ImmunityBio’s ANKTIVA Reverses Lymphopenia, Improves Survival In CPI-Resistant Lung Cancer

ImmunityBio, Inc., announced groundbreaking results from its Phase 2 QUILT-3.055 study, showing that ANKTIVA® (nogapendekin alfa inbakicept-pmln) can reverse lymphopenia, a depletion of natural killer and T cells, in patients with checkpoint inhibitor (CPI)-resistant advanced non-small cell lung cancer (NSCLC). Reversal of lymphopenia was directly associated with significantly prolonged median overall survival (mOS). 

Lymphopenia, defined as an absolute lymphocyte count (ALC) below 1,000 cells/µL, is a frequent and serious side effect of chemotherapy, radiotherapy, and immunotherapy. It has long been linked with reduced survival across tumor types, but no approved therapies specifically address this condition. ANKTIVA is the first therapy under investigation that directly targets lymphopenia, aiming to restore immune cell populations critical for fighting cancer.

“These results present the clinical evidence that a low lymphocyte count, as measured by ALC levels, is an actionable, accessible biomarker to identify and treat therapy-induced lymphopenia in cancer patients with ANKTIVA and prolong overall survival. ANKTIVA is the first FDA-approved immunotherapy to stimulate natural killer cells, CD4+ CD8+ T cells and memory T cells, the very cells that are depleted resulting in lymphopenia, and that play a key role in the immune system’s fight against cancer. It is my belief that treating lymphopenia in patients with low NK and T cell count, is as essential as the well-established treatment of anemia (low red blood cells count) or of neutropenia (low neutrophil count), which occur as a consequence of chemotherapy, independent of tumor types. By taking this approach, we hope to herald in the paradigm change of treating the immune system itself and thereby allow the immune system to cure the cancer, regardless of its anatomical location. The long-term survival demonstrated in patients with bladder cancer and now in lung cancer provide evidence of the potential validity of this hypothesis, with ANKTVIA as the foundation of the BioShield™ platform,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 

Key data from the study showed that 80% of patients treated with ANKTIVA achieved an ALC above 1,200 cells/µL, with these patients experiencing a median overall survival of 15.8 months compared to 11.5 months for those who did not reach this threshold. Among all NSCLC patients, median OS was 14.3 months, including both second-line and third-line-plus patients. Additionally, 60% of patients with baseline lymphopenia experienced reversal during treatment. These findings support further investigation, with a Phase 3 trial (ResQ201A, NCT06745908) now underway evaluating ANKTIVA plus tislelizumab versus docetaxel in second-line NSCLC.