ImmunityBio's Anktiva Gains NCCN Guideline Inclusion for Bladder Cancer

The National Comprehensive Cancer Network has updated its 2026 Clinical Practice Guidelines in Oncology for bladder cancer to include ImmunityBio's Anktiva plus Bacillus Calmette-Guérin as a Category 2A recommendation for patients with BCG-unresponsive papillary-only non-muscle invasive bladder cancer. This landmark guideline inclusion expands the use of the IL-15 superagonist immunotherapy beyond its current focus on carcinoma in situ, marking a significant milestone for patients who have exhausted standard BCG therapy.

The new update adds papillary-only high-grade NMIBC to the eligible patient population, meaning patients whose bladder tumors are papillary lesions without concurrent CIS can now be considered for the Anktiva plus BCG regimen. The recommendation is classified as Category 2A, indicating uniform consensus by NCCN experts despite reliance on phase 2/3 trial data rather than phase 3 alone. Previously, NCCN guidelines recommended Anktiva + BCG only for BCG-unresponsive NMIBC with CIS ± papillary tumors, aligning with Anktiva's initial FDA approval in April 2024 for CIS with or without papillary disease.

The guideline update is underpinned by compelling clinical evidence from ImmunityBio's bladder cancer development program, particularly cohort B of the phase 2/3 QUILT-3.032 trial. In this study, 80 patients with high-grade papillary-only BCG-unresponsive NMIBC received Anktiva 400 μg plus BCG 50 mg intravesically once weekly for 6 weeks, with 2% of patients remaining disease-free at 12 months, meeting the trial's primary efficacy goal.

Separately, ImmunityBio announced that the Independent Data Monitoring Committee confirmed the statistical power of its pivotal randomized trial for Anktiva. The IDMC's review indicated that no additional enrollment is needed beyond the current 366 participants, confirming that the study is adequately powered to detect a clinically meaningful difference in complete response rates. The trial, known as QUILT-2.005, is evaluating Anktiva in combination with BCG for patients with non-muscle invasive bladder cancer with carcinoma in situ with or without papillary disease.

The company plans to submit a supplemental Biologics License Application based on the final data analysis in 2026. ImmunityBio has also submitted its response to the U.S. FDA's request for additional data related to BCG-unresponsive papillary-only NMIBC and awaits the Agency's review.

In Europe, ImmunityBio has established a partnership with Accord Healthcare to provide access to ANKTIVA in combination with BCG for eligible patients in the European Union with BCG-unresponsive NMIBC CIS, with or without papillary disease. The company also announced the establishment of an Irish subsidiary in Dublin to support its distribution and commercialization strategy throughout Europe. ANKTIVA in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS is now authorized across four major regulatory jurisdictions, encompassing 33 countries, including the United States, United Kingdom, Kingdom of Saudi Arabia, and the European Union.

The company's founder and executive chairman stated that the updated NCCN guideline recommendations represent an important milestone for patients with BCG-unresponsive NMIBC papillary-only disease who have exhausted standard BCG therapy. He noted that the addition of Anktiva plus BCG for papillary-only disease in the NCCN guidelines reflects the growing body of clinical data evaluating Anktiva in this patient population.