ImmunityBio Announces Positive Results Demonstrating ANKTIVA® as a Lymphocyte Stimulating Agent in Combination With Checkpoint Inhibitors in Non-Small Cell Lung Cancer
- ANKTIVA® plus checkpoint inhibitor (CPI) therapy demonstrated statistically significant immune restoration across two clinical trials in 151 patients with non-small cell lung cancer (NSCLC)
- In first-line NSCLC (QUILT-2.023), a randomized study demonstrated a statistically significant and sustained increase in absolute lymphocyte count (ALC) from baseline with ANKTIVA plus CPI compared with CPI alone (p=0.0065), establishing ANKTIVA's contribution as a lymphocyte-stimulating agent
- In second- and later-line NSCLC (QUILT-3.055), a single-arm study demonstrated restoration or maintenance of ALC ≥1.0 × 10³ cells/µL in 77% of patients receiving ANKTIVA plus CPI (responders)
- Responders receiving ANKTIVA plus CPI experienced significantly longer overall survival compared with non-responders (median OS 16.2 vs 11.8 months; HR 0.52; p=0.0369), directly linking immune restoration to clinical benefit
- Patients achieving higher immune competence (ALC ≥1.2 ×10³ cells/µL) demonstrated additional survival benefit, with median OS of 21.1 months (HR 0.33; p=0.0009), independent of PD-L1 status, exceeding historical overall survival of 7-9 months with standard of care chemotherapy
- A randomized Phase 3 confirmatory trial (ResQ201A) comparing ANKTIVA plus CPI versus docetaxel in second-line NSCLC is ongoing
ImmunityBio, Inc. ((IBRX), a clinical-stage immunotherapy company, today announced positive results from its ANKTIVA (nogapendekin alfa inbakicept) clinical program in non-small cell lung cancer (NSCLC) based on two studies, QUILT-2.023 and QUILT-3.055. Across 151 patients spanning first-, second-, and later-line disease, ANKTIVA demonstrated statistically significant immune restoration and a consistent association between lymphocyte recovery and improved survival in checkpoint-experienced patients.
Checkpoint inhibitors such as pembrolizumab (Keytruda®) and nivolumab (Opdivo®) have transformed the treatment landscape for lung cancer; however, clinical benefit is often transient, and effective treatment options remain limited once patients progress following standard-of-care chemo-radiation and checkpoint inhibition.
QUILT-2.023 and QUILT-3.055 were designed to test the hypothesis that disease recurrence after checkpoint therapy reflects immune exhaustion and lymphocyte depletion, and that restoration of immune competence through activation of natural killer cells and CD8* cytotoxic T cells with ANKTIVA, in combination with checkpoint inhibitors, could improve outcomes.
"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."
Detailed results from QUILT-2.023 and QUILT-3.055 are being prepared for peer-review publication and future scientific presentations and serve as foundational safety and efficacy data demonstrating meaningful clinical benefit in patients with NSCLC who have failed all standards of care including checkpoint inhibitors.
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.
About QUILT-2.023
QUILT-2.023 (NCT03520686) is a Phase 3, open-label, multicohort study evaluating ANKTIVA® in combination with approved checkpoint inhibitor–based regimens as first-line treatment for patients with advanced or metastatic NSCLC. The study included three randomized cohorts and one exploratory cohort, each analyzed independently.
The primary randomized cohort enrolled 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.
About QUILT-3.055
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.
About ImmunityBio
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. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. 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 we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward Looking Statements
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