January 13, 2026 — Leads & Copy — ImmunityBio, Inc. (NASDAQ: IBRX) reported positive results from its ANKTIVA (nogapendekin alfa inbakicept) clinical program in non-small cell lung cancer (NSCLC), based on the QUILT-2.023 and QUILT-3.055 studies.
The studies, encompassing 151 patients across various stages of the disease, demonstrated statistically significant immune restoration and a consistent correlation between lymphocyte recovery and improved survival in patients previously treated with checkpoint inhibitors.
Checkpoint inhibitors, such as pembrolizumab (Keytruda®) and nivolumab (Opdivo®), have revolutionized lung cancer treatment. However, their clinical benefits are often short-lived, leaving limited options for patients who progress after standard chemo-radiation and checkpoint inhibition.
The QUILT-2.023 and QUILT-3.055 trials were designed to evaluate the hypothesis that disease recurrence post-checkpoint therapy indicates immune exhaustion and lymphocyte depletion. The trials tested whether restoring immune competence, by activating natural killer cells and CD8* cytotoxic T cells with ANKTIVA combined with checkpoint inhibitors, could enhance patient outcomes.
According to Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, the standard treatment for these patients remains cytotoxic chemotherapy, like docetaxel, which has significant toxicity and limited survival benefits. He noted that randomized trials have shown a median overall survival of about nine months with docetaxel. Soon-Shiong believes the study results indicate a potential shift toward Immunotherapy 2.0, which involves coordinating the 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.
Detailed findings from QUILT-2.023 and QUILT-3.055 are being prepared for peer-review publication and future scientific presentations. These findings provide key safety and efficacy data, demonstrating significant clinical benefits for NSCLC patients who have not responded to standard treatments, including checkpoint inhibitors.
The combination of ANKTIVA and checkpoint inhibitor therapy is protected by multiple patents, including U.S. Patent Nos. 9,925,247 and 11,071,774, with patent terms extending into 2032–2039.
QUILT-2.023 (NCT03520686) is a Phase 3, open-label, multicohort study assessing ANKTIVA® in combination with approved checkpoint inhibitor–based regimens as a first-line treatment for advanced or metastatic NSCLC. The study included three randomized cohorts and one exploratory cohort, each independently analyzed.
The primary randomized cohort included patients with stage III or IV squamous or nonsquamous NSCLC with PD-L1 expression ≥1% and no prior systemic therapy for advanced disease. Patients were randomized 1:1 to CPI alone or CPI plus ANKTIVA®. Stratification factors included CPI regimen, ECOG performance status, histology, and PD-L1 tumor proportion score. The primary endpoint was progression-free survival assessed by RECIST v1.1, with longitudinal absolute lymphocyte count prospectively incorporated as a key biological endpoint.
Enrollment was closed early following changes in the first-line NSCLC treatment landscape. All analyses were conducted according to the finalized protocol and statistical analysis plan.
QUILT-3.055 (NCT03228667) is a Phase 2b, multicohort, open-label study evaluating the addition of nogapendekin alfa inbakicept to continued PD-1/PD-L1 inhibitor therapy in patients with advanced solid tumors who progressed after prior checkpoint inhibition. The study enrolled heavily pretreated patients, including second- and later-line NSCLC.
Patients continued the same checkpoint inhibitor to which they had previously responded or stabilized, with ANKTIVA® administered subcutaneously in repeated six-week cycles. The primary objective prospectively linked immune biology to clinical outcomes by evaluating overall survival in relation to absolute lymphocyte count response, defined as achieving or maintaining a mean on-treatment ALC ≥1,000 cells/µL. Secondary endpoints included objective response rate, progression-free survival, duration of therapy, and safety.
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that sharply reduce or eliminate the need for standard high-dose chemotherapy.
Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Scientific and Medical Officer
Source: ImmunityBio
