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Immunotherapy is one of the newest types of bladder cancer treatments. This type of treatment has become an important option for people with advanced bladder cancer or bladder cancer that has spread to other parts of the body (metastatic bladder cancer). These advanced stages of bladder cancer often have a poor outlook, or prognosis. Surgery is usually not an option in these cases, which leaves fewer treatment alternatives.
Read on to learn how immunotherapy works and how effective it is for treating advanced and metastatic stages of bladder cancer.
Immunotherapy is a type of cancer treatment that uses your immune system to fight cancer. Some types of immunotherapy boost your immune response to help your immune system find and destroy cancer cells. Others use laboratory-made immune proteins, such as antibodies, to make your immune system work better. Several types of immunotherapy have helped improve the prognosis for people with advanced and metastatic bladder cancer. It can also help with symptoms and improve quality of life.
Intravesical immunotherapy is a bladder cancer treatment. It’s often used for early-stage bladder cancers, such as non-muscle-invasive bladder cancer (NMIBC).
During this treatment, a liquid medicine is placed directly into the bladder using a thin tube called a catheter that goes through the urethra — the opening where urine leaves the body. Because intravesical immunotherapy only targets the bladder’s inner lining, it doesn’t treat cancer that has spread deeper into the bladder wall or to other parts of the body.
The U.S. Food and Drug Administration (FDA) has approved three immunotherapies for intravesical therapy:
Bacillus Calmette-Guérin (Tice BCG) was the first immunotherapy used to treat bladder cancer and has been around for almost 60 years. It’s the most common intravesical immunotherapy for early-stage bladder cancer.
BCG is made from a type of bacteria related to the one that causes tuberculosis, but it doesn’t cause the disease. When placed into the bladder, the treatment helps activate your immune system to recognize and attack cancer cells.
A systematic review — a detailed study of multiple studies on the same topic — found that 54 percent to 89 percent of people with NMIBC stayed cancer-free for at least two years after getting BCG treatment. But newer research from 2024 showed that bladder cancer returns in about half of people after BCG treatment.
Nadofaragene firadenovec (Adstiladrin) uses a virus to carry a gene that makes a protein called interferon alfa-2b. Interferon alfa-2b is an immune system protein that helps the body’s immune system attack cancer cells. It’s usually used in people who have a high risk of NMIBC returning when BCG doesn’t help.
In clinical trials, about half of the people treated with nadofaragene firadenovec avoided a cystectomy (bladder removal surgery) for at least five years.
Nogapendekin alfa inbakicept (Anktiva) is a medicine that helps your immune system find and attack cancer cells. It works by activating a part of the immune system called the interleukin-15 receptor. Doctors use it with BCG when BCG treatment alone isn’t working well enough.
In clinical trials, 58 percent of people had no signs of bladder cancer one year after treatment. After two years, 40 percent of people still had no signs of bladder cancer.
Immune checkpoint inhibitors (ICIs) are another type of immunotherapy. They work by blocking proteins called checkpoint proteins that some cancer cells use to hide from the immune system. Once these checkpoint proteins are inhibited (blocked), immune cells can recognize and destroy cancer cells.
As of April 2025, there were four FDA-approved ICIs for bladder cancer. More ICIs are being tested in clinical trials, and new ones are expected to be approved for the treatment of bladder cancer in the future.
Pembrolizumab (Keytruda) targets a checkpoint protein called PD-1 found on immune cells. Doctors use pembrolizumab by itself to treat different cases of bladder cancer, including:
Several clinical trials with pembrolizumab have shown the drug’s potential benefit. In one study of people with advanced or metastatic bladder cancer who didn’t respond to chemotherapy, pembrolizumab extended overall survival by about three months, increasing median survival from 7.4 months with chemotherapy to 10.3 months.
In a follow-up study five years later, 14.9 percent of people treated with pembrolizumab were still alive compared to the 8.7 percent treated with chemotherapy.
In people with NMIBC, 46 percent of those treated with pembrolizumab had no signs of bladder cancer for at least 12 months.
