ImmunityBio has entered a supply agreement and partnership with BeiGene for conducting a confirmatory Phase III ResQ201A-NSCLC trial combining tislelizumab and Anktiva to treat advanced or metastatic non-small cell lung cancer (NSCLC) patients.

Tislelizumab is BeiGene’s programmed cell death protein 1 (PD-1) checkpoint inhibitor and Anktiva is an interleukin-15 (IL-15) superagonist from ImmunityBio.

The trial aims to confirm the safety and efficacy of this combination in subjects who have developed resistance to immune checkpoint inhibitor (CPI) therapy.

It will be conducted across several worldwide sites and is anticipated to enrol 462 subjects.

Overall survival (OS) is the primary endpoint of this trial, with secondary endpoints being safety, progression-free survival, disease control rate, and objective response rate.

This study builds on the promising outcomes of the QUILT 3.055 Phase II trial, which indicated that the combination of a CPI and Anktiva could extend OS in this particular patient group.

Anktiva, in Phase I and II trials, has shown the ability to rescue T cells and enhance the efficacy of CPI through its IL-15 stimulatory action.

A biologics licence application (BLA) filing is being planned by ImmunityBio based on these outcomes for the CPI and therapy combo as a second or third-line treatment for NSCLC subjects who have progressed on CPI therapy.

ImmunityBio executive chairman and founder Dr Patrick Soon-Shiong said: “The finding that these ‘cold’ tumours, which have evaded T cells, can now be rendered ‘hot’ through the activation of natural killer cells with Anktiva, is exciting.

“To our knowledge, Anktiva is the first approved cytokine to address low white cell count (lymphopenia), which occurs following chemo-immunotherapy and radiotherapy.”

In August 2024, the company launched the QUILT 502 Phase I/II trial to evaluate Anktiva in combination with the investigational AdHER2DC vaccine for individuals with HER2-expressing endometrial cancer.