ImmunityBio’s ANKTIVA® Reverses Lymphopenia and Extends Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Resistant to Checkpoint Therapy

• Severe lymphopenia, an adverse treatment effect associated with chemotherapy, radiotherapy, and immunotherapy, significantly lowers overall survival in non-small cell lung cancer and multiple types of cancer.1,2
• With ANKTIVA, the first FDA-approved lymphocyte-stimulating agent, 80% of patients exceeded or maintained absolute lymphocyte count (ALC) above 1,000 cells/µL.
• With ALC counts greater than 1,500 cells/µL, statistically significant prolonged median overall survival (OS) of 21.1 months occurred with patients alive ranging as long as over 4 years in stark contrast to the historical 7 to 9 months survival with docetaxel in these patients with advanced lung cancer.
• Findings from the Phase 2 QUILT-3.055 study presented at IASLC 2025 World Conference on Lung Cancer in Barcelona, Spain represent a paradigm change in a chemotherapy-free treatment of lung cancer by activating Natural Killer cells and T cells, the lymphocytes key to inducing cancer cell death.
• Patients are currently being enrolled in the randomized Phase 3 ResQ201A trial (NCT06745908), which is evaluating ANKTIVA + tislelizumab, a checkpoint inhibitor versus docetaxel alone in second-line NSCLC patients who have progressed after all standard therapies, including checkpoint inhibitors.

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced new paradigm changing findings from the Phase 2 QUILT-3.055 study, demonstrating ANKTIVA® (nogapendekin alfa inbakicept-pmln) reverses lymphopenia (low natural killer and T cells) in patients with checkpoint inhibitor-resistant advanced non-small cell lung cancer (NSCLC), with this reversal resulting in significant prolonged median overall survival (mOS). The results were presented (P1.11.78) on Sunday, September 7, at the IASLC 2025 World Conference on Lung Cancer in Barcelona, Spain. A video presentation of the data is available on X.com @DrPatSoonShiong.

Severe lymphopenia (loss of cancer-killing natural killer cells and T cells), is defined by the absolute lymphocyte count (ALC) of less than 1,000 lymphocyte cells/µL. This lowered ALC count is caused by the side effects resulting from current standards of treatment with radiotherapy, chemotherapy and immunotherapy, and is associated with reduced survival across all tumor types.1,2 Although reduced ALC is a recognized risk factor in a many cancers, it has largely been overlooked because no therapies have been approved to address lymphopenia. ANKTIVA is the first therapy under investigation specifically for this purpose.

“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,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “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.”

Specific findings from the Phase 2 QUILT-3.055 study include:

• Participants with a baseline ALC≥1,200 cells/µL and a group mean ALC≥1500 cells/µL at each on-treatment time point (N=44) had greater prolonged OS (21.1 months, 95% CI: 13.9. 42.1)
• mOS for study participants with NSCLC, including patients in second line (51%) and third line-plus treatment (49%), was 14.3 months (95% CI 11.7, 17.4), with 23 of 86 participants alive at data cutoff (December 2024)
• Among patients treated with ANKTIVA, 80% (69 of 86) exceeded an ALC of 1,200 cells/µL, with mOS of 15.8 months (95% CI 12.6, 21.9) compared to participants who failed to achieve ALC>1,200 cells/µL with mOS of 11.5 months (95% CI 4.2, 13.3); p=0.0057
• 60% of participants (25/42) treated with ANKTIVA reversed their lymphopenia during at least one on-treatment timepoint.
• The randomized Phase 3 ResQ201A trial (NCT06745908) is evaluating ANKTIVA + tislelizumab, a checkpoint inhibitor, versus docetaxel alone in second-line NSCLC patients who have progressed after all standard therapies, including checkpoint inhibitors. Patients interested in enrolling can inquire at CSSIFM.org.

The Phase 2 QUILT-3.055 study (NCT03228667) 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 AKNTIVA could improve overall survival by reversing lymphopenia and maintaining median ALC≥1,200 cells/µL. The primary endpoint was the change in ALC, including absolute cell count and percentage change from baseline, with ANKTIVA plus CPI during the study and its relationship to mOS. Statistical differences between OS among participants who failed to reverse lymphopenia (ALC