ImmunityBio's Anktiva: A Breakthrough in Advanced NSCLC Treatment

ImmunityBio's Anktiva has improved survival rates in advanced non-small cell lung cancer (NSCLC) by reversing lymphopenia, according to a study. The biotech company's lead product candidate, Anktiva, is an IL-15 superagonist antibody-cytokine fusion protein designed to bolster the immune system. The study found that Anktiva increased overall survival by 38.6% in patients with advanced NSCLC, highlighting its potential as a treatment for this aggressive form of cancer.

ImmunityBio, Inc. (NASDAQ: IBRX) has reported significant advancements in its lead product candidate, Anktiva, which has shown potential in reversing lymphopenia and improving survival rates in patients with advanced non-small cell lung cancer (NSCLC). The company presented findings from the Phase 2 QUILT-3.055 study at the IASLC 2025 World Conference on Lung Cancer in Barcelona, Spain.

The study demonstrated that Anktiva, an interleukin-15 (IL-15) receptor agonist, effectively reversed lymphopenia, a condition that leads to reduced survival rates in cancer patients. By reversing lymphopenia, Anktiva increased overall survival by 38.6% in patients with advanced NSCLC. This is a substantial improvement compared to historical survival rates of 7 to 9 months with docetaxel, a standard chemotherapy treatment for these patients.

The Phase 2 QUILT-3.055 study enrolled participants with advanced NSCLC who had developed resistance to checkpoint inhibitor immunotherapy (CPI). Participants continued treatment with the same CPI on which they had progressed, combined with Anktiva, to test the hypothesis that Anktiva could improve overall survival by reversing lymphopenia and maintaining median absolute lymphocyte count (ALC) above 1,200 cells/µL.

Key findings from the study include:
- 80% of participants exceeded an ALC of 1,200 cells/µL, with a median overall survival (mOS) of 15.8 months.
- Participants who maintained an ALC above 1,500 cells/µL had a statistically significant prolonged median overall survival of 21.1 months.
- 60% of participants treated with Anktiva reversed their lymphopenia during at least one on-treatment timepoint.

The randomized Phase 3 ResQ201A trial (NCT06745908) is currently evaluating Anktiva in combination with tislelizumab, a checkpoint inhibitor, versus docetaxel alone in second-line NSCLC patients who have progressed after all standard therapies, including checkpoint inhibitors.

ImmunityBio's Anktiva is a first-in-class IL-15 agonist IgG1 fusion complex that activates natural killer cells, CD4+ CD8+ T cells, and memory T cells. By activating these key immune cells, Anktiva overcomes the tumor escape phase and restores memory T cell activity, resulting in prolonged duration of complete response.

These findings represent a paradigm shift in the treatment of lung cancer, suggesting that addressing lymphopenia could be as essential as treating other forms of anemia or neutropenia. ImmunityBio believes that treating lymphopenia in patients with low NK and T cell count is crucial for the immune system to cure cancer, regardless of its anatomical location.

References:
[1] https://www.stocktitan.net/news/IBRX/immunity-bio-s-anktiva-reverses-lymphopenia-and-extends-overall-rrha9ntidalk.html