Analysis demonstrates a lower cost per sustained responder and cystectomy avoided with ANKTIVA plus BCG compared to TAR-200 in Medicare population over three years

Company Website: https://immunitybio.com
CULVER CITY, Calif. -- (Business Wire)

ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced preliminary results from a new health economic analysis demonstrating that ANKTIVA^® (nogapendekin alfa inbakicept-pmln; NAI) plus Bacillus Calmette–Guérin (BCG) achieved a lower cost per sustained complete responder compared to TAR-200 in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ ± papillary disease (NMIBC CIS). The findings were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2026, May 17–20, 2026, at the Pennsylvania Convention Center in Philadelphia, by Ruchika Talwar, M.D., Medical Director and Assistant Professor Urologic Oncology at Vanderbilt Health.

The authors developed a cost-consequence model comparing ANKTIVA plus BCG, using data from the QUILT-3.032 study, with TAR-200, using data from the SunRISe-1 trial, and evaluated both clinical and economic outcomes in a U.S. Medicare population. A multi-state Markov model incorporating key NMIBC health states and clinical outcomes derived from a matched-adjusted indirect comparison (MAIC) of the two trials was used to assess costs associated with treatment acquisition, administration, healthcare resource utilization, radical cystectomy, and mortality.

Key findings include:

• Cost per cystectomy avoided: ANKTIVA plus BCG demonstrated savings of $109,622 at Year 1, $151,438 at Year 2, and $60,393 at Year 3 compared to TAR-200
• Cost per cystectomy-free month: Savings of $9,370 at Year 1, $6,144 at Year 2, and $1,520 at Year 3
• Cost per complete responder: Savings of $313,775 at Year 1 and $282,013 at Year 2

Cost reductions were primarily driven by lower drug acquisition and administration costs, based on complete response rates derived from an indirect treatment comparison—49.6% for ANKTIVA plus BCG versus 45.9% for TAR-200.

The authors concluded that ANKTIVA plus BCG offers direct cost savings across measurable clinical outcomes for patients with BCG-unresponsive NMIBC CIS compared to TAR-200 in a U.S. Medicare population, with savings persisting across all three years of the analysis.

“This health economic analysis reflects our dual mission of developing breakthrough immunotherapies that meaningfully extend lives, while ensuring these innovations are accessible within the broader healthcare landscape. By analyzing the rigorous economic efficiencies of our treatments, we are better positioned to ensure more patients can receive the most innovative and accessible cancer treatments available today,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These results solidify the potential value of ANKTIVA plus BCG in delivering durable responses while reducing costs to the Medicare healthcare system.”

“These findings reinforce the importance of aligning clinical innovation with both economic value and patient preferences,” said Ruchika Talwar, M.D., Medical Director and Assistant Professor Urologic Oncology at Vanderbilt Health. “In BCG-unresponsive NMIBC, treatment decisions are not solely about response rates; they are about durability, quality of life, and ensuring patients have access to therapies that are both effective and sustainable within the healthcare system.”

About BCG-Unresponsive NMIBC CIS

Non-muscle-invasive bladder cancer (NMIBC) represents approximately 75% of all bladder cancer diagnoses in the United States. Patients with carcinoma in situ (CIS) who become unresponsive to BCG therapy face a high risk of recurrence and progression and often have limited bladder-sparing treatment options available.

About ANKTIVA^® (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA^® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA^® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA^® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA^® with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA^® at Anktiva.com.

About Fight Bladder Cancer UK

Fight Bladder Cancer is the only patient-led bladder cancer charity in the United Kingdom. The charity is dedicated to supporting people affected by bladder cancer, raising awareness, and funding research to improve diagnosis and treatment. It provides support and mentorship for those impacted by the disease, and creates resources for patients, caregivers, and healthcare professionals. It also advocates for better care and policy change. For more information, visit https://www.fbc.uk.com/

About ImmunityBio

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield^™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the potential clinical and economic benefits of ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus BCG for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC); the potential for cost savings and improved healthcare outcomes in Medicare populations; future commercial adoption and reimbursement of ANKTIVA; the continued development and expansion of ImmunityBio's products; and the company's ability to advance its pipeline of immunotherapy candidates and achieve regulatory approvals for additional indications.

These forward-looking statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the health economic analysis results may not be predictive of real-world outcomes or may not lead to favorable reimbursement decisions; the risk that ANKTIVA may not achieve commercial success or market acceptance at anticipated levels; risks related to competition from other therapies for NMIBC, including TAR-200 and other investigational treatments; the risk that clinical trials may not demonstrate sufficient efficacy or safety to support additional regulatory approvals; risks related to manufacturing, supply chain, and product quality; uncertainties regarding healthcare reform, pricing pressures, and reimbursement policies; risks associated with intellectual property protection and potential infringement claims; risks associated with product promotion; general economic and market conditions; and other risks described in ImmunityBio's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent quarterly report on Form 10-Q filed on May 7, 2026.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. ImmunityBio undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this release, except as required by law.

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Contacts:

ImmunityBio Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com

Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com

Source: ImmunityBio, Inc.