Bladder cancer, overall, is the sixth most common type of cancer. Seventy percent of new bladder cancer cases are classified as non-muscle invasive bladder cancer (NMIBC), meaning the cancer cells are in the inner lining of the bladder and have not invaded the muscle wall.
Ohio patients with NMIBC may be eligible to participate in a nationwide study (QUILT-2.005) examining the effectiveness of Anktiva, a new immunotherapy drug approved by the Food and Drug Administration intended to enhance the body’s immune response to fight cancer.
Understanding NMIBC
Central Ohio Urology Group
Dr. Benjamin Martin
While NMIBC is not directly life-threatening, it has an estimated recurrence rate of 50-70 percent with up to 30 percent of cases invading the bladder muscle or even other parts of the body.
“(Bladder cancer) often can be just a minor thing on the surface, so if you treat it early, it’s fine. But you need to be checked because the cancer has a bad habit of coming back.” says Dr. Benjamin Martin, a urologist at the Central Ohio Urology Group (COUG) in Gahanna. “We’re not as worried about the cancer coming back, but we are worried about the cancer coming back worse.”
For more invasive bladder cancer, or aggressive NMIBC that does not respond to traditional treatment, a radical cystectomy (removal of the entire bladder) may be recommended.
“(A cystectomy) has been our fallback. That’s a big step, obviously, and people don’t generally want to do that,” Martin says.
Although Martin says people who’ve had a cystectomy can still live a normal life, he emphasizes that the invasiveness of a cystectomy creates the need for alternative treatments that spare the bladder, especially when traditional treatment fails.
Traditional treatment
Treatment of NMIBC typically involves a minimally invasive procedure to remove the tumor. Patients may also receive intravesical therapy, which involves medicine administered directly into the bladder via a catheter.
A standard medication that is typically used is Bacillus Calmette-Guérin (BCG), a weakened form of tuberculosis that triggers the immune system to attack the abnormal cells. This immunotherapy method is typically administered once a week for six weeks.
Unfortunately, BCG fails in 40 percent of patients, and a shortage since 2019 has prompted physicians to make difficult decisions.
“We’ve had some stretches where we’ve had to tell patients, ‘Hey, we’ve only got 10 doses and we’ve got three patients. We have to treat the worst patient first.’ If you’re not bad enough, we have to wait,” Martin says.
Although the FDA authorized recombinant BCG in February of 2025 to address the shortage, it doesn’t fix BCG’s efficacy issues. However, in light of the shortage, a handful of alternative therapies have emerged for bladder cancer treatment.
Offering hope
ImmunityBio
The FDA approved Anktiva for treatment in April 2024.
Among these new therapies is Anktiva, an immunotherapy developed by ImmunityBio. The FDA approved Anktiva for the treatment of BCG-unresponsive NMIBC in April of 2024.
Early studies suggest Anktiva paired with BCG may help reduce recurrence and improve survival rates, compared to BCG alone.
Martin explains that BCG causes a general immune response, but Anktiva can help modify that immune response to be more specific toward fighting cancer.
“Anktiva has been tested in people who have failed BCG, and it’s been shown that it can, not 100 percent, but it can rescue those patients and provide a durable, cancer-free response. It can fight the cancer for an extended period of time,” Martin says.
Opportunity for patients
A current, nationwide clinical study sponsored by ImmunityBio is looking to compare the effectiveness of Anktiva paired with BCG to BCG alone in NMIBC patients who have not had prior BCG treatment.
The study includes three locations in Ohio, one of which is the Central Ohio Urology Group in Gahanna.
As the principal investigator at COUG, Martin acknowledges that research isn’t for everyone, but he is optimistic about the benefits of participation, especially since participants are guaranteed treatment.
“If you enter the research trial, it’s all covered by research. You don’t have to pay for it with insurance,” Martin says. “(Patients) get the treatment they would’ve gotten anyway, or they get the treatment with the new Anktiva drug, so I think it is kind of a win-win for everybody.”
Although some patients may not qualify for the Anktiva study, COUG participates in other clinical studies. Martin emphasizes that participation is voluntary and that the medicine has been tested.
“These medications have been thoroughly evaluated, and we’re just trying to confirm what we have found from earlier studies.” Martin says. “It’s not right for everybody, but I think, in the right situation, we like to be able to offer these research trials and give patients a choice when sometimes they have no choice.”
To learn more about the local clinical studies for Anktiva, visit www.centralohiourology.com.
Amanda Stevens is an editorial assistant at CityScene Media Group. Feedback welcome at feedback@cityscenemediagroup.com.
