NCCN Integrates ImmunityBio’s Anktiva in Bladder Cancer Guidelines
The National Comprehensive Cancer Network has broadened its bladder cancer guidance to include ImmunityBio’s Anktiva combined with BCG. The change covers patients with BCG-unresponsive papillary-only non-muscle invasive bladder cancer. NCCN issued the update in mid-March 2026, with Version 1.2026 effective March 16, 2026.
What the guideline change means
The recommendation assigns Anktiva plus BCG a Category 2A designation. That reflects uniform expert consensus despite limited phase 3 data. Clinicians and payers use NCCN guidance to shape treatment and coverage decisions.
The update expands prior guidance. Anktiva had been recommended only for carcinoma in situ with or without papillary disease after its April 2024 FDA approval. The new language explicitly covers high-grade papillary-only disease without concurrent CIS.
Evidence behind the decision
QUILT-3.032 trial results
The change rests largely on data from cohort B of the phase 2/3 QUILT-3.032 program. Eighty patients with high-grade, papillary-only BCG-unresponsive NMIBC received intravesical Anktiva 400 μg plus BCG 50 mg. Treatments were delivered once weekly for six weeks.
- 24-month disease-free survival was reported at 52.1%.
- 36-month disease-free survival was reported at 38.2%.
- Thirty-six-month disease-specific survival was 96.0%.
- Reported cystectomy-free survival at three years exceeded 80%.
- Overall analyses combined cohorts A and B (n = 180) for safety reporting.
Safety profile
Adverse events were mostly low-grade. Sixty-one percent of treatment-related events were Grade 1–2. Grade 3 events occurred in about 3% of patients. No Grade 4 or 5 treatment-related events were reported.
Investigators reported no immune-related Grade ≥3 toxicities and no treatment-related deaths. The regimen is given intravesically to concentrate effect in the bladder.
Mechanism and clinical context
Anktiva is an IL-15 superagonist designed to amplify BCG-driven immunity. The molecule targets IL-15 receptors on natural killer and CD8+ T cells. The combination aims to boost local immune attack and establish longer anti-tumor memory.
ImmunityBio positions Anktiva within a broader Cancer BioShield strategy. The company is also advancing a pivotal trial in BCG-naïve NMIBC patients.
Regulatory and market outlook
ImmunityBio resubmitted a supplemental Biologics License Application in March 2026. The filing seeks FDA label expansion to include papillary-only BCG-unresponsive disease. Until the FDA acts, this use remains off-label despite NCCN inclusion.
Company leaders framed the guideline change as a milestone. They noted the potential to expand bladder-sparing options and to align regulatory labeling with expert guidance.
Implications for clinicians and patients
The guideline revision offers an immunotherapy-based, bladder-preserving option for patients who previously faced cystectomy. Urologists and medical oncologists may now consider Anktiva plus BCG for this subgroup. Payers often reference NCCN guidance when setting coverage policies, which could affect access.
Filmogaz.com will continue to monitor regulatory decisions and emerging data on Anktiva. The report underscores a broader shift toward immune-based treatments in earlier-stage cancers.
