ImmunityBio and BeiGene Collaborate on Phase 3 ANKTIVA® Trial for NSCLC Treatment
Thursday, January 30, 2025
ImmunityBio has announced a collaboration and supply agreement with BeiGene to conduct a confirmatory Phase 3 clinical trial for a combination therapy in non-small cell lung cancer (NSCLC).
ANKTIVA is an IL-15 agonist designed to enhance immune responses against cancer. Interleukin-15 (IL-15) is crucial for the development, maintenance, and function of immune cells such as natural killer and CD8+ T cells, which are responsible for targeting and destroying cancer cells.
ANKTIVA was approved by the US Food and Drug Administration (FDA) in 2024 for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (CIS), with or without papillary tumours.
Lung cancer remains one of the most common cancers in the United States, with an estimated 226,650 new cases and 124,730 deaths expected in 2025. NSCLC accounts for approximately 87% of all lung cancer diagnoses, and treatment options remain limited for patients with metastatic disease.
The study, known as ResQ201A-NSCLC (NCT06745908), will assess the efficacy and safety of combining ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln) with BeiGene’s PD-1 checkpoint inhibitor, tislelizumab, in patients with advanced or metastatic NSCLC who have developed resistance to previous checkpoint inhibitor therapy.
The trial builds on previous findings from the QUILT 3.055 study, which indicated that the combination of ANKTIVA, an IL-15 superagonist, and a PD-1 checkpoint inhibitor could extend overall survival in this patient group.
ANKTIVA has shown the ability to enhance immune response by stimulating the proliferation of natural killer cells and CD4+ and CD8+ T cells. This action restores major histocompatibility complex class I (MHC-I) presentation, allowing T cells to regain cytotoxic activity and improving the efficacy of checkpoint inhibitors.
The Phase 3 trial will be conducted at multiple sites worldwide and aims to enrol 462 participants. The primary goal is to assess overall survival, while secondary endpoints include disease control rate, progression-free survival, objective response rate, and safety.
The collaboration between ImmunityBio and BeiGene reflects a shared commitment to advancing next-generation immunotherapies to address unmet medical needs in oncology.
The combination of ANKTIVA and tislelizumab aims to improve treatment outcomes for patients with NSCLC who have exhausted other options.
Source: immunitybio.com
