ImmunityBio Reports Positive QUILT Trial Data For ANKTIVA In Advanced Lung Cancer; Demonstrates Immune Restoration And Survival Benefit

ImmunityBio has reported encouraging clinical data for ANKTIVA (nogapendekin alfa inbakicept) in patients with non-small cell lung cancer, based on results from the QUILT-2.023 and QUILT-3.055 studies. The trials included 151 patients across first-line through later-line treatment settings and demonstrated statistically significant immune system restoration, along with a strong correlation between lymphocyte recovery and improved survival in patients previously treated with checkpoint inhibitors.

Although checkpoint therapies such as Keytruda and Opdivo have changed the standard of care for lung cancer, many patients eventually stop responding and face limited options once their disease progresses. The ImmunityBio studies focused on this difficult-to-treat population, where immune exhaustion and reduced lymphocyte levels are believed to drive resistance to existing therapies.

“Today, the default standard of care for these patients remains cytotoxic chemotherapy such as docetaxel, which is associated with substantial toxicity and limited survival benefit,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “Large, randomized trials have demonstrated median overall survival of approximately nine months with docetaxel. The results from these studies support a potential paradigm shift toward what we define as Immunotherapy 2.0, which is the coordinated activation of the innate immune system through natural killer cells and the adaptive immune system through T cells to restore immune competence and extend survival.”

The two QUILT trials were designed around the idea that restoring immune function could help overcome this resistance. ANKTIVA works by activating natural killer cells and CD8+ cytotoxic T cells, key components of the immune response against tumors. When combined with checkpoint inhibitors, the therapy aims to re-energize the immune system and improve tumor control in patients whose cancers have returned or progressed.

ImmunityBio also noted that the ANKTIVA and checkpoint inhibitor combination is protected by a strong intellectual property portfolio, including U.S. patents extending into the 2032–2039 period. These protections support the company’s long-term strategy to develop and commercialize the therapy as a new treatment option for lung cancer patients who have exhausted standard therapies.