Key Highlights
- ImmunityBio shares rise following UAE’s comprehensive ANKTIVA authorization
- Regulatory clearance encompasses full spectrum of BCG-unresponsive bladder cancer in adults
- UAE authorization includes metastatic lung cancer patients following prior treatment failure
- Clinical trial demonstrates 71% complete response rate in bladder cancer patients treated with ANKTIVA
- Therapy now reaches 34 countries following ImmunityBio’s expanded international regulatory footprint
Shares of ImmunityBio (IBRX) climbed 5.86% during pre-market hours to reach $7.23, recovering from the previous session’s 2.01% decline to $6.83. The upward movement came after the United Arab Emirates granted authorization for ANKTIVA in treating bladder and lung cancers where therapeutic alternatives remain scarce. This regulatory milestone represents the company’s most comprehensive approval to date and significantly extends the treatment’s global commercial footprint.
Comprehensive UAE Authorization Covers Dual Cancer Applications
The Emirates Drug Establishment has granted approval for ANKTIVA combined with BCG in adult patients diagnosed with BCG-unresponsive non-muscle invasive bladder cancer. The authorization encompasses carcinoma in situ, mixed tumor presentations, and papillary-only disease excluding carcinoma in situ. This represents the first time a single regulatory decision has covered the complete BCG-unresponsive NMIBC disease spectrum.
Additionally, the regulatory body approved ANKTIVA in combination with immune checkpoint inhibitors for treating metastatic non-small cell lung cancer. The indication targets patients whose disease has advanced following standard checkpoint inhibitor therapy or chemotherapy regimens. For patients harboring actionable genetic mutations, progression following approved targeted therapies is required before ANKTIVA combination treatment eligibility.
With this authorization, the UAE joins four other regulatory jurisdictions that have cleared ANKTIVA for use. According to ImmunityBio, the therapy has now achieved regulatory accessibility spanning 34 nations through various international approvals. This expanded regulatory framework enhances the company’s market position in two challenging oncology segments facing substantial unmet medical requirements.
Clinical Evidence Validates Extensive NMIBC Application
The bladder cancer authorization stems from findings generated by the multicenter QUILT-3.032 registrational trial. Among patients with carcinoma in situ, the ANKTIVA and BCG combination produced a 71% complete response rate. Responding patients demonstrated a median response duration of 26.6 months throughout extended trial observation.
Complete response persistence was observed in 66% of responders at the 12-month assessment point. By 24 months, 42% continued demonstrating complete responses following combination therapy. These outcomes provided evidence supporting treatment application across patients presenting with carcinoma in situ and associated papillary tumor types.
Within the papillary-only patient cohort, disease-free survival reached 58.2% at the 12-month milestone. This patient population achieved a median disease-free survival of 25.3 months. Notably, 83.1% of trial participants retained their bladders at 36 months, maintaining a critical organ-preservation treatment pathway.
Lung Cancer Evidence Broadens ANKTIVA’s Commercial Potential
The lung cancer indication draws upon data from the Phase 2 QUILT-3.055 clinical investigation. This trial included 79 patients experiencing disease progression following prior checkpoint inhibitor exposure. The overall study population achieved a median overall survival of 14.6 months from treatment initiation.
Among patients presenting with elevated lymphocyte counts, median overall survival extended to 16.2 months. This subgroup comprised 77% of study participants. Their survival outcomes surpassed the 11.8-month median reported in patients with reduced lymphocyte levels.
Common adverse events included injection site reactions, chills, fatigue, fever, and nausea. The bladder cancer trial predominantly documented Grade 1 or Grade 2 treatment-related adverse events. ImmunityBio strengthens its regulatory foundation as it continues advancing ANKTIVA’s international expansion strategy across new geographic markets.
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