Researchers are studying how pembrolizumab can help when used earlier in treatment. In a 2024 clinical trial, people with muscle-invasive bladder cancer (MIBC) took pembrolizumab for a year after having a cystectomy. On average, those who took pembrolizumab stayed cancer-free for 29.6 months. In comparison, those who didn’t receive the drug stayed cancer-free for 14.2 months. This means that half of the people who received pembrolizumab had no signs of cancer for at least 29.6 months after treatment — almost 2.5 years.
Avelumab (Bavencio) is a type of immunotherapy that targets a checkpoint protein called PD-L1, which some cancer cells use to hide from the immune system. Doctors may use avelumab in people with advanced or metastatic bladder cancer that hasn’t improved after first-line chemotherapy and cannot be treated with surgery.
In clinical trials, researchers tested how well avelumab works by looking at overall survival. Overall survival is the length of time people live after the start of treatment. The median overall survival for people treated with avelumab was 21.4 months. In other words, half of the people treated with avelumab were alive at least 21.4 months after starting treatment. People who didn’t get the drug had a median overall survival of 14.3 months. That’s a difference of more than 7 months.
Nivolumab (Opdivo) also targets protein PD-1. This drug can be used to treat bladder cancer in a few different ways:
When used after surgery, nivolumab almost doubled the amount of time people lived without their cancer worsening or returning. On average, people stayed cancer-free for 20.8 months with nivolumab, compared to 10.8 months with a placebo (a treatment with no active drug). When nivolumab was given along with cisplatin and gemcitabine, people lived about three months longer than those who received chemo alone — 21.7 months versus 18.9 months.
Durvalumab (Imfinzi) is another immunotherapy drug that targets the protein PD-L1. PD-L1 allows T cells (immune cells) to target and destroy bladder cancer cells. It’s approved by the FDA to treat urothelial carcinoma, the most common form of bladder cancer, when:
In clinical trials, about 26 percent of people whose tumors had high levels of the PD-L1 protein responded to durvalumab. In comparison, only about 4 percent of people whose tumors had low PD-L1 levels had a response. These trials also showed that durvalumab significantly improved overall survival rates in people with urothelial carcinoma.
The FDA also approved a diagnostic test that checks the levels of PD-L1 on bladder cancer tumors. This test can help doctors determine whether durvalumab or other ICIs will be effective treatment options.
Antibody-drug conjugates (ADCs) are another type of cancer treatment. These drugs combine a monoclonal antibody — an immune protein made in a lab — with a chemo drug. The monoclonal antibody is designed to target cancer cells and deliver the chemo drug directly to them.
Enfortumab vedotin (Padcev) is an FDA-approved ADC used to treat advanced bladder cancer. It can be used on its own to treat people with advanced bladder cancer who have not responded to an ICI. Enfortumab vedotin is also an option for people who can’t take cisplatin but have tried at least one other type of drug treatment. In clinical trials, 44 percent of participants treated with enfortumab vedotin had tumors that shrank or stopped growing.
Pembrolizumab can be combined with enfortumab vedotin as a first treatment for people with advanced bladder cancer. This combination is especially helpful for people who can’t tolerate traditional chemotherapy. In clinical trials, 68 percent of people had tumors shrink during treatment with this combination. Additionally, about 12 percent had all signs of cancer disappear.
Immunotherapy is changing bladder cancer care, especially for advanced and metastatic cases that are difficult to manage with traditional therapies. These treatments offer new hope by using the body’s own immune system to target cancer cells.
Clinical trials continue to show the major benefits of these treatments, like longer survival and long-lasting results. However, these medications can also cause side effects. It is important to talk with your doctor about possible side effects you may experience during and after treatment.
If you or a loved one is dealing with bladder cancer, ask your doctor whether immunotherapy might be right for you. With more FDA-approved drugs and new combination therapies becoming available, a personalized treatment plan could make a real difference.
MyBladderCancerTeam is the social network for people with bladder cancer and their loved ones. On MyBladderCancerTeam, members come together to ask questions, give advice, and share their stories with others who understand life with bladder cancer.
Have you taken immunotherapy for bladder cancer? How did it work for you? Share your experience in the comments below, or start a conversation by posting on your Activities page.
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A MyBladderCancerTeam Member
This was a great article. I was particularly interested in options when become BCG unresponsive. Click through the on the actual therapy for more detail was very helpful for when the therapy could be… read more
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