ImmunityBio的ANKTIVA获阿联酋NMIBC和转移性NSCLC营销授权

The UAE authorization further expands ANKTIVA’s global regulatory footprint to 34 countries. The BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) authorization is the first worldwide to span the full spectrum of BCG-unresponsive disease: carcinoma in situ (CIS) with or without papillary tumors, and papillary disease alone without CIS.

The Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) granted Marketing Authorization for two ANKTIVA presentations, the broadest approval to date for ANKTIVA including papillary disease and CIS in non-muscle invasive bladder cancer and non-small cell lung cancer in patients who failed checkpoint inhibitors and chemotherapy.

Each approval covers a distinct indication: ANKTIVA 0.4 mg/0.4 mL (solution for intravesical instillation) in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg/0.6 mL (solution for subcutaneous injection) in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC).

NMIBC evidence (QUILT-3.032): in the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61,80), with duration of complete response extending beyond 54 months; in the papillary-only cohort (N=80), 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a cystectomy free rate at 36-months of 83%.

In the NSCLC indication, ANKTIVA plus a checkpoint inhibitor is authorized for adult patients with metastatic disease that progressed on or after standard of care including checkpoint failure. NSCLC evidence (QUILT-3.055): in checkpoint-refractory advanced NSCLC (N=79), median overall survival was 14.6 months (95% CI: 12.0, 19.5), with subjects of mean on-treatment ALC ≥ 1,000 achieving of median OS of 16.2 months (95% CI: 13.8, 22.0).

CULVER CITY, Calif., July 29, 2026 — ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage biotechnology company, today announced that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA ® (nogapendekin alfa inbakicept) across two indications. The authorization covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC. With this action, the UAE becomes the fifth regulatory jurisdiction to authorize ANKTIVA, expanding its global footprint to 34 countries. The UAE has taken the lead in the broadest approval of ANKTIVA to date. The NMIBC authorization is the first anywhere in the world to span carcinoma in situ (CIS) and papillary disease, including patients with papillary-only tumors in the absence of CIS.

World’s First Approval Spanning the Full Spectrum of BCG-Unresponsive Disease in NMIBC

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and BCG-unresponsive NMIBC with papillary tumors. Eligible patients therefore include those with CIS alone, CIS accompanied by papillary tumors, and papillary disease alone without CIS.

BCG-unresponsive NMIBC carries a high risk of progression and, historically, radical cystectomy has been the standard option for patients who fail BCG. An approval that spans CIS and papillary disease addresses a defined unmet need across the disease spectrum by offering an alternative immunotherapy option.

“For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007 , we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy . This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.

Authorization in Checkpoint-Refractory Metastatic Non-Small Cell Lung Cancer

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alterations should have disease progression on approved therapy for those alterations, before receiving ANKTIVA in combination with immune checkpoint inhibitors. In this indication, ANKTIVA is administered as a fixed 1 mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy.

Checkpoint inhibitor resistance represents a defined unmet need in metastatic NSCLC, with limited options and poor survival after progression. By activating the natural killer and memory T cells that checkpoint inhibitors alone do not reach, ANKTIVA is designed to restore anti-tumor immunity in this setting.

Clinical Evidence Supporting the Approvals

NMIBC Indication: The NMIBC authorization is supported by QUILT-3.032, the multicenter registrational trial of ANKTIVA plus BCG in BCG-unresponsive NMIBC (ClinicalTrials.gov NCT03022825 ).

CIS with or without Papillary Disease (QUILT-3.032, Cohort A): In the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61, 80) as shown in table below.

Papillary Disease Alone (QUILT-3.032, Cohort B): In the papillary-only cohort (papillary disease without CIS; N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months as shown in the table below.

In the QUILT-3.032 program, most treatment-related adverse events were Grade 1 or 2; Grade 3 treatment-related adverse events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported.

NSCLC Indication: The NSCLC authorization is supported by QUILT-3.055 (ClinicalTrials.gov NCT03228667 ), a Phase 2 study of ANKTIVA in combination with a checkpoint inhibitor in patients with advanced NSCLC whose disease had progressed on prior checkpoint inhibitor therapy (N=79). Median overall survival was 14.6 months (95% CI: 12.0, 19.5). Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0). The table below summarizes these findings.

In QUILT-3.055, the most common NAI-related adverse drug reactions were injection site reaction (86%), chills (46%), fatigue (32%), pyrexia (28%), nausea (16%), injection site erythema and injection site pruritus (15% each), injection site pain (14%), influenza like illness (13%), decreased appetite (10%).

Regulatory Details

The EDE issued Marketing Authorization approval for both presentations with first registration in July 2026 and validity through July 2031. ANKTIVA 0.4 mg (solution for intravesical instillation), indicated for BCG-unresponsive