ImmunityBio Positive Results for Lymphocyte Stimulating Agent in 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

https://www.businesswire.com/news/home/20260113762801/en/ImmunityBio-Announces-Positive-Results-Demonstrating-ANKTIVA-as-a-Lymphocyte-Stimulating-Agent-in-Combination-With-Checkpoint-Inhibitors-in-Non-Small-Cell-Lung-Cancer