BeiGene and ImmunityBio Initiate Phase III ResQ201A-NSCLC Trial of Tislelizumab Plus Anktiva (IL-15) in PD-1-Resistant Non-Small Cell Lung Cancer

▎Armstrong

On January 29, 2025, ImmunityBio announced a collaboration with BeOne Medicines to initiate the Phase III clinical trial ResQ201A-NSCLC, evaluating the combination of the PD-1 antibody tislelizumab and IL-15 as a second-line treatment for patients with PD-1 resistant NSCLC.

ImmunityBio previously achieved excellent data in the Phase II clinical trial QUILT 3.055 for second-line/third-line treatment of NSCLC and plans to submit an application for marketing authorization in 2025 based on this clinical data and the ongoing Phase III validation trial.

According to the previously disclosed QUILT 3.055 clinical data, mOS reached 14.1 months.

According to the disclosed data, the mOS of Anktiva+PD-1 combination therapy for patients with high PD-L1 expression was 17.1 months.For NSCLC with PD-1 resistance, the mOS was 19.6 months.

Summary

Cytokines are expected to reach a new turning point, becoming another key breakthrough in the field of tumor immunotherapy. Tumor immunotherapy represented by PD-1 has achieved breakthrough progress in the past decade, but the exploration of new immunotherapy targets and mechanisms has mostly ended in failure, including biased IL-2. In 2024, ImmunityBio's locally administered IL-15 was approved for marketing, and a systemic administration treatment for NSCLC will be submitted for marketing application in 2025. In addition, Innovent Biologics' PD-1/IL-2 achieved breakthrough efficacy in Phase I clinical trials and has already initiated Phase II clinical trials.