would like to see how participants are affected by the combination of drugs.1

What is next?

Researchers are performing this clinical trial to see how effective this treatment is. If it is successful, they will move on to a phase 3 trial. That trial will focus on what dose of Cosela is will improve survival without increasing side effects. If that is successful, the U.S. Food and Drug Administration (FDA) may be able to approve the use of Cosela for people with mUC.1

Impact on mUC treatment

Researchers still need to explore how Cosela may impact people with mUC. This means the drug may not be available for quite some time. However, researchers are still looking for people with locally advanced or metastatic urothelial carcinoma to enroll in the clinical trial. If you are interested in participating in this trial, talk to your doctor about whether it might be right for you.

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