The U.S Food and Drug Administration (FDA) has granted approval to ImmunityBio, Inc. (NASDAQ: IBRX) for their immunotherapy treatment, ANKTIVA® (N-803), in combination with Bacillus Calmette-Guérin (BCG), for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. ANKTIVA®, an interleukin-15 superagonist, offers a promising alternative for individuals whose bladder cancer does not adequately respond to traditional therapies.


FDA Approval for Bladder Cancer Therapy a Lifeline for ImmunityBio

After overcoming a merger and a previous FDA rejection, ImmunityBio, led by South-African American celebrity businessman and biotech entrepreneur Dr. Patrick Soon-Shiong, has achieved its first U.S. approval for the cancer immunotherapy drug ANKTIVA®. This recent FDA approval of ImmunityBio’s combination therapy for a specific type of bladder cancer signifies a significant milestone for the company in successfully bringing the product to market. This decision comes after the FDA’s initial denial last year due to manufacturing deficiencies. Despite these earlier regulatory setbacks and doubts about its future viability in the event of another rejection, ImmunityBio’s perseverance has paid off, with the approval providing a much-needed boost.

Initially created by Altor BioScience, ANKTIVA®’s successful development and subsequent approval by ImmunityBio mark a crucial advancement in the field of cancer immunotherapy. Designated as an FDA Breakthrough Therapy, ANKTIVA® is an IL-15 receptor agonist that activates natural killer (NK) and T-cells to attack tumors and cancer cells. Then, by stimulating memory T cells, it facilitates a lasting immune response, with some patients showing complete responses lasting over 47 months. Approved for maintenance therapy for up to 37 months alongside BCG, ANKTIVA® has demonstrated tolerable side effects and promising efficacy, exceeding benchmarks set by experts at the International Bladder Cancer Group (IBCG).


ANKTIVA® Labeled a Next-generation Immunotherapy, Leveraging a “Triangle Offense” Approach

According to the National Cancer Institute, bladder cancer is expected to afflict 83,190 individuals in the United States this year, with 16,840 fatalities. This represents 4.2% of new cancer cases and 2.8% of cancer-related deaths. Dr. Patrick Soon-Shiong, the executive chairman of ImmunityBio and partial owner of the Los Angeles Lakers, has expressed enthusiasm for the FDA’s approval of ANKTIVA®, labeling it as a “next-generation immunotherapy.” Drawing on basketball terminology, Soon-Shiong likened Anktiva’s mechanism to a “triangle offense,” highlighting its ability to advance immunotherapy beyond reliance solely on T cells. “The triangle offense of tumor cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin.”

ANKTIVA® is administered in conjunction with the BCG vaccine, traditionally employed in tuberculosis treatment but also used for specific types of bladder cancer. This combination targets vaccine-resistant forms of bladder cancer that have not yet spread and typically affects approximately 70-85% of patients. Additionally, it fills a vital treatment gap for individuals with BCG-unresponsive bladder cancer, which carries an increased risk of metastasis. Standard treatments generally involve surgical ablation alongside chemotherapy or the BCG vaccine. However, approximately 40% of patients do not respond to BCG, necessitating more aggressive interventions like bladder removal. The QUILT 3.032 trial demonstrated promising results as published in the NEJM, with ANKTIVA® plus BCG achieving a 71% complete response rate, a median response duration of 26.6 months, and a 90% reduction in the need for bladder removal surgery.


Game-Changing Bladder Cancer Treatment: Mid-May Release with Projected $900 Million Sales

ANKTIVA® joins the competitive landscape against Merck & Co.’s PD-1 inhibitor Keytruda, and Ferring Pharmaceuticals’ gene therapy Adstiladrin in treating BCG NMIBC with CIS. Keytruda is administered intravenously, while both ANKTIVA® and Adstiladrin are administered directly through the bladder. Keytruda was approved in 2020, and Adstiladrin was cleared in 2022. Both are competitors of ANKTIVA®, in addition to CG Oncology’s cretostimogene grenadenorepvec, which is currently in Phase 3 trials for BCG-unresponsive NMIBC.

ImmunityBio plans to launch ANKTIVA® in the US by mid-May 2024, with pricing details pending. Pharma data intelligence outlet Evaluate has included ANKTIVA® in its list of the top 10 anticipated drug launches for this year. They project that this immunotherapy could achieve sales of nearly $900 million by 2028. According to ImmunityBio’s executive chair, Soon-Shiong, and CEO Richard Adcock, ANKTIVA®’s advantage lies in its capacity to induce “durable complete remission.” Besides NMIBC, ImmunityBio is developing ANKTIVA® for various oncology indications, including high-grade papillary disease and BCG treatment-naïve NMIBC, as well as for solid tumors, blood cancers, and HIV. “ImmunityBio aims to generate cancer-free long-term overall survival,” Soon-Shiong said, adding that “the big goal is to advance cancer care beyond just recognizing you get a short-term response.”

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