ImmunityBio Shares Rise After UAE Approves Cancer Drug ANKTIVA for Two Indications

Shares of ImmunityBio (NASDAQ: IBRX) rose 7.5% in Thursday trading after the company announced it had received marketing authorization for its drug ANKTIVA in the United Arab Emirates (UAE) for two separate cancer treatments.

Dual Indications Approved

The Emirates Drug Establishment, the UAE's regulatory body, approved ANKTIVA for two distinct indications. The first is for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), where ANKTIVA is used in combination with the Bacillus Calmette-Guérin (BCG) vaccine.

The second approved indication is for adult patients with metastatic non-small cell lung cancer (NSCLC) that has progressed after standard treatments, including checkpoint inhibitors. For this use, ANKTIVA is authorized in combination with immune checkpoint inhibitors.

Supporting Clinical Data

The approvals were based on data from two key clinical trials. The NMIBC authorization stems from the QUILT-3.032 trial, which demonstrated significant efficacy:

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• A 71% complete response rate in patients with carcinoma in situ (CIS), with the duration of response extending beyond 54 months.
• A 58.2% disease-free survival rate at 12 months for patients with papillary-only disease.

The NSCLC approval was supported by the QUILT-3.055 trial. In a cohort of 79 patients with advanced, checkpoint-refractory NSCLC, the combination therapy showed a median overall survival of 14.6 months.

Market Impact and Global Expansion

This authorization from the UAE marks the fifth regulatory jurisdiction to approve ANKTIVA, expanding the drug's global regulatory footprint to 34 countries. The approval is particularly notable for NMIBC, as it is the first worldwide to cover the full spectrum of BCG-unresponsive disease.

For investors, the expanding market access for ANKTIVA represents a key step in the company's commercialization strategy. The drug offers a new option for NMIBC patients who fail BCG therapy and whose standard alternative is often radical cystectomy, or the complete removal of the bladder.