At-a-Glance
- ImmunityBio receives conditional marketing authorization from the European Commission for ANKTIVA® (nogapendekin alfa inbakicept) + BCG.
- First immunotherapy authorized in Europe for BCG-unresponsive NMIBC carcinoma in situ (CIS), with or without papillary tumors.
- Phase 2/3 QUILT-3.032 trial showed 71% complete response (CR) rate with median CR duration of 26.6 months.
- Approval expands ANKTIVA’s footprint to 33 countries across four regulatory jurisdictions.
Written By: Karthik Teja PharmD
Reviewed By: Pharmacally Editorial Team
ImmunityBio, a leader in immunotherapy, announced that the European Commission has granted conditional marketing authorization for ANKTIVA® (nogapendekin alfa inbakicept) combined with Bacillus Calmette-Guérin (BCG) to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. This marks the first authorized therapy in Europe for this high-risk patient group, addressing a critical gap where radical cystectomy was previously the main option.
Dr. Patrick Soon-Shiong, ImmunityBio’s Founder and Global Chief Scientific Officer, highlighted that over 80% of treated patients retain their bladder at three years, calling it a “meaningful advance” in immune response durability.
Clinical Evidence from QUILT-3.032 Trial
The approval stems from the phase 2/3 QUILT-3.032 trial (NCT03022825), a single-arm study of 100 BCG-unresponsive NMIBC CIS patients receiving intravesical ANKTIVA+BCG.
Key Efficacy Results
- Complete response (CR) rate: 71% (95% CI: 61-80%), with responses up to 54+ months ongoing.
- Median CR duration: 26.6 months (95% CI: 13.0-49.9).
- CR at 12/24 months: 66% and 42%.
- Cystectomy-free survival (responders): 96% (12 months), 90% (24 months), 84% (36 months).
- Disease-specific survival (all patients): 99% at 24/36 months.
Safety Profile
In 180 patients (Cohorts A/B):
- Mostly grade 1-2 events; 3% grade 3; no grade 4/5.
- Common reactions: dysuria, hematuria, pollakiuria, UTI, urgency, fatigue, chills, pain, pyrexia.
The CHMP’s positive opinion (December 11, 2025) weighed these benefits against single-arm data risks, favoring early access.
Expanding Global Reach
Approved just under two years after its initial U.S. FDA nod in April 2024, ANKTIVA now holds authorizations in 33 countries across four jurisdictions:
- United States: FDA approval for NMIBC CIS ± papillary tumors.
- United Kingdom: MHRA approval (July 2025) for the same indication.
- Kingdom of Saudi Arabia: SFDA accelerated approval (January 2026) for NMIBC CIS and metastatic non-small cell lung cancer (NSCLC), including the world’s first subcutaneous administration approval.
- European Union + EEA: Covers 27 EU states (Austria to Sweden), plus Iceland, Liechtenstein, and Norway.
This rapid global footprint underscores ANKTIVA’s strong clinical profile.
In Europe, unlike the U.S. with its single BCG strain shortage issues, six approved BCG strains ensure reliable supply for the combination regimen.
Richard Adcock, President and CEO of ImmunityBio, emphasized the company’s next steps, which include securing pricing and reimbursement agreements across EU member states and advancing its recombinant BCG candidate to address ongoing BCG shortages in the U.S. This authorization transforms care for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) by prioritizing bladder preservation and immune system activation.
About ANKTIVA
ANKTIVA, an IL-15 receptor agonist (400 µg intravesical suspension), fuses mutant IL-15 (N72D) to IL-15 receptor alpha Fc. It activates NK cells, CD4+/CD8+ T cells, combats immune escape, and boosts durable responses with superior pharmacokinetics over native IL-15.
ImmunityBio launched the Phase 2 ResQ215B trial (February 2026) evaluating chemotherapy- and lymphodepletion-free CAR-NK cell therapy with ANKTIVA and rituximab in indolent B-cell non-Hodgkin lymphoma, including Waldenström’s macroglobulinemia. The company is also advancing toward FDA resubmission for ANKTIVA + BCG in BCG-unresponsive papillary NMIBC following recent Type B meetings, supported by long-term QUILT-3.032 data.
This conditional approval requires ongoing QUILT-3.032 follow-up data submissions and annual renewal, per EU Regulation 726/2004. For full prescribing information, including dosing, contraindications, and warnings, refer to the official EMA Summary of Product Characteristics: Anktiva EPAR
Bladder cancer is the fifth most common cancer in the EU and seventh in men, with over 200,000 projected new cases in 2025. About 75% are NMIBC, confined to the bladder lining. For BCG-unresponsive CIS the most aggressive NMIBC subtype no prior EU treatments existed, forcing many toward cystectomy, which impairs quality of life.
ANKTIVA+BCG offers a bladder-preserving alternative.
Reference
ImmunityBio Receives Authorization from the European Commission for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ, Expanding Global Access to 33 Countries, 18 February 2026, https://immunitybio.com/immunitybio-receives-authorization-from-the-european-commission-for-anktiva-with-bcg-for-non-muscle-invasive-bladder-cancer-carcinoma-in-situ-expanding-global-access-to-33-countries/
QUILT-3.032: A Multicentre Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer, ClinicalTrials.gov ID NCT03022825, https://clinicaltrials.gov/study/NCT03022825
Chamie K et al, Quality of Life in the Phase 2/3 Trial of N-803 Plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin‒Unresponsive Nonmuscle-Invasive Bladder Cancer. Urol Pract. 2024 Mar;11(2):367-375. Epub 2024 Jan 16. PMID: 38226931. https://doi.org/10.1097/upj.0000000000000517