Rebounds as UAE Approves ANKTIVA for Bladder and Lung Cancer

TLDR

• ImmunityBio stock rebounds as UAE grants ANKTIVA its broadest approval to date
• UAE clears ANKTIVA for bladder cancer across the full disease spectrum in adults
• ANKTIVA gains UAE approval for metastatic lung cancer after therapy failure
• Bladder cancer trial reports a 71% complete response rate with ANKTIVA in patients
• ImmunityBio expands ANKTIVA’s global regulatory reach across 34 countries worldwide

ImmunityBio (IBRX) shares gained 5.86% in pre-market trading to $7.23 after closing 2.01% lower at $6.83. The rebound followed UAE authorization for ANKTIVA across bladder and lung cancer indications with limited treatment options. The decision gives ImmunityBio its broadest regulatory approval while expanding the therapy’s international commercial reach.

UAE Expands ANKTIVA Approval Across Two Cancer Indications

The Emirates Drug Establishment approved ANKTIVA with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer. The authorization includes carcinoma in situ, mixed tumors, and papillary-only disease without carcinoma in situ. This marks the first approval covering the full BCG-unresponsive NMIBC spectrum under one regulatory decision.

The regulator also approved ANKTIVA with immune checkpoint inhibitors for metastatic non-small cell lung cancer. Eligible patients must show disease progression after standard checkpoint therapy or chemotherapy combinations. Patients with actionable mutations must first progress after approved targeted treatments before receiving the ANKTIVA combination.

The UAE now becomes the fifth regulatory jurisdiction to authorize ANKTIVA. ImmunityBio said the therapy now has regulatory reach across 34 countries through international approvals. The broader decision strengthens the company’s commercial positioning in two difficult cancer markets with major unmet needs.

Bladder Cancer Data Support Broad NMIBC Use

The bladder cancer approval relies on results from the multicenter QUILT-3.032 registrational study. In the carcinoma in situ cohort, ANKTIVA and BCG achieved a 71% complete response rate. The median response duration reached 26.6 months among responding patients during the extended study follow-up.

At 12 months, 66% of responders maintained a complete response. At 24 months, 42% still showed a complete response after receiving the treatment combination. These results supported treatment across patients with carcinoma in situ and related papillary tumors.

The papillary-only cohort reported a 58.2% disease-free survival rate at 12 months. Median disease-free survival reached 25.3 months in that patient group. Meanwhile, 83.1% of patients avoided bladder removal at 36 months, preserving an important organ-saving option.

Lung Cancer Results Extend ANKTIVA’s Market Scope

The lung cancer authorization draws support from the Phase 2 QUILT-3.055 study. The trial enrolled 79 patients whose disease progressed after previous checkpoint inhibitor treatment. Median overall survival reached 14.6 months across the full study population after treatment began.

Patients with higher lymphocyte counts recorded median overall survival of 16.2 months. That group represented 77% of enrolled patients in the study. Their survival results exceeded the 11.8 months reported among patients with lower lymphocyte counts.

The therapy produced frequent injection site reactions, chills, fatigue, fever, and nausea. The bladder cancer study reported mostly Grade 1 or Grade 2 treatment-related events. ImmunityBio now gains a wider regulatory base as it advances ANKTIVA’s international rollout across additional markets.