An Asia-based cancer diagnostic firm, ACT Genomics, and UC San Diego Moores Cancer Center have launched a study to evaluate gene expressions associated with tumor microenvironment in PD-1 treatment outcome prediction for 100 melanoma patients.
The study relies on a chip-based multiplex qPCR assay to characterize the expression signature of 92 immune-related genes, such as antigen presentation machinery, immune checkpoint molecules, nine different immune cell populations, and signaling molecules relevant to the tumor microenvironment. The assay serves to characterize each oncology patient’s unique immune signature to optimize immunotherapy efficacy.
The proprietary tumor microenvironment gene expression test, named ACTTME , was designed by ACT Genomics to overcome the current challenges of processing low quantity and poor quality FFPE samples in clinical settings and provide a cost-effective tool to guide the clinical outcome of immune-checkpoint inhibitors, reinforcing the concept of precision medicine.
“We are excited to demonstrate the technical capability and clinical values of ACTTME through this collaboration,” said ACT Genomics CSO Shu Jen Chen. “The ability to accommodate poor quality (>300bp ≥15%) RNA samples derived from FFPE and to start with the RNA quantity as low as 25 ng suggests the assay has higher detection sensitivity and better clinical applicability for the development of novel companion diagnostics of immune-checkpoint inhibitors.”
This study will first evaluate tumor microenvironment gene expression in correlation to PD-1 treatment outcome to develop algorithms for cell-type deconvolution and then examine the feasibility of immunotherapy treatment response prediction from gene expression results.
Dr. Hua Chien Chen, CEO of ACT Genomics, believes the outcome of this collaboration could provide a new strategy for immunotherapy treatment selection and patient stratification outside of the routine PD-L1 IHC staining, microsatellite instability-high (MSI-H), and tumor mutational burden (TMB). “While immune checkpoint inhibitors have revolutionized cancer treatment, the treatment outcomes for the majority of the patients have been suboptimal. There is still a lack of predictive biomarkers accounting for an individual’s intrinsic immune system and tumor-induced immune microenvironment.”
The investigators on this study, Dr. Shumei Kato and Dr. Razelle Kurzrock from the Center for Personalized Cancer Therapy at UC San Diego Moores Cancer Center, emphasized the importance of combining genomic profiling information and translational data to help decipher the biological mechanisms driving tumor susceptibility and resistance.
While the study focuses on melanoma patients, the assay could potentially be applied in guiding immunotherapy for other solid tumors.