Biotechnology company ImmunityBio Inc (NASDAQ: IBRX) announced on Wednesday that it has entered into a collaboration with oncology company BeiGene Ltd, set to be renamed BeOne Medicines Ltd, to conduct a Phase 3 trial (ResQ201A-NSCLC) for non-small cell lung cancer (NSCLC). The study will evaluate the combination of ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln) and BeiGene's PD-1 inhibitor, tislelizumab.

The trial builds on the QUILT 3.055 Phase 2 study, which demonstrated prolonged overall survival and restored checkpoint inhibitor (CPI) efficacy in patients who had relapsed on CPI therapy. ANKTIVA, an IL-15 superagonist, stimulates the proliferation of NK cells and T cells, enhancing immune response and enabling CPI activity recovery.

With plans to file a biologics license application (BLA) by 2025, ImmunityBio aims to establish ANKTIVA as a treatment for second- and third-line NSCLC patients who have progressed on CPI therapies. The confirmatory global trial will involve 462 participants and measure overall survival as the primary endpoint.

NSCLC accounts for 87% of lung cancer cases, and the American Cancer Society projects 226,650 new diagnoses and 124,730 deaths in the US by 2025. The innovative immunotherapy combination aims to address the unmet needs of this challenging patient population.