NCCN Guidelines Expand Options for Certain Bladder Cancer Patients

Patients with a specific type of bladder cancer may now have a new treatment option reflected in national guidelines. According to a recent news release, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology have been updated to include Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with papillary-only disease.

“These updated NCCN guideline recommendations in bladder cancer represent an important milestone for patients with BCG-unresponsive NMIBC papillary-only disease who have exhausted standard BCG therapy,” Dr. Patrick Soon-Shiong, founder, executive chairman and global chief scientific and medical officer of ImmunityBio, said in the news release.

This update is meaningful for patients whose cancer has not responded to standard BCG therapy and who have papillary tumors without carcinoma in situ (CIS). Historically, these patients have faced limited treatment options, often leading to more aggressive approaches such as bladder removal. The inclusion of Anktiva plus BCG in NCCN guidelines signals growing recognition of this combination as a potential bladder-preserving strategy.

What the guideline update means for patients

The addition of Anktiva plus BCG to NCCN guidelines highlights its role as a treatment option for a subset of patients with NMIBC whose disease no longer responds to BCG alone. This group, particularly those with papillary-only disease, represents a significant portion of BCG-unresponsive cases.

For many patients, the standard next step after BCG failure has been radical cystectomy, a surgery to remove the bladder. Although effective, this procedure can significantly affect quality of life. The guideline update suggests that Anktiva plus BCG may offer an alternative approach that allows some patients to delay or avoid surgery.

Clinical findings supporting this approach have shown encouraging durability of response and bladder preservation outcomes. Long-term data indicate that this immunotherapy-based combination may help sustain disease control in a population with otherwise limited options.

Understanding NMIBC and current treatment challenges

Non–muscle invasive bladder cancer is an early-stage form of bladder cancer that has not spread into the muscle layer of the bladder wall. It is commonly treated with intravesical therapy, most often BCG, which stimulates the immune system to attack cancer cells.

Although BCG has been a standard of care for decades, some patients experience recurrence or progression despite treatment. This is known as BCG-unresponsive disease, a challenging clinical scenario with fewer effective options.

Papillary-only NMIBC differs from CIS in that it tends to form visible tumor growths rather than flat lesions. Despite being considered less aggressive in some cases, papillary-only disease still poses a significant risk when it does not respond to BCG. Chemotherapy has traditionally been used in this setting, although outcomes can be variable.

How Anktiva plus BCG works

Anktiva is an immunotherapy designed to activate natural killer (NK) cells and T cells, enhancing the body’s immune response against cancer. When combined with BCG, the therapy aims to amplify immune system activity within the bladder.

This combination builds on the established mechanism of BCG by adding a cytokine-based immune stimulant. The goal is to improve both the depth and durability of response compared with BCG alone.

The regimen has already been approved for patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The NCCN update now reflects its potential use in papillary-only disease, expanding its relevance to a broader patient population.

Study methods and patient population

The data supporting Anktiva plus BCG come from clinical trials evaluating patients with BCG-unresponsive NMIBC, including those with papillary-only disease. These studies assessed outcomes such as complete response rates, duration of response, and bladder preservation.

Patients enrolled in these trials had disease that persisted or recurred despite prior BCG therapy. This population is considered high risk due to the likelihood of progression and limited treatment alternatives.

In addition, ongoing and completed trials, such as the QUILT program, have explored the effectiveness of Anktiva in combination with BCG across different NMIBC settings, including both BCG-naïve and BCG-unresponsive populations.

Additional information and future directions

Beyond the guideline update, emerging data continue to support the potential of Anktiva plus BCG in bladder cancer care. Studies have demonstrated high rates of bladder cancer–specific survival and prolonged time before cystectomy is needed, suggesting durable disease control.

Importantly, regulatory discussions are ongoing to expand the approved use of this combination therapy specifically for papillary-only NMIBC. Recent submissions to the FDA include updated long-term efficacy and safety data, reflecting continued efforts to bring this option to more patients.

References

1. “ImmunityBio Announces NCCN® Clinical Practice Guidelines in Oncology Have Been Updated to Include ANKTIVA® Plus BCG for Patients With BCG-Unresponsive NMIBC With Papillary-Only Disease,” by ImmunityBio, Inc. News release; March 17, 2026.

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