ImmunityBio Inc. has announced positive results from its ANKTIVA (nogapendekin alfa inbakicept) clinical program in non-small cell lung cancer (NSCLC), based on data from two studies, QUILT-2.023 and QUILT-3.055. The results, which have already been presented, indicate that ANKTIVA in combination with checkpoint inhibitor $(CPI)$ therapy demonstrated statistically significant immune restoration across 151 patients with NSCLC. In the first-line setting, a randomized trial showed a significant and sustained increase in absolute lymphocyte count $(ALC)$ with ANKTIVA plus CPI compared to CPI alone. In second- and later-line NSCLC, a single-arm study found that 77% of patients maintained or restored ALC ≥1.0 × 10³ cells/µL. Responders experienced a median overall survival of 16.2 months compared to 11.8 months for non-responders, and patients with higher immune competence (ALC ≥1.2 ×10³ cells/µL) demonstrated a median overall survival of 21.1 months. A randomized Phase 3 confirmatory trial (ResQ201A) comparing ANKTIVA plus CPI versus docetaxel in second-line NSCLC is currently ongoing.

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