ImmunityBio, BeiGene launch Phase 3 Trial to advance lung cancer immunotherapy
ImmunityBio, Inc. (NASDAQ: IBRX) has entered into a collaboration and supply agreement with BeiGene, Ltd., a global oncology company, to initiate a confirmatory Phase 3 clinical trial aimed at improving treatment outcomes for non-small cell lung cancer (NSCLC) patients who have developed resistance to checkpoint inhibitor therapy. The study, named ResQ201A-NSCLC, will evaluate the combination of BeiGene’s tislelizumab, a PD-1 checkpoint inhibitor, and ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln), an IL-15 agonist designed to enhance immune system function.
By leveraging the synergistic effects of checkpoint inhibition and immune stimulation, the trial seeks to confirm findings from previous studies that demonstrated prolonged overall survival in NSCLC patients treated with this combination therapy. If successful, the study could lead to a biologics license application (BLA) submission in 2025, paving the way for a new immunotherapy combination treatment for patients who have exhausted standard options.
How Does This Immunotherapy Combination Work Against Lung Cancer?
Lung cancer remains one of the most difficult cancers to treat, particularly when it advances beyond early stages. While checkpoint inhibitor therapy has transformed the treatment landscape for non-small cell lung cancer, a significant number of patients develop resistance, limiting long-term effectiveness.
ANKTIVA, an IL-15 superagonist, is designed to restore immune function by stimulating natural killer (NK) cells and T cells, overcoming tumor resistance and potentially extending survival rates. The molecule’s ability to reactivate the immune system has shown promising results in prior clinical trials, particularly in patients with NSCLC who no longer respond to checkpoint inhibitors.
The ResQ201A-NSCLC trial builds on the findings of the QUILT 3.055 study, which demonstrated that ANKTIVA combined with checkpoint inhibitor therapy could significantly improve patient outcomes. In that study, patients receiving the combination therapy achieved a median overall survival (mOS) of 17.1 months in those with PD-L1 ≥ 50%, while those who had relapsed on checkpoint inhibitors showed an mOS of 19.6 months. These results contrast sharply with traditional chemotherapy outcomes, where overall survival rates remain considerably lower.
Why Is This Phase 3 Trial Critical for NSCLC Treatment?
Lung cancer continues to be one of the leading causes of cancer-related deaths worldwide. In the U.S. alone, the American Cancer Society estimates that 226,650 new cases of lung cancer will be diagnosed in 2025, with 124,730 deaths attributed to the disease. Non-small cell lung cancer accounts for approximately 87% of all lung cancer cases, and for patients who develop resistance to checkpoint inhibitor therapy, treatment options are severely limited.
Checkpoint inhibitors work by blocking the PD-1/PD-L1 pathway, allowing T cells to attack tumors. However, once the cancer cells evade this mechanism, additional immune activation is required to re-engage the body’s defenses. ANKTIVA’s unique mechanism of action enhances T-cell proliferation and NK cell activation, effectively restoring the immune response in patients with checkpoint inhibitor-resistant NSCLC.
Dr. Patrick Soon-Shiong, Founder and Executive Chairman of ImmunityBio, emphasized the significance of this approach:
“The challenge oncologists face in the next five years is managing the increasing number of patients who no longer respond to checkpoint inhibitor therapy after an initial response. Our research shows that ANKTIVA can turn ‘cold’ tumors into ‘hot’ ones, reactivating immune cells and potentially extending survival in NSCLC patients who have exhausted other options.”
What Are the Objectives of the ResQ201A-NSCLC Trial?
This confirmatory Phase 3 trial aims to validate the efficacy and safety of ANKTIVA plus checkpoint inhibitor therapy in a larger, multi-center global study. The trial will enroll 462 patients across multiple sites and will assess both primary and secondary endpoints to determine the therapy’s effectiveness in treating advanced NSCLC.
The primary endpoint of the study is overall survival (OS), while secondary endpoints include:
- Disease control rate (DCR) – measuring the percentage of patients whose disease stabilizes or improves.
- Progression-free survival (PFS) – evaluating how long patients remain free of disease progression.
- Objective response rate (ORR) – determining the proportion of patients experiencing tumor shrinkage.
- Safety profile – assessing any adverse effects related to the combination therapy.
If the trial confirms previous findings, ImmunityBio and BeiGene anticipate submitting a BLA application for ANKTIVA plus checkpoint inhibitor therapy in 2025, potentially introducing a new standard of care for NSCLC patients who have limited treatment alternatives.
What Could This Mean for the Future of Lung Cancer Treatment?
The success of the ResQ201A-NSCLC trial could mark a significant advancement in immunotherapy for lung cancer, particularly for patients who have developed resistance to existing treatments. By combining checkpoint inhibitor therapy with an immune-stimulating cytokine, researchers are exploring an innovative approach to overcoming treatment resistance and improving long-term survival rates.
John V. Oyler, Co-Founder and CEO of BeiGene, emphasized the importance of this collaboration:
“ImmunityBio and BeiGene share a vision of advancing the next generation of immunotherapy combination treatments. We are excited to explore how tislelizumab plus ANKTIVA could reshape lung cancer treatment options, particularly for patients who currently have few effective choices.”
If the confirmatory Phase 3 trial successfully replicates the promising results of QUILT 3.055, it could establish a new immunotherapy approach that extends survival and improves quality of life for patients with non-small cell lung cancer.
What’s Next for ImmunityBio and BeiGene?
With global enrollment underway, ImmunityBio and BeiGene are advancing their efforts to finalize trial results and potentially secure regulatory approval. If approved, the therapy could serve as a foundational immunotherapy combination treatment for patients with checkpoint inhibitor-resistant NSCLC.
This development comes at a time when the demand for more effective lung cancer therapies continues to rise, and researchers are focusing on next-generation immunotherapy solutions that go beyond conventional approaches. By addressing the limitations of checkpoint inhibitor therapy, ImmunityBio and BeiGene aim to deliver a breakthrough treatment that redefines the standard of care for advanced lung cancer.
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