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How Johnson & Johnson is advancing new options for bladder cancer treatment

Every year, roughly 80,000 Americans receive a bladder cancer diagnosis. Many endure difficult and burdensome treatments in an attempt to fight the disease. But new innovations just might change that.

A headshot of bladder cancer patient Sumeet Bhanvadia

Sumeet Bhanvadia, M.D., Senior Director, Janssen

As a clinician who’s worked with thousands of patients, urologic oncologist Sumeet Bhanvadia, M.D., Senior Director, Janssen Pharmaceutical Companies of Johnson & Johnson, has seen firsthand how difficult and burdensome a bladder cancer diagnosis can be.

Bladder cancer patients tend to be older—in the U.S., the median age of diagnosis is 72—and already balancing an array of other age-related health problems.

Bladder cancer tumors are broadly categorized into three groups: nonmuscle invasive bladder cancer, muscle-invasive bladder cancer and metastatic bladder cancer. These categories determine the treatment needed. About three quarters of patients have tumors that are contained in the superficial layers lining the bladder (nonmuscle invasive), and these can be managed by a combination of IV medications, surgeries to shave off the tumor and drugs used inside the bladder to treat the cancer.

For those with muscle-invasive disease, treatment involves chemotherapy followed by surgical removal of the bladder. The chemotherapy is intensive and often not an option for patients because of other medical problems. The surgery can also be complex and therefore risky for elderly patients.

Removing the bladder also means that surgeons must create another way for urine to exit the body, which for the vast majority of patients is in the form of a permanent urinary stoma outside the body.

“While there are options to create a urinary diversion that is internal and is an excellent choice for some patients, the vast majority of patients will end up with a stoma,” says Dr. Bhanvadia. “In either case, this is a major disruption to one’s life and can seriously impact physical and psychological health. Many times, the patient’s loved ones will also go through a lot to provide care and support around this.”

A global team of physician-scientists at Janssen—including Dr. Bhanvadia and Chris Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Janssen Pharmaceutical Companies of Johnson & Johnson—is working on a number of studies to evaluate new therapies and drug delivery approaches to help address the ongoing unmet need patients with bladder cancer continue to face.

“Our ambition at Janssen is to change the treatment paradigm in bladder cancer and to bring new innovation to these patients who continue to experience a high unmet need,” says Dr. Bhanvadia.

We spoke with Dr. Bhanvadia to learn more about the urgent need for new options in the treatment of this challenging disease.

Q:

In the U.S., about 800,000 people are living with bladder cancer. Who is most likely to be affected by this disease, and what causes it?

A:

This is a cancer that affects mainly elderly people, and there’s a male predominance by about three to one. In addition to age, smoking is another big risk factor: For patients who are or have been smokers, there is evidence that smoking cessation can decrease the risk of developing the disease after a certain number of years. Even after a bladder cancer diagnosis, quitting can improve cancer outcomes.

A significant proportion of patients, particularly those who are 80 and older, receive no definitive therapy for their bladder cancer at all.

Currently there are no population-wide screenings for bladder cancer—although in high-risk groups, a lot of research is underway to explore whether targeted screening should be done for people at high risk, similar to what is being done for lung cancer.
In terms of detection, blood in the urine, which is called hematuria, tends to be the first warning sign of bladder cancer and warrants a prompt visit to the doctor. In women, hematuria is often attributed to a urinary tract infection and can lead to delays in the diagnosis of bladder cancer.

Q:

Once bladder cancer is diagnosed, how is it treated?

A:

We manage bladder cancers differently, depending on a patient’s diagnosis. We divide them into two broad buckets: muscle-invasive disease (MIBC) and nonmuscle invasive bladder cancer (NMIBC).

Seventy-five percent of new cases are nonmuscle invasive, and about 25% are muscle-invasive or metastatic, in which the cancer has spread beyond the bladder. Unfortunately, the muscle-invasive kind is lethal: Up to 50% of patients who have their bladders removed still have some kind of recurrence elsewhere in the body down the road.

The standard of care for bladder cancer is chemotherapy, concurrent chemotherapy and radiation or radical cystectomy—removal of the bladder. But a significant proportion of patients, particularly those who are 80 and older, receive no definitive therapy for their bladder cancer at all. Or they go straight to cystectomy.

Q:

Why do some patients not get chemotherapy, which can be very effective?

A:

Often, patients are older, so many aren’t good candidates for chemotherapy—which is an aggressive treatment—because they are frail or have poor kidney function or other comorbidities. Of course, cystectomy is a major abdominal surgery with risks for this group as well. About 60% of patients who undergo cystectomy will have a complication within the first 90 days of their operation.

Afterward, most patients will also have a urinary stoma, a bag that collects their urine outside of their body. It’s something they’ll need to manage for the rest of their lives.

We need therapies that are less burdensome for all patients with bladder cancer. Even for patients with localized bladder cancer who don’t have their bladders removed, the disease can become almost chronic: Recurrent tumors in the bladder are common, and there is the risk of developing a more aggressive tumor. For this reason patients need ongoing surveillance, often with in-office endoscopy of the bladder (called cystoscopy) and repeat treatments. That’s hard for the patient and the healthcare system. We need treatments with better durability.

Q:

Chemotherapy for bladder cancer can also be applied locally, straight to the bladder. But there’s a drawback to that method, right?

A:

Treating the bladder directly with chemotherapy agents is called intravesical therapy. It has been a standard of care therapy for bladder cancer for many years. A catheter is placed into the bladder and the medication is instilled through the catheter, where it is held for a couple of hours.

What excites me most is thinking outside the box and developing treatment paradigms that have the potential to change the way we treat bladder cancer.

Patients tend to tolerate this fairly well, but it has limited effectiveness in treating the cancer in the long-term. It’s possible that an hour or two is not long enough.

Q:

What approaches is Janssen working on to address unmet needs in the treatment of bladder cancer?

A:

Janssen has a number of clinical programs underway, which span the full spectrum of urothelial carcinoma, from nonmuscle invasive and muscle-invasive bladder cancer to metastatic disease. These include therapeutic options for the treatment of patients with certain gene mutations, as well as novel drug delivery technologies built to directly treat organ-confined tumors in the bladder.

Several years ago, a group of scientists from Boston started thinking about developing a device that could be used in the bladder. It’s a very unique organ, in that it’s a hollow place where things can float around. The idea was, Can you create something that could be placed in the bladder and then releases a medication in a slow, sustained way, over a longer period of time?

Q:

Are you excited about the potential for new options for bladder cancer patients?

A:

What excites me most is thinking outside the box and developing treatment paradigms that have the potential to change the way we treat bladder cancer and that may transform patient outcomes in the future.

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