Saudi FDA Grants Accelerated Approval to ImmunityBio’s ANKTIVA®️ In Combination with Checkpoint Inhibitors for Metastatic Non-Small Cell Lung Cancer

ANKTIVA, in combination with an immune checkpoint inhibitor, has received accelerated approval from the Saudi Food and Drug Authority for the treatment of metastatic non-small cell lung cancer, marking the first approval in the world of a subcutaneously administered IL-15 receptor superagonist that restores immune competence
ANKTIVA + checkpoint inhibitor represents the first approved chemotherapy-free immunotherapy that activates both natural killer cells and killer T cells, heralding the era of immunotherapy 2.0
Accelerated approval was granted following SFDA review of clinical data from QUILT-3.055 in second-line and greater NSCLC patients and QUILT-2.023 in first-line NSCLC demonstrating significant immune restoration and a consistent association between lymphocyte recovery with improved survival in checkpoint-experienced patients
Newly approved therapy supports ImmunityBio’s mission to provide access to patients globally who could benefit from this chemotherapy-free combination treatment
CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the Saudi Food and Drug Authority (SFDA) has granted accelerated approval of ANKTIVA®️ (nogapendekin alfa inbakicept) for use in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following standard-of-care therapy. This marks the first approval of the Company’s innovative treatment for this indication anywhere in the world, and the first approval for subcutaneous administration.
“This approval represents a significant step forward for lung cancer patients in the Kingdom of Saudi Arabia and a meaningful milestone that we hope will pave the way toward additional approvals across a region where lung cancer claims far too many lives each year,” said Patrick Soon-Shiong, M.D., ImmunityBio’s Founder, Executive Chairman, and Global Chief Scientific and Medical Officer. “This combination of ANKTIVA plus a checkpoint inhibitor serves as a foundational backbone to immunotherapy 2.0, enabling activation of the complex immune system through subcutaneous outpatient therapy.”
Dr. Soon-Shiong added, “We are pleased that the Saudi FDA recognized the significance of ANKTIVA in restoring and maintaining immune competence and achieving prolonged survival in patients with lung cancer who have exhausted all standards of care. Clinical studies are ongoing to build on this ANKTIVA plus CPI backbone, as well as to evaluate CAR-NK cell therapy plus this combination in other indications. The goal of this combination immunotherapy approach is to orchestrate the immune system as a paradigm shift in the treatment of cancer across all tumor types. The NANT Cancer Vaccine (Patent #11,071,774) describes this vision of a next-generation immunotherapy designed to achieve durable remission and improved quality of life for patients with cancer.”
In the Kingdom of Saudi Arabia, lung cancer is one of the most prevalent cancer types overall, according to the Saudi Ministry of Health, and is the third most common cancer among males over 45 years of age, as discussed at the Inaugural Summit: USA-Saudi Biotech Alliance meeting.1
ImmunityBio plans to open a regional office in the Kingdom of Saudi Arabia to support physicians and health systems across the Middle East and North Africa. The company will collaborate with Biopharma Cigalah as its commercial and distribution partner in the region. Founded in 2007, BioPharma Cigalah provides the commercial infrastructure and capabilities needed to support therapies for serious diseases and expand patient access throughout the Middle East and North Africa.
“The incidence of lung and other cancers in the Middle East and North Africa is large and growing, demonstrating a significant unmet need for the kind of innovative treatments ImmunityBio is developing,” added Richard Adcock, President and CEO of ImmunityBio. “We are pursuing approvals across the region to fill that need, as well as investing in a regional office in Saudi Arabia in order to support our expansion into these growing markets.”
The accelerated approval for NSCLC is based on an observed increase in absolute lymphocyte count (ALC) associated with overall survival in single-arm clinical study (QUILT 3.055) together with the randomized trial QUILT 2.023 demonstrating the biological activity of ANKTIVA in restoring and maintaining lymphocyte count (see related announcement here). An ongoing confirmatory randomized trial in NSCLC is actively recruiting patients who have failed chemoradiation and checkpoint inhibitors (ResQ 201A).
The combination of ANKTIVA plus checkpoint inhibitor therapy is protected by multiple issued patents, including U.S. Patent Nos. 9,925,247 and 11,071,774, with patent terms extending into 2032–2039.