ImmunityBio Announces Collaboration with BeiGene on Confirmatory Phase 3 Trial of ANKTIVA and PD-1 Checkpoint Inhibitor Combination in Non-Small Cell Lung Cancer

ImmunityBio, Inc. (NASDAQ: IBRX) today announced it has entered into a collaboration and supply agreement with BeiGene, Ltd. (to be changed to BeOne Medicines, Ltd.), a global oncology company, to conduct a confirmatory randomized Phase 3 clinical trial (ResQ201A-NSCLC), combining BeiGene's tislelizumab, a PD-1 checkpoint inhibitor (CPI), and ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln). The Phase 3 ResQ201A-NSCLC study (NCT06745908) aims to confirm the efficacy and safety of combination ANKTIVA plus CPI therapy previously demonstrated in the trial QUILT 3.055 and provide evidence of the potential for these two immunotherapeutic agents to improve overall survival in patients with advanced or metastatic NSCLC who have acquired resistance to immune CPI therapy.

The Phase 3 trial design is based on the synergistic potential already demonstrated in the QUILT 3.055 study that a CPI and ANKTIVA, an IL-15 superagonist, prolongs overall survival (OS) in the study population compared to historical controls in this setting. In Phase 1 and 2 studies, ANKTIVA has demonstrated the capability of rescuing T cells, and thus CPI efficacy, through the molecule’s unique mechanism of action. ANKTIVA is the first FDA approved molecule that has demonstrated the ability to increase lymphocytes via its proliferative IL-15 stimulatory action. ANKTIVA stimulates the proliferation of natural killer cells and CD4+ and CD8+ T cells, which in turn restores MHC-1 presentation, allowing T cells to regain their cytotoxic activity, and thereby rescue CPI activity.

Multiple Phase 1 and 2 studies have demonstrated prolonged overall survival with this combination approach, in comparison to historical results with chemotherapy in this patient population. ^1,2 In these multi-site trials, the combination of ANKTIVA plus the CPI, with no intervening therapy when the patient progressed on the CPI, demonstrated a median OS (mOS) of 17.1 months (95% CI: 4.6, NR) in patients with PD-L1 ≥ 50% and a mOS of 19.6 months (95% CI: 6.2, NR) in patients who relapsed on checkpoint inhibitor. QUILT 3.055 confirmed these findings with a mOS of 14.1 months (95% CI: 11.7, 16.3), as presented at World Lung on Oct 2024.^{3, 4}