A blood test to predict response to immunotherapy in various types of advanced cancer

For various advanced forms of cancer, immunotherapy with immune checkpoint inhibitors is an important treatment option. Immune checkpoint inhibitors are drugs that release certain “brakes” on the immune system. PD-1 is a protein found on certain immune cells, while PD-L1 can be found on tumor cells, among other places. When PD-L1 binds to PD-1, the immune cell is inhibited. PD-1/PD-L1 inhibitors block this binding, allowing immune cells to better recognize and fight cancer cells. However, not all patients respond equally well to this therapy. To date, the available testing method involves determining the level of the PD-L1 protein using a tissue sample from the tumor. However, this method offers only limited predictive accuracy regarding whether patients will benefit from the treatment and also involves an invasive procedure.

The aim of this observational study is to investigate whether a specific type of white blood cell—known as Ly6Ehi neutrophils—can serve as a biomarker in the blood to predict response to immunotherapy. To this end, a single blood sample is collected from patients before the start of their planned immunotherapy. Using a specialized laboratory technique called flow cytometry, the number of Ly6Ehi neutrophils in the blood is determined. A computer-based predictive model will then use these values to calculate how likely it is that patients will benefit from immunotherapy. The study is divided into two phases: In the first phase, the predictive model is developed and trained; in the second phase, the model’s predictions are verified against the actual course of the patients’ disease. Patients will not receive any additional treatment as part of this study; immunotherapy and diagnostic testing will be conducted independently of the study, in accordance with the standard of care for the respective cancer. The study comprises five cohorts, each corresponding to one of the cancers mentioned. The follow-up period lasts up to 24 months after the start of therapy.

Eligible participants include women and men aged 18 and older with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC), melanoma, head and neck carcinoma (HNSCC), renal cell carcinoma (RCC), or triple-negative breast cancer (TNBC), who, according to current standard of care, are scheduled to receive first-line treatment with a PD-(L)1 inhibitor, either as monotherapy or in combination with other active substances, according to current standard of care. Requirements for participation include, among other things, sufficiently good general health as well as normal blood count, kidney, and liver function.